Comparison of two psycho-educational family group interventions for improving psycho-social outcomes in persons with spinal cord injury and their caregivers: a randomized-controlled trial of multi-family group intervention versus an active education control condition.

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Dyck, Dennis G; Weeks, Douglas L; Gross, Sarah; Lederhos Smith, Crystal; Lott, Hilary A; Wallace, Aimee J; Wood, Sonya M

2016-07-26

Over 12,000 individuals suffer a spinal cord injury (SCI) annually in the United States, necessitating long-term, complex adjustments and responsibilities for patients and their caregivers. Despite growing evidence that family education and support improves the management of chronic conditions for care recipients as well as caregiver outcomes, few systematic efforts have been made to involve caregivers in psycho-educational interventions for SCI. As a result, a serious gap exists in accumulated knowledge regarding effective, family-based treatment strategies for improving outcomes for individuals with SCI and their caregivers. The proposed research aims to fill this gap by evaluating the efficacy of a structured adaptation of an evidence-based psychosocial group treatment called Multi-Family Group (MFG) intervention. The objective of this study is to test, in a randomized-controlled design, an MFG intervention for the treatment of individuals with SCI and their primary caregivers. Our central hypothesis is that by providing support in an MFG format, we will improve coping skills of persons with SCI and their caregivers as well as supportive strategies employed by caregivers. We will recruit 32 individuals with SCI who have been discharged from inpatient rehabilitation within the previous 3 years and their primary caregivers. Patient/caregiver pairs will be randomized to the MFG intervention or an active SCI education control (SCIEC) condition in a two-armed randomized trial design. Participants will be assessed pre- and post-program and 6 months post-program. Intent to treat analyses will test two a priori hypotheses: (1) MFG-SCI will be superior to SCIEC for SCI patient activation, health status, and emotion regulation, caregiver burden and health status, and relationship functioning, and (2) MFG will be more effective for individuals with SCI and their caregivers when the person with SCI is within 18 months of discharge from inpatient rehabilitation compared

Evaluation of two health education interventions to improve the varicella vaccination: a randomized controlled trial from a province in the east China.

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Hu, Yu; Li, Qian; Chen, Yaping

2018-01-16

We evaluated the effect of two Elaboration Likelihood Model (ELM)-based health educational interventions on varicella vaccine (VarV) vaccination among pregnant women in a province in the east China. A prospective randomized controlled trial was conducted among 200 pregnant women with ≥12 gestation weeks to test two interventions, including a messaging video and a messaging booklet. The participants were randomly assigned into the control group, the video group or the booklet group. The VarV coverage at 12 and 24 months old was compared among the children of the three groups and relative risks (RRs) were calculated, by using the coverage of the control group as reference. The timeliness of VarV was also assessed. Furthermore, differences in the effects on the knowledge and attitude of VarV vaccination between the two interventions was evaluated. The VarV coverage of their children by 24 months of age was 86.4%, 76.1% and 56.7% for the video group, the booklet group and the control group, respectively. The relative risks (RRs) for the coverage of VarV at 24 months of age were 4.8 (95% CI: 2.06-11.3) for the video group and 2.4 (95% CI: 1.2-5.1) for the booklet group. The means of delays were 57.3 days in the video group, 76.9 days in the booklet group, and 100.6 days in the control group. The proportion of women who intended to vaccinate their children with VarV was higher in the video group than the booklet group (93.9% vs. 82.1%, p < 0.05). Our findings indicated that perinatal health education through booklet or video could improve the coverage and schedule adherence for children's VarV vaccination.

The impact of group music therapy on depression and cognition in elderly persons with dementia: a randomized controlled study.

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Chu, Hsin; Yang, Chyn-Yng; Lin, Yu; Ou, Keng-Liang; Lee, Tso-Ying; O'Brien, Anthony Paul; Chou, Kuei-Ru

2014-04-01

The aims of this study were to determine the effectiveness of group music therapy for improving depression and delaying the deterioration of cognitive functions in elderly persons with dementia. The study had a prospective, parallel-group design with permuted-block randomization. Older persons with dementia (N = 104) were randomly assigned to the experimental or control group. The experimental group received 12 sessions of group music therapy (two 30-min sessions per week for 6 weeks), and the control group received usual care. Data were collected 4 times: (1) 1 week before the intervention, (2) the 6th session of the intervention, (3) the 12th session of the intervention, and (4) 1 month after the final session. Group music therapy reduced depression in persons with dementia. Improvements in depression occurred immediately after music therapy and were apparent throughout the course of therapy. The cortisol level did not significantly decrease after the group music therapy. Cognitive function significantly improved slightly at the 6th session, the 12th session, and 1 month after the sessions ended; in particular, short-term recall function improved. The group music therapy intervention had the greatest impact in subjects with mild and moderate dementia. The group music intervention is a noninvasive and inexpensive therapy that appeared to reduce elders' depression. It also delayed the deterioration of cognitive functions, particularly short-term recall function. Group music therapy may be an appropriate intervention among elderly persons with mild and moderate dementia.

Effectiveness of a group-based self-management program for people with chronic fatigue syndrome: a randomized controlled trial.

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Pinxsterhuis, Irma; Sandvik, Leiv; Strand, Elin Bolle; Bautz-Holter, Erik; Sveen, Unni

2017-01-01

To evaluate the effectiveness of a group-based self-management program for people with chronic fatigue syndrome. A randomized controlled trial. Four mid-sized towns in southern Norway and two suburbs of Oslo. A total of 137 adults with chronic fatigue syndrome. A self-management program including eight biweekly meetings of 2.5 hours duration. The control group received usual care. Primary outcome measure: Medical Outcomes Study-Short Form-36 physical functioning subscale. Fatigue severity scale, self-efficacy scale, physical and mental component summary of the Short Form-36, and the illness cognition questionnaire (acceptance subscale). Assessments were performed at baseline, and at six-month and one-year follow-ups. At the six-month follow-up, a significant difference between the two groups was found concerning fatigue severity ( p = 0.039) in favor of the control group, and concerning self-efficacy in favor of the intervention group ( p = 0.039). These significant differences were not sustained at the one-year follow-up. No significant differences were found between the groups concerning physical functioning, acceptance, and health status at any of the measure points. The drop-out rate was 13.9% and the median number of sessions attended was seven (out of eight). The evaluated self-management program did not have any sustained effect, as compared with receiving usual care.

Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial.

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Siewe, Jan; Bredow, Jan; Oppermann, Johannes; Koy, Timmo; Delank, Stefan; Knoell, Peter; Eysel, Peer; Sobottke, Rolf; Zarghooni, Kourosh; Röllinghoff, Marc

2014-09-05

The 360° fusion of lumbar segments is a common and well-researched therapy to treat various diseases of the spine. But it changes the biomechanics of the spine and may cause adjacent segment disease (ASD). Among the many techniques developed to avoid this complication, one appears promising. It combines a rigid fusion with a flexible pedicle screw system (hybrid instrumentation, "topping off"). However, its clinical significance is still uncertain due to the lack of conclusive data. The study is a randomized, therapy-controlled, two-centre trial conducted in a clinical setting at two university hospitals. If they meet the criteria, outpatients presenting with degenerative disc disease, facet joint arthrosis or spondylolisthesis will be included in the study and randomized into two groups: a control group undergoing conventional fusion surgery (PLIF - posterior lumbar intervertebral fusion), and an intervention group undergoing fusion surgery using a new flexible pedicle screw system (PLIF + "topping off"), which was brought on the market in 2013. Follow-up examination will take place immediately after surgery, after 6 weeks and after 6, 12, 24 and 36 months. An ongoing assessment will be performed every year.Outcome measurements will include quality of life and pain assessments using validated questionnaires (ODI - Ostwestry Disability Index, SF-36™ - Short Form Health Survey 36, COMI - Core Outcome Measure Index). In addition, clinical and radiologic ASD, sagittal balance parameters and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications (e.g. implant failure), adverse events, and serious adverse events will be monitored and documented throughout the study. New hybrid "topping off" systems might improve the outcome of lumbar spine fusion. But to date, there is a serious lack of and a great need

Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

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Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, Stephen

2012-12-24

Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. To evaluate the effectiveness of the group diabetes education programmeOutcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Pan African Clinical Trial Registry PACTR201205000380384.

Group Singing as a Therapy during Diabetes Training--A Randomized Controlled Pilot Study.

Science.gov (United States)

Groener, J B; Neus, I; Kopf, S; Hartmann, M; Schanz, J; Kliemank, E; Wetekam, B; Kihm, L; Fleming, T; Herzog, W; Nawroth, P P

2015-11-01

Comprehensive diabetes treatment has been shown to reduce quality of life in diabetic patients. However, there is evidence to suggest that group singing can have positive effects on quality of life in various clinical settings. In this randomized controlled pilot study, the effect of singing as a therapy to reduce stress and improve quality of life was investigated in insulin-dependent diabetic patients, undergoing a lifestyle intervention program. Patients from the singing group felt less discontented following treatment. This effect, however, was lost after 3 months. No effect on serum cortisol and plasma adrenocorticotropic hormone (ACTH) levels could be seen when comparing the singing group with the control group, although reduced levels of ACTH and cortisol 3 days after treatment could be found and were still present after 3 months within the group of patients who undertook singing as a therapy. Singing led to an increase in bodyweight, which interestingly had no effect on glucose control or methylglyoxal levels. Therefore, singing during a lifestyle intervention program for insulin-dependent diabetic patients had a short lasting and weak effect on patients' mood without affecting glucose control, but no significant effect on stress related hormones. © Georg Thieme Verlag KG Stuttgart · New York.

Timing and approaches in congenital cataract surgery: a four-year, two-layer randomized controlled trial

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Jin-Chao Liu

2017-12-01

Full Text Available "AIM: To compare visual prognoses and postoperative adverse events of congenital cataract surgery performed at different times and using different surgical approaches. METHODS: In this prospective, randomized controlled trial, we recruited congenital cataract patients aged 3mo or younger before cataract surgery. Sixty-one eligible patients were randomly assigned to two groups according to surgical timing: a 3-month-old group and a 6-month-old group. Each eye underwent one of three randomly assigned surgical procedures, as follows: surgery A, lens aspiration (I/A; surgery B, lens aspiration with posterior continuous curvilinear capsulorhexis (I/A+PCCC; and surgery C, lens aspiration with posterior continuous curvilinear capsulorhexis and anterior vitrectomy (I/A+PCCC+A-Vit. The long-term best-corrected visual acuity (BCVA and the incidence of complications in the different groups were compared and analyzed. RESULTS: A total of 57 participants (114 eyes with a mean follow-up period of 48.7mo were included in the final analysis. The overall logMAR BCVA in the 6-month-old group was better than that in the 3-month-old group (0.81±0.28 vs 0.96±0.30; P=0.02. The overall logMAR BCVA scores in the surgery B group were lower than the scores in the A and C groups (A: 0.80±0.29, B: 1.02±0.28, and C: 0.84±0.28; P=0.007. A multivariate linear regression revealed no significant relationships between the incidence of complications and long-term BCVA. CONCLUSION: It might be safer and more beneficial for bilateral total congenital cataract patients to undergo surgery at 6mo of age than 3mo. Moreover, with rigorous follow-up and timely intervention, the postoperative complications in these patients are treatable and do not compromise visual outcomes."

Two-group Current-equivalent Parameters for Control Rod Cells. Autocode Programme CRCC

Energy Technology Data Exchange (ETDEWEB)

Norinder, O; Nyman, K

1962-06-15

In two-group neutron diffusion calculations there is mostly necessary to describe the influence of control rods by equivalent homogeneous two-group parameters in regions about the control rods. The problem is solved for a control rod in a medium characterized by two-group parameters. The property of fast and thermal neutr. on current equivalence is selected to obtain equivalent two-group parameters for a homogeneous cell with the same radius as the control rod cell. For the parameters determined one obtains the same fast and thermal neutron current into the rod cell and the equivalent cell independent of the fast and thermal flux amplitudes on the cell boundaries. The equivalent parameters are obtained as a solution of a system of transcendental equations. A Ferranti Mercury Autocode performing the solution is described. Calculated equivalent parameters for control rods in a heavy water lattice are given for some representative cases.

A Randomized Control Study on Psycho-Education Group on Improving Health-Related Quality of Life of Chinese Persons with Major Neurocognitive Disorder.

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Young, Kim-Wan

2016-01-01

People with a major neurocognitive disorder (PwND) are found to have a lower health related quality of life (HRQoL) than those without neurocognitive disorder. This research study aims to evaluate the effectiveness of a psycho-education group in improving the HRQoL of Chinese PwND. By adopting randomized control trial (RCT), Chinese PwND were randomly assigned to either a 10-session psycho-education group or the control group. Family caregivers of treatment group were encouraged to take part in two sessions focusing on the caring and communication skills. Control group and their family caregivers received standardized educational materials on basic information on neurocognitive disorder for them to read at home. Standardized assessment was conducted both with PwND and their caregivers independently to give the self-rated and caregiver-rated HRQoL of PwND in the pre- and post- treatment periods by a research assistant who was blind to the group assignment of the participants. Moreover, qualitative interviews were also conducted for ten participants and five family caregivers of the treatment group to identify those group elements relating to its effectiveness. 2 × 2 repeated measures ANCOVA demonstrated that the treatment group (n = 32) was significantly more effective than the control group (n = 32) in improving the caregiver-rated HRQoL (F[1, 61] = 4.35, p = .04 psycho-education group significantly improves caregiver-rated HRQoL of PwND, supporting the feasibility and effectiveness of the psycho-education group.

Integrating CHWs as part of the team leading diabetes group visits: A randomized controlled feasibility study

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The purpose of the study was to evaluate the feasibility of integrating Community Health Workers (CHWs) as part of the team leading diabetes group visits. This was a randomized controlled study that integrated CHWs as part of the team leading diabetes group visits for low-income Hispanic adults (n=5...

Mobile Phone Apps for University Students With Hazardous Alcohol Use: Study Protocol for Two Consecutive Randomized Controlled Trials.

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Berman, Anne H; Gajecki, Mikael; Fredriksson, Morgan; Sinadinovic, Kristina; Andersson, Claes

2015-12-22

About 50% of university students overconsume alcohol, and drinking habits in later adulthood are to some extent established during higher educational studies. Several studies have demonstrated that Internet-based interventions have positive effects on drinking habits among university students. Our recent study evaluated two mobile phone apps targeting drinking choices at party occasions via personalized feedback on estimated blood alcohol concentration (eBAC) for students with hazardous drinking. No changes in drinking parameters were found over a seven-week period apart from an increase in number of drinking occasions among men for one of the apps tested. Up to 30% of the study participants drank at potentially harmful levels: higher than the national recommended number of standard drinks per week (a maximum of 9 for women and 14 for men) in Sweden. (1) To evaluate improved versions of the two mobile phone apps tested in our prior trial, in a new, 3-armed randomized controlled trial among university students with at least hazardous drinking habits according to the Alcohol Use Disorders Identifications Test (AUDIT; Study 1). (2) After 6 weeks, to target study participants showing alcohol consumption higher than the national recommended levels for standard drinks per week by offering them participation in a second, 2-armed randomized trial evaluating an additional mobile phone app with skill enhancement tasks (Study 2). (3) To follow participants at 6, 12 and 18 weeks after recruitment to Study 1 and at 6 and 12 weeks after recruitment to Study 2. Two randomized controlled trials are conducted. Study 1: Students are recruited at four Swedish universities, via direct e-mail and advertisements on Facebook and student union web sites. Those who provide informed consent, have a mobile phone, and show at least hazardous alcohol consumption according to the AUDIT (≥6 for women; ≥8 points for men) are randomized into three groups. Group 1 has access to the Swedish

Efficacy of group psychotherapy for social anxiety disorder: A meta-analysis of randomized-controlled trials.

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Barkowski, Sarah; Schwartze, Dominique; Strauss, Bernhard; Burlingame, Gary M; Barth, Jürgen; Rosendahl, Jenny

2016-04-01

Group psychotherapy for social anxiety disorder (SAD) is an established treatment supported by findings from primary studies and earlier meta-analyses. However, a comprehensive summary of the recent evidence is still pending. This meta-analysis investigates the efficacy of group psychotherapy for adult patients with SAD. A literature search identified 36 randomized-controlled trials examining 2171 patients. Available studies used mainly cognitive-behavioral group therapies (CBGT); therefore, quantitative analyses were done for CBGT. Medium to large positive effects emerged for wait list-controlled trials for specific symptomatology: g=0.84, 95% CI [0.72; 0.97] and general psychopathology: g=0.62, 95% CI [0.36; 0.89]. Group psychotherapy was also superior to common factor control conditions in alleviating symptoms of SAD, but not in improving general psychopathology. No differences appeared for direct comparisons of group psychotherapy and individual psychotherapy or pharmacotherapy. Hence, group psychotherapy for SAD is an efficacious treatment, equivalent to other treatment formats. Copyright © 2016 Elsevier Ltd. All rights reserved.

Electroacupuncture treatment for pancreatic cancer pain: a randomized controlled trial.

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Chen, Hao; Liu, Tang-Yi; Kuai, Le; Zhu, Ji; Wu, Cai-Jun; Liu, Lu-Ming

2013-01-01

Pancreatic cancer is often accompanied by severe abdominal or back pain. It's the first study to evaluate the analgesic effect of electroacupuncture on pancreatic cancer pain. A randomized controlled trial compared electroacupuncture with control acupuncture using the placebo needle. Sixty patients with pancreatic cancer pain were randomly assigned to the electroacupuncture group (n = 30) and the placebo control group (n = 30). Patients were treated on Jiaji (Ex-B2) points T8-T12 bilaterally for 30 min once a day for 3 days. Pain intensity was assessed with numerical rated scales (NRS) before the treatment (Baseline), after 3 treatments, and 2 days follow-up. Baseline characteristics were similar in the two groups. After 3 treatment, pain intensity on NRS decreased compared with Baseline (-1.67, 95% confidence interval [CI] -1.46 to -1.87) in the electroacupuncture group; there was little change (-0.13, 95% CI 0.08 to -0.35) in control group; the difference between two groups was statistically significant (P electroacupuncture group compared with the control group (P Electroacupuncture was an effective treatment for relieving pancreatic cancer pain. Copyright © 2013 IAP and EPC. Published by Elsevier B.V. All rights reserved.

Behavioral insights and business taxation: Evidence from two randomized controlled trials

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Biddle, Nicholas; Fels, Katja; Sinning, Mathias

2017-01-01

This paper presents the findings of two Randomized Controlled Trials (RCTs) that were conducted in collaboration with the Australian Taxation Office (ATO). The first trial tests the effect of changes to letters (timing, social norms, color, and provision of information about charitable donations) on response rates of businesses, the timing of payments and the amount of tax debt payments. The second trial consists of two parts. The first part aims to raise awareness of the relevance of tax deb...

Targeting young drinkers online: the effectiveness of a web-based brief alcohol intervention in reducing heavy drinking among college students: study protocol of a two-arm parallel group randomized controlled trial

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Lemmers Lex ACJ

2011-04-01

Full Text Available Abstract Background The prevalence of heavy drinking among college students and its associated health related consequences highlights an urgent need for alcohol prevention programs targeting 18 to 24 year olds. Nevertheless, current alcohol prevention programs in the Netherlands pay surprisingly little attention to the drinking patterns of this specific age group. The study described in this protocol will test the effectiveness of a web-based brief alcohol intervention that is aimed at reducing alcohol use among heavy drinking college students aged 18 to 24 years old. Methods/Design The effectiveness of the What Do You Drink web-based brief alcohol intervention will be tested among 908 heavy drinking college students in a two-arm parallel group randomized controlled trial. Participants will be allocated at random to either the experimental (N = 454: web-based brief alcohol intervention or control condition (N = 454: no intervention. The primary outcome measure will be the percentage of participants who drink within the normative limits of the Dutch National Health Council for low-risk drinking. These limits specify that, for heavy alcohol use, the mean consumption cannot exceed 14 or 21 glasses of standard alcohol units per week for females and males, respectively, while for binge drinking, the consumption cannot exceed five or more glasses of standard alcohol units on one drinking occasion at least once per week within one month and six months after the intervention. Reductions in mean weekly alcohol consumption and frequency of binge drinking are also primary outcome measures. Weekly Ecological Momentary Assessment will measure alcohol-related cognitions, that is, attitudes, self-efficacy, subjective norms and alcohol expectancies, which will be included as the secondary outcome measures. Discussion This study protocol describes the two-arm parallel group randomized controlled trial developed to evaluate the effectiveness of a web-based brief

The Effect of Group Discussion-based Education on Self-management of Adults with Type 2 Diabetes Mellitus Compared with Usual Care: A Randomized Control Trial

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Hosein Habibzadeh

2017-11-01

Full Text Available Objectives: We sought to determine the effect of group discussion-based education on the self-management capability of patients with type 2 diabetes in Iran. Methods: This randomized control trial was conducted on 90 patients with type 2 diabetes. Participants were allocated randomly into one of two groups; intervention and control. The intervention group received the group discussion-based education while the control group received routine care only. The Lin’s self-management questionnaire was completed at baseline and three months post-intervention. Results: Statistical analysis, including the use of independent t-test, identified that in comparison to the control group, significant increases were observed in the scores of self-organization (t =11.24, p < 0.001, self-adjustment (t = 7.53, p < 0.001, interaction with health experts (t = 7.31, p < 0.001, blood sugar self-monitoring (t = 6.42, p < 0.001, adherence to the proposed diet (t = 5.22, p < 0.001, and total self-management (t = 10.82, p < 0.001 in the intervention group. Conclusions: Sharing experiences through group discussions and receiving instructive feedback can improve the ability to self-manage diabetes.

Effectiveness of group reminiscence for improving wellbeing of institutionalized elderly adults: study protocol for a randomized controlled trial.

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Gaggioli, Andrea; Scaratti, Chiara; Morganti, Luca; Stramba-Badiale, Marco; Agostoni, Monica; Spatola, Chiara A M; Molinari, Enrico; Cipresso, Pietro; Riva, Giuseppe

2014-10-25

Group reminiscence therapy is a brief and structured intervention in which participants share personal past events with peers. This approach has been shown to be promising for improving wellbeing and reducing depressive symptoms among institutionalized older adults. However, despite the considerable interest in reminiscence group therapy, controlled studies to determine its specific benefits as compared to generic social interactions with peers (group conversations about everyday subjects) are still lacking. We have designed a randomized controlled trial aimed at comparing the effects of group reminiscence therapy with those of group recreational activity on the psychological wellbeing of an institutionalized sample of older adults. The study includes two groups of 20 hospitalized elderly participants: the experimental group and the control group. Participants included in the experimental group will receive six sessions of group reminiscence therapy, while the control group will participate in a recreational group discussion. A repeated-measures design will be used post-intervention and three months post-intervention to evaluate changes in self-reported outcome measures of depressive symptoms, self-esteem, life satisfaction, and quality of life from baseline. The protocol of a study aimed at examining the specific effects of group reminiscence therapy on psychological wellbeing, depression, and quality of life among institutionalized elderly people is described. It is expected that the outcomes of this trial will contribute to our knowledge about the process of group reminiscence, evaluate its effectiveness in improving psychological wellbeing of institutionalized individuals, and identify the best conditions for optimizing this approach. This trial was registered with ClinicalTrials.gov (registration number: NCT02077153) on 31 January 2014.

Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial

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Mash Bob

2012-12-01

Full Text Available Abstract Background Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Methods Trial design: Pragmatic cluster randomized controlled trial Participants: Type 2 diabetic patients attending 45 public sector community health centres in Cape Town Interventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. Objective: To evaluate the effectiveness of the group diabetes education programme Outcomes: Primary outcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. Secondary outcomes: self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of life Randomisation: Computer generated random numbers Blinding: Patients, health promoters and research assistants could not be blinded to the health centre’s allocation Numbers randomized: Seventeen health centres (34 in total will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. Discussion The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can

Effects of supportive-expressive discussion groups on loneliness, hope and quality of life in breast cancer survivors: a randomized control trial.

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Tabrizi, Fatemeh Moghaddam; Radfar, Moloud; Taei, Zeynab

2016-09-01

Evaluation of the effect of supportive expressive discussion groups on loneliness, hope and quality of life in breast cancer survivors. A randomized control trial including breast cancer patients who had completed chemotherapy and randomly allocated into two groups: intervention (n = 41) and control (n = 40). The intervention consisted of twelve weekly 90-min sessions for groups of six to eight breast cancer survivors. Data were obtained pre-to -post the intervention and at 8-week follow-up. The data were analyzed using a repeated-measures analysis of variance (ANOVA). The findings revealed a significant reduction in loneliness scores (F = 69.85, p hope (F = 20.8, p life from pre- to post-intervention, and then over the 8-week follow-up period in the intervention group, while scores of control participants did not show this pattern during the study. The strongest effects were found for global quality of life (effect size) = 0.59), for future perspectives (effect size = 0.51), emotional functioning (effect size = 0.35) and social functioning (effect size = 0.31). The intervention was effective on loneliness, hope and quality of life in the intervention group. The intervention needs further evaluation in a larger study and with other cancer types. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Effects of gut-directed hypnotherapy on IBS in different clinical settings-results from two randomized, controlled trials.

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Lindfors, Perjohan; Unge, Peter; Arvidsson, Patrik; Nyhlin, Henry; Björnsson, Einar; Abrahamsson, Hasse; Simrén, Magnus

2012-02-01

Gut-directed hypnotherapy has been found to be effective in irritable bowel syndrome (IBS). However, randomized, controlled studies are rare and few have been performed outside highly specialized research centers. The objective of this study was to study the effect of gut-directed hypnotherapy in IBS in different clinical settings outside the traditional research units. The study population included IBS patients refractory to standard management. In study 1, patients were randomized to receive gut-directed hypnotherapy (12 sessions, 1 h/week) in psychology private practices or supportive therapy, whereas patients were randomized to receive gut-directed hypnotherapy in a small county hospital or to serve as waiting list controls in study 2. Gastrointestinal symptom severity and quality of life were evaluated at baseline, at 3 months follow-up and after 1 year. We randomized 138 IBS patients refractory to standard management, 90 in study 1 and 48 in study 2. In both the studies, IBS-related symptoms were improved at 3 months in the gut-directed hypnotherapy groups (Phypnotherapy group than in the control group (Phypnotherapy is an effective treatment alternative for patients with refractory IBS, but the effectiveness is lower when the therapy is given outside the highly specialized research centers.

Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial

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Kahn, Susan R.; Shrier, Ian; Shapiro, Stan; Houweling, Adrielle H.; Hirsch, Andrew M.; Reid, Robert D.; Kearon, Clive; Rabhi, Khalil; Rodger, Marc A.; Kovacs, Michael J.; Anderson, David R.; Wells, Philip S.

2011-01-01

Background Exercise training may have the potential to improve post-thrombotic syndrome, a frequent, chronic complication of deep venous thrombosis. We conducted a randomized controlled two-centre pilot trial to assess the feasibility of a multicentre-based evaluation of a six-month exercise training program to treat post-thrombotic syndrome and to obtain preliminary data on the effectiveness of such a program. Methods Patients were randomized to receive exercise training (a six-month trainer-supervised program) or control treatment (an education session with monthly phone follow-ups). Levels of eligibility, consent, adherence and retention were used as indicators of study feasibility. Primary outcomes were change from baseline to six months in venous disease-specific quality of life (as measured using the Venous Insufficiency Epidemiological and Economic Study Quality of Life [VEINES-QOL] questionnaire) and severity of post-thrombotic syndrome (as measured by scores on the Villalta scale) in the exercise training group versus the control group, assessed by t tests. Secondary outcomes were change in generic quality of life (as measured using the Short-Form Health Survey-36 [SF-36] questionnaire), category of severity of post-thrombotic syndrome, leg strength, leg flexibility and time on treadmill. Results Of 95 patients with post-thrombotic syndrome, 69 were eligible, 43 consented and were randomized, and 39 completed the study. Exercise training was associated with improvement in VEINES-QOL scores (exercise training mean change 6.0, standard deviation [SD] 5.1 v. control mean change 1.4, SD 7.2; difference 4.6, 95% CI 0.54 to 8.7; p = 0.027) and improvement in scores on the Villalta scale (exercise training mean change −3.6, SD 3.7 v. control mean change −1.6, SD 4.3; difference −2.0, 95% CI −4.6 to 0.6; p = 0.14). Most secondary outcomes also showed greater improvement in the exercise training group. Interpretation Exercise training may improve post

A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol

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Sophia I. Allen

2017-01-01

Full Text Available Abstract Background The U.S. Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content. Such a standard should improve public health without causing unintended serious consequences for sub-populations. This study evaluates the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders using a two-site, two-arm, double-blind, parallel group, randomized controlled trial (RCT in four phases over 34 weeks. Methods Adult smokers (N = 200 of 5 or more cigarettes per day will be randomized across two sites (Penn State and Massachusetts General. Participants must have not had a quit attempt in the prior month, nor be planning to quit in the next 6 months, meet criteria for a current or lifetime unipolar mood and/or anxiety disorder based on the structured Mini-International Neuropsychiatric Interview, and must not have an unstable medical or psychiatric condition. After a week of smoking their own cigarettes, participants receive two weeks of Spectrum research cigarettes with usual nicotine content (11.6 mg. After this baseline period, participants will be randomly assigned to continue smoking Spectrum research cigarettes that contain either (a Usual Nicotine Content (11.6 mg; or (b Reduced Nicotine Content: the nicotine content per cigarette is progressively reduced from approximately 11.6 mg to 0.2 mg in five steps over 18 weeks. At the end of the randomization phase, participants will be offered the choice to either (a quit smoking with assistance, (b continue smoking free research cigarettes, or (c return to purchasing their own cigarettes, for the final 12 weeks of the study. The primary outcome measure is blood cotinine; key secondary outcomes are: exhaled carbon monoxide, urinary total NNAL- 4-(methylnitrosamino-1-(3-pyridyl-1-butanol and 1-hydroxypyrene, oxidative

Sample size determinations for group-based randomized clinical trials with different levels of data hierarchy between experimental and control arms.

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Heo, Moonseong; Litwin, Alain H; Blackstock, Oni; Kim, Namhee; Arnsten, Julia H

2017-02-01

We derived sample size formulae for detecting main effects in group-based randomized clinical trials with different levels of data hierarchy between experimental and control arms. Such designs are necessary when experimental interventions need to be administered to groups of subjects whereas control conditions need to be administered to individual subjects. This type of trial, often referred to as a partially nested or partially clustered design, has been implemented for management of chronic diseases such as diabetes and is beginning to emerge more commonly in wider clinical settings. Depending on the research setting, the level of hierarchy of data structure for the experimental arm can be three or two, whereas that for the control arm is two or one. Such different levels of data hierarchy assume correlation structures of outcomes that are different between arms, regardless of whether research settings require two or three level data structure for the experimental arm. Therefore, the different correlations should be taken into account for statistical modeling and for sample size determinations. To this end, we considered mixed-effects linear models with different correlation structures between experimental and control arms to theoretically derive and empirically validate the sample size formulae with simulation studies.

A Randomized Controlled Trial of Two Different Macronutrient Profiles on Weight, Body Composition and Metabolic Parameters in Obese Adolescents Seeking Weight Loss.

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Helen Truby

Full Text Available Adolescent obesity is difficult to treat and the optimal dietary pattern, particularly in relation to macronutrient composition, remains controversial. This study tested the effect of two structured diets with differing macronutrient composition versus control, on weight, body composition and metabolic parameters in obese adolescents.A randomized controlled trial conducted in a children's hospital.Eighty seven obese youth (means: age 13.6 years, BMI z-score 2.2, waist: height ratio 0.65, 69% female completed a psychological preparedness program and were then randomized to a short term 'structured modified carbohydrate' (SMC, 35% carbohydrate; 30% protein; 35% fat, n = 37 or a 'structured low fat' (SLF, 55% carbohydrate; 20% protein; 25% fat, n = 36 or a wait listed control group (n = 14. Anthropometric, body composition and biochemical parameters were measured at randomization and after 12 weeks, and analyzed under the intention to treat principle using analysis of variance models.After 12 weeks, data was collected from 79 (91% participants. BMI z-scores were significantly lower in both intervention groups compared to control after adjusting for baseline values, SLF vs. control, mean difference = -0.13 (95%CI = -0.18, -0.07, P<0.001; SMC vs. control, -0.14 (-0.19, -0.09, P<0.001, but there was no difference between the two intervention diet groups: SLF vs. SMC, 0.00 (-0.05, 0.04, P = 0.83.Both dietary patterns resulted in similar changes in weight, body composition and metabolic improvements compared to control. The use of a structured eating system which allows flexibility but limited choices can assist in weight change and the rigid application of a low fat eating pattern is not exclusive in its efficacy.International Clinical Trials Registry ISRCTN49438757.

Headache : The placebo effects in the control groups in randomized clinical trials; An analysis of systematic reviews

NARCIS (Netherlands)

de Groot, Femke M.; Voogt-Bode, Annieke; Passchier, Jan; Berger, Marjolein Y.; Koes, Bart W.; Verhagen, Arianne P.

Objective: The purpose of this study is to describe the effects in the placebo and "no treatment" arms in trials with headache patients. Method: This is a secondary analysis of randomized controlled trials from 8 systematic reviews and selected trials with a "no treatment" or placebo control group.

Two-year impact of community-based health screening and parenting groups on child development in Zambia: Follow-up to a cluster-randomized controlled trial.

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Rockers, Peter C; Zanolini, Arianna; Banda, Bowen; Chipili, Mwaba Moono; Hughes, Robert C; Hamer, Davidson H; Fink, Günther

2018-04-01

Early childhood interventions have potential to offset the negative impact of early adversity. We evaluated the impact of a community-based parenting group intervention on child development in Zambia. We conducted a non-masked cluster-randomized controlled trial in Southern Province, Zambia. Thirty clusters of villages were matched based on population density and distance from the nearest health center, and randomly assigned to intervention (15 clusters, 268 caregiver-child dyads) or control (15 clusters, 258 caregiver-child dyads). Caregivers were eligible if they had a child 6 to 12 months old at baseline. In intervention clusters, caregivers were visited twice per month during the first year of the study by child development agents (CDAs) and were invited to attend fortnightly parenting group meetings. Parenting groups selected "head mothers" from their communities who were trained by CDAs to facilitate meetings and deliver a diverse parenting curriculum. The parenting group intervention, originally designed to run for 1 year, was extended, and households were visited for a follow-up assessment at the end of year 2. The control group did not receive any intervention. Intention-to-treat analysis was performed for primary outcomes measured at the year 2 follow-up: stunting and 5 domains of neurocognitive development measured using the Bayley Scales of Infant and Toddler Development-Third Edition (BSID-III). In order to show Cohen's d estimates, BSID-III composite scores were converted to z-scores by standardizing within the study population. In all, 195/268 children (73%) in the intervention group and 182/258 children (71%) in the control group were assessed at endline after 2 years. The intervention significantly reduced stunting (56/195 versus 72/182; adjusted odds ratio 0.45, 95% CI 0.22 to 0.92; p = 0.028) and had a significant positive impact on language (β 0.14, 95% CI 0.01 to 0.27; p = 0.039). The intervention did not significantly impact cognition (β 0

Two-year impact of community-based health screening and parenting groups on child development in Zambia: Follow-up to a cluster-randomized controlled trial.

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Peter C Rockers

2018-04-01

Full Text Available Early childhood interventions have potential to offset the negative impact of early adversity. We evaluated the impact of a community-based parenting group intervention on child development in Zambia.We conducted a non-masked cluster-randomized controlled trial in Southern Province, Zambia. Thirty clusters of villages were matched based on population density and distance from the nearest health center, and randomly assigned to intervention (15 clusters, 268 caregiver-child dyads or control (15 clusters, 258 caregiver-child dyads. Caregivers were eligible if they had a child 6 to 12 months old at baseline. In intervention clusters, caregivers were visited twice per month during the first year of the study by child development agents (CDAs and were invited to attend fortnightly parenting group meetings. Parenting groups selected "head mothers" from their communities who were trained by CDAs to facilitate meetings and deliver a diverse parenting curriculum. The parenting group intervention, originally designed to run for 1 year, was extended, and households were visited for a follow-up assessment at the end of year 2. The control group did not receive any intervention. Intention-to-treat analysis was performed for primary outcomes measured at the year 2 follow-up: stunting and 5 domains of neurocognitive development measured using the Bayley Scales of Infant and Toddler Development-Third Edition (BSID-III. In order to show Cohen's d estimates, BSID-III composite scores were converted to z-scores by standardizing within the study population. In all, 195/268 children (73% in the intervention group and 182/258 children (71% in the control group were assessed at endline after 2 years. The intervention significantly reduced stunting (56/195 versus 72/182; adjusted odds ratio 0.45, 95% CI 0.22 to 0.92; p = 0.028 and had a significant positive impact on language (β 0.14, 95% CI 0.01 to 0.27; p = 0.039. The intervention did not significantly impact

Treatment of posttraumatic stress disorder in postwar Kosovar adolescents using mind-body skills groups: a randomized controlled trial.

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Gordon, James S; Staples, Julie K; Blyta, Afrim; Bytyqi, Murat; Wilson, Amy T

2008-09-01

To determine whether participation in a mind-body skills group program based on psychological self-care, mind-body techniques, and self-expression decreases symptoms of posttraumatic stress disorder (PTSD). Eighty-two adolescents meeting criteria for PTSD according to the Harvard Trauma Questionnaire (which corresponds with 16 of the 17 diagnostic criteria for PTSD in DSM-IV) were randomly assigned to a 12-session mind-body group program or a wait-list control group. The program was conducted by high school teachers in consultation with psychiatrists and psychologists and included meditation, guided imagery, and breathing techniques; self-expression through words, drawings, and movement; autogenic training and biofeedback; and genograms. Changes in PTSD symptoms were measured using the Harvard Trauma Questionnaire. The study was conducted from September 2004 to May 2005 by The Center for Mind-Body Medicine at a high school in the Suhareka region of Kosovo. Students in the immediate intervention group had significantly lower PTSD symptom scores following the intervention than those in the wait-list control group (F = 29.8, df = 1,76; p control group, 2.5 (0.3) and 2.4 (0.4), respectively. The decreased PTSD symptom scores were maintained in the initial intervention group at 3-month follow-up. After the wait-list control group received the intervention, there was a significant decrease (p Mind-body skills groups can reduce PTSD symptoms in war-traumatized high school students and can be effectively led by trained and supervised schoolteachers. Copyright 2008 Physicians Postgraduate Press, Inc.

Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

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Nuria eRuffini

2015-08-01

Full Text Available Context: Heart Rate Variability (HRV indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT on ANS activity through changes of High Frequency, a heart rate variability index indicating the parasympathetic activity, in healthy subjects, compared with sham therapy and control group.Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults, both smokers and non-smokers and not on medications. At enrollment subjects were randomized in 3 groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920.Main Outcomes Measures: HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 minutes.Results: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency rate (p<0.001, and decrease of sympathetic activity, as revealed by Low Frequency rate (p<0.01; results also showed a reduction of Low Frequency/High Frequency ratio (p<0.001 and Detrended fluctuation scaling exponent (p<0.05. Conclusions: Findings suggested that OMT can influence ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group.

Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery.

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Shepherd, Deborah M; Jahnke, Heidi; White, William L; Little, Andrew S

2018-02-01

OBJECTIVE Pain control is an important clinical consideration and quality-of-care metric. No studies have examined postoperative pain control following transsphenoidal surgery for pituitary lesions. The study goals were to 1) report postoperative pain scores following transsphenoidal surgery, 2) determine if multimodal opioid-minimizing pain regimens yielded satisfactory postoperative pain control, and 3) determine if intravenous (IV) ibuprofen improved postoperative pain scores and reduced opioid use compared with placebo. METHODS This study was a single-center, randomized, double-blinded, placebo-controlled intervention trial involving adult patients with planned transsphenoidal surgery for pituitary tumors randomized into 2 groups. Group 1 patients were treated with scheduled IV ibuprofen, scheduled oral acetaminophen, and rescue opioids. Group 2 patients were treated with IV placebo, scheduled oral acetaminophen, and rescue opioids. The primary end point was patient pain scores (visual analog scale [VAS], rated 0-10) for 48 hours after surgery. The secondary end point was opioid use as estimated by oral morphine equivalents (OMEs). RESULTS Of 136 patients screened, 62 were enrolled (28 in Group 1, 34 in Group 2). The study was terminated early because the primary and secondary end points were reached. Baseline characteristics between groups were well matched except for age (Group 1, 59.3 ± 14.4 years; Group 2, 49.8 ± 16.2 years; p = 0.02). Mean VAS pain scores were significantly different, with a 43% reduction in Group 1 (1.7 ± 2.2) compared with Group 2 (3.0 ± 2.8; p transsphenoidal surgery. IV ibuprofen resulted in significantly improved pain scores and significantly decreased opioid use compared with placebo. Postoperative multimodal pain management, including a nonsteroidal antiinflammatory medication, should be considered after surgery to improve patient comfort and to limit opioid use. Clinical trial registration no.: NCT02351700 (clinicaltrials

Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial

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Li Ying

2012-07-01

Full Text Available Abstract Background Whether acupuncture is effective for patients with functional constipation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using acupuncture to treat functional constipation. Design A randomized, controlled, four-arm design, large-scale trial is currently undergoing in China. Seven hundred participants are randomly assigned to three acupuncture treatment groups and Mosapride Citrate control group in a 1:1:1:1 ratio. Participants in acupuncture groups receive 16 sessions of acupuncture treatment, and are followed up for a period of 9 weeks after randomization. The acupuncture groups are: (1 Back-Shu and Front-Mu acupoints of Large Intestine meridians (Shu-Mu points group; (2 He-Sea and Lower He-Sea acupoints of Large Intestine meridians (He points group; (3 Combining used Back-Shu, Front-Mu, He-Sea, and Lower He-Sea acupoints of Large Intestine meridians (Shu-Mu-He points group. The control group is Mosapride Citrate group. The primary outcome is frequency of defecation per week at the fourth week after randomization. The secondary outcomes include Bristol stool scale, the extent of difficulty during defecating, MOS 36-item Short Form health survey (SF-36, Self-Rating Anxiety Scale (SAS, and Self-rating Depression Scale (SDS. The first two of second outcomes are measured 1 week before randomization and 2, 4, and 8 weeks after randomization. Other second outcomes are measured 1 week before randomization and 2 and 4 weeks after randomization, but SF-36 is measured at randomization and 4 weeks after randomization. Discussion The result of this trial (which will be available in 2012 will confirm whether acupuncture is effective to treat functional constipation and whether traditional acupuncture theories play an important role in it. Trials registration Clinical Trials.gov NCT01411501

Controlling Chronic Diseases Through Evidence-Based Decision Making: A Group-Randomized Trial.

Science.gov (United States)

Brownson, Ross C; Allen, Peg; Jacob, Rebekah R; deRuyter, Anna; Lakshman, Meenakshi; Reis, Rodrigo S; Yan, Yan

2017-11-30

Although practitioners in state health departments are ideally positioned to implement evidence-based interventions, few studies have examined how to build their capacity to do so. The objective of this study was to explore how to increase the use of evidence-based decision-making processes at both the individual and organization levels. We conducted a 2-arm, group-randomized trial with baseline data collection and follow-up at 18 to 24 months. Twelve state health departments were paired and randomly assigned to intervention or control condition. In the 6 intervention states, a multiday training on evidence-based decision making was conducted from March 2014 through March 2015 along with a set of supplemental capacity-building activities. Individual-level outcomes were evidence-based decision making skills of public health practitioners; organization-level outcomes were access to research evidence and participatory decision making. Mixed analysis of covariance models was used to evaluate the intervention effect by accounting for the cluster randomized trial design. Analysis was performed from March through May 2017. Participation 18 to 24 months after initial training was 73.5%. In mixed models adjusted for participant and state characteristics, the intervention group improved significantly in the overall skill gap (P = .01) and in 6 skill areas. Among the 4 organizational variables, only access to evidence and skilled staff showed an intervention effect (P = .04). Tailored and active strategies are needed to build capacity at the individual and organization levels for evidence-based decision making. Our study suggests several dissemination interventions for consideration by leaders seeking to improve public health practice.

Integrating CHWs as Part of the Team Leading Diabetes Group Visits: A Randomized Controlled Feasibility Study.

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Vaughan, Elizabeth M; Johnston, Craig A; Cardenas, Victor J; Moreno, Jennette P; Foreyt, John P

2017-12-01

Purpose The purpose of the study was to evaluate the feasibility of integrating Community Health Workers (CHWs) as part of the team leading diabetes group visits. Methods This was a randomized controlled study that integrated CHWs as part of the team leading diabetes group visits for low-income Hispanic adults (n = 50). Group visits met for 3 hours each month for a 6-month duration. Main measures included baseline and 6-month clinical outcomes (ie, A1C, lipids), concordance with 8 standard of care guidelines (ie, screens for cervical, breast, and colon cancer) from the US Preventive Task Force and American Diabetes Association, and participant acceptability. Results Compared to control participants, the intervention group resulted in significantly better clinical outcomes or guideline concordance for the following areas: target A1C levels, retinal eye exams, diabetes foot exams, mammograms, and urine microalbumin. Significantly more individuals in the control group gained weight, whereas a greater number of participants in the intervention group lost weight. Intervention participants found the group visits highly acceptable. Conclusions Integrating CHWs as part a comprehensive diabetes group visit program is a feasible and effective system-level intervention to improve glycemic control and achieve guideline concordance.

Projection correlation between two random vectors.

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Zhu, Liping; Xu, Kai; Li, Runze; Zhong, Wei

2017-12-01

We propose the use of projection correlation to characterize dependence between two random vectors. Projection correlation has several appealing properties. It equals zero if and only if the two random vectors are independent, it is not sensitive to the dimensions of the two random vectors, it is invariant with respect to the group of orthogonal transformations, and its estimation is free of tuning parameters and does not require moment conditions on the random vectors. We show that the sample estimate of the projection correction is [Formula: see text]-consistent if the two random vectors are independent and root-[Formula: see text]-consistent otherwise. Monte Carlo simulation studies indicate that the projection correlation has higher power than the distance correlation and the ranks of distances in tests of independence, especially when the dimensions are relatively large or the moment conditions required by the distance correlation are violated.

Group versus Internet-based cognitive-behavioral therapy for procrastination: Study protocol for a randomized controlled trial

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Alexander Rozental

2014-04-01

Full Text Available Procrastination is defined as a voluntarily delay of an intended course of action despite expecting to be worse-off for the delay, and is considered a persistent behavior pattern that can result in major psychological suffering. About one-fifth of the adult population and half of the student population are presumed having substantial difficulties due to recurrent procrastination in their everyday lives. However, chronic and severe procrastinators seldom receive adequate care due to preconceptions and the lack of understanding regarding procrastination and the treatment interventions that are assumed beneficial. Cognitive-behavioral therapy is often deemed a treatment of choice, although the evidence supporting its use is scarce, and only one randomized controlled trial has been performed. The primary aim of the proposed study is therefore to test the efficacy of cognitive-behavioral therapy delivered as either a group intervention or via the Internet. Participants will consist of students recruited through the Student Health Centre at Karolinska Institutet. A randomized controlled trial with a sample size of 100 participants divided into blocks of thirty will be used, comparing an eight-week Internet-based cognitive-behavioral therapy intervention, and an eight-week group cognitive-behavioral therapy based intervention. It is believed that the proposed study will result in two important findings. First, different treatment interventions in cognitive-behavioral therapy are assumed to be helpful for people suffering from problems caused by procrastination. Second, both an Internet-based cognitive-behavioral therapy intervention and a group intervention are presumed suitable for administering treatment for procrastination, which is considered important as the availability of adequate care is limited, particularly among students. The proposed study will increase the knowledge regarding the efficacy of different treatments of procrastination, as well

Testing a stepped care model for binge-eating disorder: a two-step randomized controlled trial.

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Tasca, Giorgio A; Koszycki, Diana; Brugnera, Agostino; Chyurlia, Livia; Hammond, Nicole; Francis, Kylie; Ritchie, Kerri; Ivanova, Iryna; Proulx, Genevieve; Wilson, Brian; Beaulac, Julie; Bissada, Hany; Beasley, Erin; Mcquaid, Nancy; Grenon, Renee; Fortin-Langelier, Benjamin; Compare, Angelo; Balfour, Louise

2018-05-24

A stepped care approach involves patients first receiving low-intensity treatment followed by higher intensity treatment. This two-step randomized controlled trial investigated the efficacy of a sequential stepped care approach for the psychological treatment of binge-eating disorder (BED). In the first step, all participants with BED (n = 135) received unguided self-help (USH) based on a cognitive-behavioral therapy model. In the second step, participants who remained in the trial were randomized either to 16 weeks of group psychodynamic-interpersonal psychotherapy (GPIP) (n = 39) or to a no-treatment control condition (n = 46). Outcomes were assessed for USH in step 1, and then for step 2 up to 6-months post-treatment using multilevel regression slope discontinuity models. In the first step, USH resulted in large and statistically significant reductions in the frequency of binge eating. Statistically significant moderate to large reductions in eating disorder cognitions were also noted. In the second step, there was no difference in change in frequency of binge eating between GPIP and the control condition. Compared with controls, GPIP resulted in significant and large improvement in attachment avoidance and interpersonal problems. The findings indicated that a second step of a stepped care approach did not significantly reduce binge-eating symptoms beyond the effects of USH alone. The study provided some evidence for the second step potentially to reduce factors known to maintain binge eating in the long run, such as attachment avoidance and interpersonal problems.

Dynamic Output Feedback Control for Nonlinear Networked Control Systems with Random Packet Dropout and Random Delay

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Shuiqing Yu

2013-01-01

Full Text Available This paper investigates the dynamic output feedback control for nonlinear networked control systems with both random packet dropout and random delay. Random packet dropout and random delay are modeled as two independent random variables. An observer-based dynamic output feedback controller is designed based upon the Lyapunov theory. The quantitative relationship of the dropout rate, transition probability matrix, and nonlinear level is derived by solving a set of linear matrix inequalities. Finally, an example is presented to illustrate the effectiveness of the proposed method.

The Effectiveness of a Group Triple P with Chinese Parents Who Have a Child with Developmental Disabilities: A Randomized Controlled Trial

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Leung, Cynthia; Fan, Angel; Sanders, Matthew R.

2013-01-01

The study examined the effectiveness of Group Triple P, a Level 4 variant of the Triple P multilevel system of parenting support, with Chinese parents who had a preschool aged child with a developmental disability, using randomized controlled trial design. Participants (Intervention group: 42; Waitlist Control group: 39) completed measures on…

Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.

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Patricia Bourgault

Full Text Available This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS.A mixed-methods randomized controlled trial (intervention (INT vs. waitlist (WL was conducted with patients suffering from FMS. Data were collected at baseline (T0, at the end of the intervention (T1, and 3 months later (T2. The primary outcome was change in pain intensity (0-10. Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC, and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients.The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively than in the WL Group (8%, 12%, 20%. The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%. The proportion of patients who reported ≥ 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12% and 3 months post-intervention (33% vs 4%. Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures.The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience.International Standard Randomized Controlled Trial Number

The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study - a randomized controlled trial

DEFF Research Database (Denmark)

Toft, Ulla; Kristoffersen, Lis; Ladelund, Steen

2008-01-01

in dietary habits. METHODS: The study was a randomized controlled intervention study. From a general Danish population, aged 30 to 60 years (n = 61,301), two random sample were drawn (group A, n = 11,708; group B, n = 1,308). Subjects were invited for a health screening program. Participation rate was 52...... participants were invited for a health examination. High risk individuals were included in this study (n = 2 356) and changes in dietary intake were analyzed using multilevel linear regression analyses. RESULTS: At one-year follow-up group A had significantly increased the unsaturated/saturated fat ratio...... compared to group B and in men a significantly greater decrease in saturated fat intake was found in group A compared to group B (net change: -1.13 E%; P = 0.003). No differences were found between group A and B at three-year follow-up. At five-year follow-up group A had significantly increased...

A randomized controlled trial of group Stepping Stones Triple P: a mixed-disability trial.

Science.gov (United States)

Roux, Gemma; Sofronoff, Kate; Sanders, Matthew

2013-09-01

Stepping Stones Triple P (SSTP) is a parenting program designed for families of a child with a disability. The current study involved a randomized controlled trial of Group Stepping Stones Triple P (GSSTP) for a mixed-disability group. Participants were 52 families of children diagnosed with an Autism Spectrum Disorder, Down syndrome, Cerebral Palsy, or an intellectual disability. The results demonstrated significant improvements in parent-reported child behavior, parenting styles, parental satisfaction, and conflict about parenting. Results among participants were similar despite children's differing impairments. The intervention effect was maintained at 6-month follow-up. The results indicate that GSSTP is a promising intervention for a mixed-disability group. Limitations of the study, along with areas for future research, are also discussed. © FPI, Inc.

A national study of the psychological impact of bank robbery with a randomized control group

DEFF Research Database (Denmark)

Hansen, Maj; Armour, Cherie; Shevlin, Mark

of bank employees exposed to robbery (response rate: 73.6 %). Several related factors were also investigated including prior traumatic exposure, anxiety, and general traumatic symptoms. The results were compared to a randomized control group of bank employees never exposed to robbery (N= 303...... but surprisingly significantly higher than the follow-up robbery group. The results are discussed in relation to existing research and the effect of other factors such as prior traumatic exposure. In conclusion bank robberies are a traumatizing event for the employees, especially when disregarding avoidance...

Experience with multiple control groups in a large population-based case-control study on genetic and environmental risk factors.

Science.gov (United States)

Pomp, E R; Van Stralen, K J; Le Cessie, S; Vandenbroucke, J P; Rosendaal, F R; Doggen, C J M

2010-07-01

We discuss the analytic and practical considerations in a large case-control study that had two control groups; the first control group consisting of partners of patients and the second obtained by random digit dialling (RDD). As an example of the evaluation of a general lifestyle factor, we present body mass index (BMI). Both control groups had lower BMIs than the patients. The distribution in the partner controls was closer to that of the patients, likely due to similar lifestyles. A statistical approach was used to pool the results of both analyses, wherein partners were analyzed with a matched analysis, while RDDs were analyzed without matching. Even with a matched analysis, the odds ratio with partner controls remained closer to unity than with RDD controls, which is probably due to unmeasured confounders in the comparison with the random controls as well as intermediary factors. However, when studying injuries as a risk factor, the odds ratio remained higher with partner control subjects than with RRD control subjects, even after taking the matching into account. Finally we used factor V Leiden as an example of a genetic risk factor. The frequencies of factor V Leiden were identical in both control groups, indicating that for the analyses of this genetic risk factor the two control groups could be combined in a single unmatched analysis. In conclusion, the effect measures with the two control groups were in the same direction, and of the same order of magnitude. Moreover, it was not always the same control group that produced the higher or lower estimates, and a matched analysis did not remedy the differences. Our experience with the intricacies of dealing with two control groups may be useful to others when thinking about an optimal research design or the best statistical approach.

A cognitive behavioral based group intervention for children with a chronic illness and their parents: a multicentre randomized controlled trial

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Schuengel Carlo

2011-07-01

Full Text Available Abstract Background Coping with a chronic illness (CI challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called 'Op Koers' 1 for children with CI and of a parallel intervention for their parents. A secondary objective is to investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect. Methods/design This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population. Discussion This study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed

Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

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Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

2015-01-01

Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

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Gomes, Evelim L F D; Carvalho, Celso R F; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

2015-01-01

The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation. Clinicaltrials.gov NCT01438294.

Worksite Environmental Interventions for Obesity Prevention and Control: Evidence from Group Randomized Trials.

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Fernandez, Isabel Diana; Becerra, Adan; Chin, Nancy P

2014-06-01

Worksites provide multiple advantages to prevent and treat obesity and to test environmental interventions to tackle its multiple causal factors. We present a literature review of group-randomized and non-randomized trials that tested worksite environmental, multiple component interventions for obesity prevention and control paying particular attention to the conduct of formative research prior to intervention development. The evidence on environmental interventions on measures of obesity appears to be strong since most of the studies have a low (4/8) and unclear (2/8) risk of bias. Among the studies reviewed whose potential risk of bias was low, the magnitude of the effect was modest and sometimes in the unexpected direction. None of the four studies describing an explicit formative research stage with clear integration of findings into the intervention was able to demonstrate an effect on the main outcome of interest. We present alternative explanation for the findings and recommendations for future research.

Effectiveness of a group-based intervention to change medication beliefs and improve medication adherence in patients with rheumatoid arthritis: a randomized controlled trial.

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Zwikker, Hanneke E; van den Ende, Cornelia H; van Lankveld, Wim G; den Broeder, Alfons A; van den Hoogen, Frank H; van de Mosselaar, Birgit; van Dulmen, Sandra; van den Bemt, Bart J

2014-03-01

To assess the effect of a group-based intervention on the balance between necessity beliefs and concern beliefs about medication and on medication non-adherence in patients with rheumatoid arthritis (RA). Non-adherent RA patients using disease-modifying anti-rheumatic drugs (DMARDs) were randomized to an intervention or control arm. The intervention consisted, amongst others, of two motivational interviewing-guided group sessions led by the same pharmacist. Control patients received brochures about their DMARDs. Questionnaires were completed up to 12 months follow-up. 123 patients (mean age: 60 years, female: 69%) were randomized. No differences in necessity beliefs and concern beliefs about medication and in medication non-adherence were detected between the intervention and control arm, except at 12 months' follow-up: participants in the intervention arm had less strong necessity beliefs about medication than participants in the control arm (b: -1.0 (95% CI: -2.0, -0.1)). This trial did not demonstrate superiority of our intervention over the control arm in changing beliefs about medication or in improving medication adherence over time. Absent intervention effects might have been due to, amongst others, selection bias and a suboptimal treatment integrity level. Hence, targeting beliefs about medication in clinical practice should not yet be ruled out. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

A single blind randomized control trial on support groups for Chinese persons with mild dementia

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Young DKW

2014-12-01

Full Text Available Daniel KW Young,1 Timothy CY Kwok,2 Petrus YN Ng1 1Department of Social Work, Hong Kong Baptist University, Kowloon Tong, Hong Kong; 2Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong Purpose: Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Research methods: Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. Results: At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59% of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48 to 7.35 (standard deviation =2.18, which was significant (Wilcoxon signed-rank test; P=0.017, P<0.05, while the control group’s participants did not show any significant change. Conclusion: This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants. Keywords: support group, mild dementia, Chinese, depression

Comparison between group and personal rehabilitation for dementia in a geriatric health service facility: single-blinded randomized controlled study.

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Tanaka, Shigeya; Honda, Shin; Nakano, Hajime; Sato, Yuko; Araya, Kazufumi; Yamaguchi, Haruyasu

2017-05-01

The aim of this study was to compare the effects of rehabilitation involving group and personal sessions on demented participants. This single-blinded randomized controlled trial included 60 elderly participants with dementia in a geriatric health service facility, or R oken. Staff members, who did not participate in the intervention, examined cognitive function, mood, communication ability, severity of dementia, objective quality of life, vitality, and daily behaviour. After a baseline assessment, participants were randomly divided into three groups: (i) group intervention; (ii) personal intervention; and (iii) control. The 1-h group intervention (3-5 subjects) and 20-min personal intervention (one staff member per participant) were performed twice a week for 12 weeks (24 total sessions). The cognitive rehabilitation programme consisted of reminiscence, reality orientation, and physical exercise, and it was based on five principles of brain-activating rehabilitation; (i) pleasant atmosphere; (ii) communication; (iii) social roles; (iv) praising; and (v) errorless support. Data were analyzed after the second assessment. Outcome measures were analyzed in 43 participants-14 in the control group, 13 in group intervention, and 16 in personal intervention. Repeated measure ancova showed a significant interaction for cognitive function score (Mini-Mental State Examination) between group intervention and controls ( F  = 5.535, P = 0.029). In the post-hoc analysis, group intervention showed significant improvement (P = 0.016). Global severity of dementia tended to improve (P = 0.094) in group intervention compared to control (Mann-Whitney U -test). There were no significant interactions or improvements for other measurements. Group rehabilitation for dementia is more effective for improving cognitive function and global severity of dementia than personal rehabilitation in Roken. © 2016 Japanese Psychogeriatric Society.

Early functional outcome of two different orthotic concepts in ankle sprains: a randomized controlled trial.

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Best, Raymond; Böhle, Caroline; Schiffer, Thorsten; Petersen, Wolf; Ellermann, Andree; Brueggemann, Gert Peter; Liebau, Christian

2015-07-01

Purpose of the study was the evaluation of the early functional outcome of patients with an acute ankle sprain treated either with a semirigid, variable, phase-adapted modular ankle orthosis or an invariable orthotic reference device. Forty-seven patients with acute ankle sprain grade II or more were included. In addition, 77 healthy controls as a reference were investigated. The injured subjects were treated with one of the two devices by random for 6 weeks. Ankle scores (FAOS, AOFAS) were taken at baseline after injury, 1 and 3 months after injury. Functional performance tests (balance platform, zig zag run, shuttle run, vertical drop jump) were performed at 1 and 3 months after injury. No significant score differences could be found between the two intervention groups except for achieving a preinjury activity level after 3 months only in the modular orthosis group. Postural functional performances (balance test) also showed no significant differences whereas the results of the agility tests revealed small but significant better results in the modular orthosis group in comparison to the invariable orthosis group. Cohen's effect sizes were high. Differences between the two intervention groups were marginal and very small but significant and--regarding Cohen's effect sizes--effective. Especially relating to functional performance, this might be a careful indication that a more effective strategy for promoting a protected, rapid recovery to physical activity after ankle sprains might be achieved by applying a phase-adapted ankle orthosis. Especially in athletic patients, phase-adapted orthosis should be further investigated and considered to ensure fully protected ligament healing as well as to regain early functional recovery.

Comparison of group-based outpatient physiotherapy with usual care after total knee replacement: a feasibility study for a randomized controlled trial.

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Artz, Neil; Dixon, Samantha; Wylde, Vikki; Marques, Elsa; Beswick, Andrew D; Lenguerrand, Erik; Blom, Ashley W; Gooberman-Hill, Rachael

2017-04-01

To evaluate the feasibility of conducting a randomized controlled trial comparing group-based outpatient physiotherapy with usual care in patients following total knee replacement. A feasibility study for a randomized controlled trial. One secondary-care hospital orthopaedic centre, Bristol, UK. A total of 46 participants undergoing primary total knee replacement. The intervention group were offered six group-based exercise sessions after surgery. The usual care group received standard postoperative care. Participants were not blinded to group allocation. Feasibility was assessed by recruitment, reasons for non-participation, attendance, and completion rates of study questionnaires that included the Lower Extremity Functional Scale and Knee Injury and Osteoarthritis Outcome Score. Recruitment rate was 37%. Five patients withdrew or were no longer eligible to participate. Intervention attendance was high (73%) and 84% of group participants reported they were 'very satisfied' with the exercises. Return of study questionnaires at six months was lower in the usual care (75%) than in the intervention group (100%). Mean (standard deviation) Lower Extremity Functional Scale scores at six months were 45.0 (20.8) in the usual care and 57.8 (15.2) in the intervention groups. Recruitment and retention of participants in this feasibility study was good. Group-based physiotherapy was acceptable to participants. Questionnaire return rates were lower in the usual care group, but might be enhanced by telephone follow-up. The Lower Extremity Functional Scale had high responsiveness and completion rates. Using this outcome measure, 256 participants would be required in a full-scale randomized controlled trial.

Effect of Vitamin E on Oxaliplatin-induced Peripheral Neuropathy Prevention: A Randomized Controlled Trial.

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Salehi, Zeinab; Roayaei, Mahnaz

2015-01-01

Peripheral neuropathy is one of the most important limitations of oxaliplatin base regimen, which is the standard for the treatment of colorectal cancer. Evidence has shown that Vitamin E may be protective in chemotherapy-induced peripheral neuropathy. The aim of this study is to evaluate the effect of Vitamin E administration on prevention of oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer. This was a prospective randomized, controlled clinical trial. Patients with colorectal cancer and scheduled to receive oxaliplatin-based regimens were enrolled in this study. Enrolled patients were randomized into two groups. The first group received Vitamin E at a dose of 400 mg daily and the second group observed, until after the sixth course of the oxaliplatin regimen. For oxaliplatin-induced peripheral neuropathy assessment, we used the symptom experience diary questionnaire that completed at baseline and after the sixth course of chemotherapy. Only patients with a score of zero at baseline were eligible for this study. Thirty-two patients were randomized to the Vitamin E group and 33 to the control group. There was no difference in the mean peripheral neuropathy score changes (after - before) between two groups, after sixth course of the oxaliplatin base regimen (mean difference [after - before] of Vitamin E group = 6.37 ± 2.85, control group = 6.57 ± 2.94; P = 0.78). Peripheral neuropathy scores were significantly increased after intervention compared with a base line in each group (P peripheral neuropathy.

[Comparison of two antimicrobial prophylaxis regimens in biliary tract surgery: a randomized controlled clinical trial].

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Orozco, H; Sifuentes Osornio, J; Prado, E; Takahashi, T; López Graniel, C M; Anaya, E; Canto, J

1993-01-01

The aim of this study was to analyze the efficacy in prophylaxis during biliary tract and gallbladder surgery with amoxicillin/clavulanate and to compare it with the combination of cephalothin and clindamycin. A randomized nonblinded clinical trial with a blind independent observer. Tertiary-care center. Forty-two patients were included. All had undergone biliary tract and/or gallbladder surgery. They were divided in two groups: 22 in group A (cephalothin and clindamycin), and 20 in group B (amoxicillin/clavulanate). Patients from group A were intravenously treated with three doses of cephalothin (2 g at anesthetic induction and two additional doses of 1 g at six-hour intervals), and three of clindamycin (600 mg every six hours). Patients from group B received three doses of amoxicillin/clavulanate (1000/200 mg IV, one during the induction of the anesthesia followed by two more at six-hour intervals). In group A six wound infections were recorded, one of them with secondary bacteremia. In group B we did not record any infection (Fisher p clindamycin.

Reducing TV watching during adult obesity treatment: two pilot randomized controlled trials.

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Raynor, Hollie A; Steeves, Elizabeth Anderson; Bassett, David R; Thompson, Dixie L; Gorin, Amy A; Bond, Dale S

2013-12-01

The more time adults spend being sedentary, the greater the risk of obesity. The effect of reducing television (TV) watching, a prominent sedentary behavior, on weight loss has not been tested in an adult standard behavioral obesity intervention, and the mechanisms by which reducing TV watching influences energy balance behaviors are not well understood. Two, 8-week, pilot, randomized controlled trials were conducted examining the effect of a reduced TV watching prescription on energy balance behaviors and weight loss within an adult standard behavioral obesity intervention. In the first study, participants (n=24) were randomized into one of two conditions: (a) reduce energy intake and increase moderate to vigorous physical activity (MVPA) (INCREASE PA); or (b) reduce energy intake and decrease TV watching (DECREASE TV). As findings from the first pilot study did not show an increase in MVPA in the DECREASE TV group, the second study was designed to examine the effect of adding a reduced TV prescription to a standard intervention to optimize outcomes. In Pilot Study 2, participants (n=28) were randomized to INCREASE PA or to INCREASE PA+DECREASE TV. Outcomes included objectively measured TV watching and MVPA, self-reported light physical activity (LPA-Pilot Study 2 only), self-reported dietary intake while watching TV, and weight. Conditions with TV watching prescriptions significantly reduced TV watching. Both studies showed medium to large effect sizes for conditions with TV watching prescriptions to show greater reductions in dietary intake while watching TV. Pilot Study 1 found a trend for an increase in MVPA in INCREASE PA and Pilot Study 2 found significant increases in MVPA in both conditions. Pilot Study 2 found a significant increase in LPA in the INCREASE PA+DECREASE TV. Results indicate adding a TV watching prescription to a standard obesity intervention did not enhance increases in MVPA, but may assist with reducing dietary intake while TV watching and

Effectiveness of preemptive lysine clonixinate in tooth extraction: A randomized controlled trial.

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Pedro Aravena

2013-12-01

Full Text Available Aim: To evaluate the effectiveness of prophylaxis with single-dose analgesic clonixinate lysine (CL 125mg in patients undergoing tooth extraction. Methods: A double-blind randomized placebo-controlled trial. Were included in the study patients ASA I and II with dental extraction indication in the city of Valdivia, Chile in October 2012. Were randomly assigned in two groups: the treatment group received a doses of 125mg of CL fifteen minutes before the surgery, and a control group who received placebo. Both groups used a CL as a rescue analgesic. Using a survey, patients reported the degree of pain via a visual analog scale (VAS during the first day, at 24 and 48 hours after surgery. In addition, registered the number of CL capsules consumed as a ransom for 3 days after the surgery. We compared the analgesic effect observed in (VAS and the number of additional analgesic consumption between the two groups using t-test (p<0.05. Results: Fifty-four patients were operated and there was no statistically significant difference between the pain scores between the two groups. Premedication patients reported the use of equal number of rescue capsules comparing with the control group. Conclusion: CL analgesic prophylaxis proved no more effective in reducing pain after tooth extraction when comparing to the use of placebo in a postoperative doses.

Comparison of the effectiveness of two styles of case-based learning implemented in lectures for developing nursing students' critical thinking ability: A randomized controlled trial.

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Hong, Shaohua; Yu, Ping

2017-03-01

To explore and compare the effectiveness of two styles of case-based learning methods, unfolding nursing case and usual nursing case, implemented in lectures for developing nursing students' critical thinking ability. 122 undergraduate nursing students in four classes were taught the subject of medical nursing for one year. Two classes were randomly assigned as the experimental group and the other two the control group. The experimental group received the lectures presenting unfolding nursing cases and the control group was taught the usual cases. Nineteen case-based lectures were provided in 8 months in two semesters to each group. The two groups started with a similar level of critical thinking ability as tested by the instrument of Critical Thinking Disposition Inventory-Chinese version (CTDI-CV). After receiving 19 case-based learning lectures for 8 months, both groups of students significantly improved their critical thinking ability. The improvement in the experimental group was significantly higher than that in the control group (with the average total score of 303.77±15.24 vs. 288.34±13.94, plearning in lectures. Unfolding nursing cases appear to be significantly more effective than the usual nursing cases in developing undergraduate nursing students' critical thinking ability in the subject of medical nursing. Further research can implement the unfolding nursing cases in other nursing subjects. Copyright © 2016 Elsevier Ltd. All rights reserved.

Random a-adic groups and random net fractals

Energy Technology Data Exchange (ETDEWEB)

Li Yin [Department of Mathematics, Nanjing University, Nanjing 210093 (China)], E-mail: Lyjerry7788@hotmail.com; Su Weiyi [Department of Mathematics, Nanjing University, Nanjing 210093 (China)], E-mail: suqiu@nju.edu.cn

2008-08-15

Based on random a-adic groups, this paper investigates the relationship between the existence conditions of a positive flow in a random network and the estimation of the Hausdorff dimension of a proper random net fractal. Subsequently we describe some particular random fractals for which our results can be applied. Finally the Mauldin and Williams theorem is shown to be very important example for a random Cantor set with application in physics as shown in E-infinity theory.

Efficacy of extended-release tramadol for treatment of prescription opioid withdrawal: A two-phase randomized controlled trial*

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Lofwall, Michelle R.; Babalonis, Shanna; Nuzzo, Paul A.; Siegel, Anthony; Campbell, Charles; Walsh, Sharon L.

2013-01-01

Background Tramadol is an atypical analgesic with monoamine and modest mu opioid agonist activity. The purpose of this study was to evaluate: 1) the efficacy of extended-release (ER) tramadol in treating prescription opioid withdrawal and 2) whether cessation of ER tramadol produces opioid withdrawal. Methods Prescription opioid users with current opioid dependence and observed withdrawal participated in this inpatient, two-phase double blind, randomized placebo-controlled trial. In Phase 1 (days 1-7), participants were randomly assigned to matched oral placebo or ER tramadol (200 or 600 mg daily). In Phase 2 (days 8-13), all participants underwent double blind crossover to placebo. Breakthrough withdrawal medications were available for all subjects. Enrollment continued until 12 completers/group was achieved. Results Use of breakthrough withdrawal medication differed significantly (popioid withdrawal. Mild opioid withdrawal occurred after cessation of treatment with 600 mg tramadol. These data support the continued investigation of tramadol as a treatment for opioid withdrawal. PMID:23755929

Efficacy of extended-release tramadol for treatment of prescription opioid withdrawal: a two-phase randomized controlled trial.

Science.gov (United States)

Lofwall, Michelle R; Babalonis, Shanna; Nuzzo, Paul A; Siegel, Anthony; Campbell, Charles; Walsh, Sharon L

2013-11-01

Tramadol is an atypical analgesic with monoamine and modest mu opioid agonist activity. The purpose of this study was to evaluate: (1) the efficacy of extended-release (ER) tramadol in treating prescription opioid withdrawal and (2) whether cessation of ER tramadol produces opioid withdrawal. Prescription opioid users with current opioid dependence and observed withdrawal participated in this inpatient, two-phase double blind, randomized placebo-controlled trial. In Phase 1 (days 1-7), participants were randomly assigned to matched oral placebo or ER tramadol (200 or 600 mg daily). In Phase 2 (days 8-13), all participants underwent double blind crossover to placebo. Breakthrough withdrawal medications were available for all subjects. Enrollment continued until 12 completers/group was achieved. Use of breakthrough withdrawal medication differed significantly (popioid withdrawal. Mild opioid withdrawal occurred after cessation of treatment with 600 mg tramadol. These data support the continued investigation of tramadol as a treatment for opioid withdrawal. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

A Randomized Controlled Trial of a Mindfulness and Acceptance Group Therapy for Residential Substance Use Patients.

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Shorey, Ryan C; Elmquist, Joanna; Gawrysiak, Michael J; Strauss, Catherine; Haynes, Ellen; Anderson, Scott; Stuart, Gregory L

2017-09-19

Substance use disorders are understood as a chronically relapsing condition that is difficult to treat. However, in recent years there have been promising developments in the treatment of substance use disorders, specifically with interventions based on mindfulness and acceptance and commitment therapy. Little research has examined whether these types of interventions may positively impact residential substance use treatment outcomes. Thus, in the current study we developed and examined, in a randomized controlled trial, a 4-week, eight-session, adjunctive mindfulness and acceptance group therapy for patients in residential substance use treatment. Our primary outcomes were substance use cravings, psychological flexibility, and dispositional mindfulness at treatment discharge. Patients (N = 117) from a private residential substance use facility were randomized to receive the adjunctive mindfulness and acceptance group or treatment-as-usual. Patients were assessed at treatment intake and at discharge from a 28-30-day residential program. Although treatment groups did not statistically differ at discharge on any primary outcome, small effect sizes favored the mindfulness and acceptance group on cravings and psychological flexibility. Conclusions/Importance: Continued research is needed to determine whether the addition of mindfulness and acceptance-based interventions improve outcomes long term following residential substance use treatment.

Heparin for prolonging peripheral intravenous catheter use in neonates: a randomized controlled trial.

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Upadhyay, A; Verma, K K; Lal, P; Chawla, D; Sreenivas, V

2015-04-01

To determine the efficacy of heparinized saline administered as intermittent flush on functional duration of the peripheral intravenous catheter (PIVC) in neonates. Randomized, double-blind and placebo-controlled trial. Neonatal intensive care unit of a teaching hospital. Term and preterm neonates born at >32 weeks of gestation who required PIVC only for intermittent administration of antibiotics. Eligible neonates were randomized to receive 1 ml of either heparinized saline (10 U ml(-1)) (n=60) or normal saline (n=60) every 12 h before and after intravenous antibiotics. Functional duration of first peripheral intravenous catheter. A total of 120 neonates were randomized to two groups of 60 neonates each. The mean (s.d.) of age of babies in case and control group was 5.7 (2.5) days and 4.6 (3.1) days, respectively. The average weight of babies in both the groups was 2.1 kg. Mean functional duration of first catheter was more in heparinized saline group, mean (s.d.) of 71.68 h  (27.3) as compared with 57.7 h (23.6) in normal saline group (P<0.005). The mean (95% confidence interval) difference in functional duration in the two groups was 13.9 h (4.7-23.15). Mean duration of patency for any catheter was also significantly more in heparinized saline group than control group. Heparinized saline flush increases the functional duration of peripheral intravenous catheter.

Specific collaborative group intervention for patients with medically unexplained symptoms in general practice: a cluster randomized controlled trial.

Science.gov (United States)

Schaefert, R; Kaufmann, C; Wild, B; Schellberg, D; Boelter, R; Faber, R; Szecsenyi, J; Sauer, N; Guthrie, E; Herzog, W

2013-01-01

Patients with medically unexplained symptoms (MUS) are frequent in primary care and substantially impaired in their quality of life (QoL). Specific training of general practitioners (GPs) alone did not demonstrate sustained improvement at later follow-up in current reviews. We evaluated a collaborative group intervention. We conducted a cluster randomized controlled trial. Thirty-five GPs recruited 304 MUS patients (intervention group: 170; control group: 134). All GPs were trained in diagnosis and management of MUS (control condition). Eighteen randomly selected intervention GPs participated in training for a specific collaborative group intervention. They conducted 10 weekly group sessions and 2 booster meetings in their practices, together with a psychosomatic specialist. Six and 12 months after baseline, QoL was assessed with the Short-Form 36. The primary outcome was the physical composite score (PCS), and the secondary outcome was the mental composite score (MCS). At 12 months, intention-to-treat analyses showed a significant between-group effect for the MCS (p = 0.023) but not for the PCS (p = 0.674). This effect was preceded by a significant reduction of somatic symptom severity (15-item somatic symptom severity scale of the Patient Health Questionnaire, PHQ-15) at 6 months (p = 0.008) that lacked significance at 12 months (p = 0.078). As additional between-group effects at 12 months, per-protocol analyses showed less health anxiety (Whiteley-7; p = 0.038) and less psychosocial distress (PHQ; p = 0.024); GP visits were significantly (p = 0.042) reduced in the intervention group. Compared to pure GP training, collaborative group intervention achieved a progressive, clinically meaningful improvement in mental but not physical QoL. It could bridge gaps between general practice and mental health care. Copyright © 2012 S. Karger AG, Basel.

A two-arm cluster randomized control trial to determine the effectiveness of a pressure ulcer prevention bundle for critically ill patients.

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Tayyib, Nahla; Coyer, Fiona; Lewis, Peter A

2015-05-01

This study tested the effectiveness of a pressure ulcer (PU) prevention bundle in reducing the incidence of PUs in critically ill patients in two Saudi intensive care units (ICUs). A two-arm cluster randomized experimental control trial. Participants in the intervention group received the PU prevention bundle, while the control group received standard skin care as per the local ICU policies. Data collected included demographic variables (age, diagnosis, comorbidities, admission trajectory, length of stay) and clinical variables (Braden Scale score, severity of organ function score, mechanical ventilation, PU presence, and staging). All patients were followed every two days from admission through to discharge, death, or up to a maximum of 28 days. Data were analyzed with descriptive correlation statistics, Kaplan-Meier survival analysis, and Poisson regression. The total number of participants recruited was 140: 70 control participants (with a total of 728 days of observation) and 70 intervention participants (784 days of observation). PU cumulative incidence was significantly lower in the intervention group (7.14%) compared to the control group (32.86%). Poisson regression revealed the likelihood of PU development was 70% lower in the intervention group. The intervention group had significantly less Stage I (p = .002) and Stage II PU development (p = .026). Significant improvements were observed in PU-related outcomes with the implementation of the PU prevention bundle in the ICU; PU incidence, severity, and total number of PUs per patient were reduced. Utilizing a bundle approach and standardized nursing language through skin assessment and translation of the knowledge to practice has the potential to impact positively on the quality of care and patient outcome. © 2015 Sigma Theta Tau International.

Cost-Effectiveness of Group and Internet Cognitive Behavioral Therapy for Insomnia in Adolescents: Results from a Randomized Controlled Trial.

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De Bruin, Eduard J; van Steensel, Francisca J A; Meijer, Anne Marie

2016-08-01

To investigate cost-effectiveness of adolescent cognitive behavioral therapy for insomnia (CBTI) in group- and Internet-delivered formats, from a societal perspective with a time horizon of 1 y. Costs and effects data up to 1-y follow-up were obtained from a randomized controlled trial (RCT) comparing Internet CBTI to face-to-face group CBTI. The study was conducted at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam, and the academic youth mental health care center UvAMinds in Amsterdam. Sixty-two participants meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for insomnia were randomized to face-to-face group CBTI (GT; n = 31, age = 15.6 y ± 1.8, 71.0% girls) or individual Internet CBTI (IT; n = 31, age = 15.4 y ± 1.5, 83.9% girls). The intervention consisted of six weekly sessions and a 2-mo follow up booster-session of CBTI, consisting of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT sessions were held in groups of six to eight adolescents guided by two trained sleep therapists. IT consisted of individual Internet therapy with preprogrammed content similar to GT, and guided by trained sleep therapists. Outcome measures were subjective sleep efficiency (SE) ≥ 85%, and quality-adjusted life-years (QALY). Analyses were conducted from a societal perspective. Incremental cost-effectiveness ratios (ICERs) were calculated using bootstrap sampling, and presented in cost-effectiveness planes. Primary analysis showed costs over 1 y were higher for GT but effects were similar for IT and GT. Bootstrapped ICERs demonstrated there is a high probability of IT being cost-effective compared to GT. Secondary analyses confirmed robustness of results. Internet CBTI is a cost-effective treatment compared to group CBTI for adolescents, although effects were largely similar for both formats

Reanalysis of morphine consumption from two randomized controlled trials of gabapentin using longitudinal statistical methods

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Zhang S

2015-02-01

Full Text Available Shiyuan Zhang,1 James Paul,2 Manyat Nantha-Aree,2 Norman Buckley,2 Uswa Shahzad,2 Ji Cheng,2 Justin DeBeer,5 Mitchell Winemaker,5 David Wismer,5 Dinshaw Punthakee,5 Victoria Avram,5 Lehana Thabane1–4 1Department of Clinical Epidemiology and Biostatistics, McMaster University, 2Department of Anesthesia, McMaster University, 3Biostatistics Unit/Centre for Evaluation of Medicines, St Joseph’s Healthcare-Hamilton, 4Population Health Research Institute, Hamilton Health Science/McMaster University, 5Department of Surgery, Division of Orthopaedics, McMaster University, Hamilton, ON, Canada Background: Postoperative pain management in total joint replacement surgery remains ineffective in up to 50% of patients and has an overwhelming impact in terms of patient well-being and health care burden. We present here an empirical analysis of two randomized controlled trials assessing whether addition of gabapentin to a multimodal perioperative analgesia regimen can reduce morphine consumption or improve analgesia for patients following total joint arthroplasty (the MOBILE trials. Methods: Morphine consumption, measured for four time periods in patients undergoing total hip or total knee arthroplasty, was analyzed using a linear mixed-effects model to provide a longitudinal estimate of the treatment effect. Repeated-measures analysis of variance and generalized estimating equations were used in a sensitivity analysis to compare the robustness of the methods. Results: There was no statistically significant difference in morphine consumption between the treatment group and a control group (mean effect size estimate 1.0, 95% confidence interval −4.7, 6.7, P=0.73. The results remained robust across different longitudinal methods. Conclusion: The results of the current reanalysis of morphine consumption align with those of the MOBILE trials. Gabapentin did not significantly reduce morphine consumption in patients undergoing major replacement surgeries. The

Reinforcement Behavior Therapy by Kindergarten Teachers on Preschool Children’s Aggression: A Randomized Controlled Trial

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Shahrzad Yektatalab

2016-01-01

Full Text Available Background: Aggression is a kind of behavior that causes damage or harm to others. The prevalence of aggression is 8–20% in 3–6 years old children. The present study aimed to assess the effect of training kindergarten teachers regarding reinforcement behavior therapy on preschoolers’ aggression. Methods: In this cluster randomized control trial, 14 out of 35 kindergarten and preschool centers of Mohr city, Iran, were chosen using random cluster sampling and then randomly assigned to an intervention and a control group. All 370 kindergarten and preschool children in 14 kindergarten were assessed by preschoolers’ aggression questionnaire and 60 children who obtained a minimum aggression score of 117.48 for girls and 125.77 for boys were randomly selected. The teachers in the intervention group participated in 4 educational sessions on behavior therapy and then practiced this technique under the supervision of the researcher for two months. Preschoolers’ aggression questionnaire was computed in both intervention and control groups before and after a two-month period. Results: The results demonstrated a significant statistical difference in the total aggression score (P=0.01, verbal (P=0.02 and physical (P=0.01 aggression subscales scores in the intervention group in comparison to the control group after the intervention. But the scores of relational aggression (P=0.09 and impulsive anger (P=0.08 subscales were not statistically different in the intervention group compared to the controls. Conclusion: This study highlighted the importance of teaching reinforcement behavior therapy by kindergarten teachers in decreasing verbal and physical aggression in preschoolers.

Evaluation of the Efficacy and Color Stability of Two Different At-Home Bleaching Systems on Teeth of Different Shades: A Randomized Controlled Clinical Trial.

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Aka, Betül; Celik, Esra Uzer

2017-09-01

This randomized controlled clinical trial compared the bleaching efficacy of two different at-home bleaching systems on teeth of different shades and their color stability after a 6-month follow-up. Ninety-two patients (777 teeth) were randomly divided into three groups: (a) negative control, (b) patients treated with a custom-made tray containing 10% carbamide peroxide (10% CP/PF) (Opalescence PF), and (c) patients treated with a pre-loaded tray containing 6% hydrogen peroxide (6% HP/Go) (Opalescence Go). Teeth in all groups were divided into three sub-groups according to the VITA Classic Shade Guide: light (A1-C1), medium dark (C2-B3), and dark (A3.5-C4). Bleaching systems were performed in accordance with manufacturers' instructions for 14 days. The color values were measured at the baseline, 10 days and 14 days of bleaching, 2 weeks, and 6 months after bleaching. Three-way ANOVA and Mann-Whitney U tests were used for statistical analysis (α = 0.05). Irrespective of original shade, both bleaching groups showed significantly higher ΔE* values than the control groups, and the ΔE* values were significantly higher in the 10% CP/PF groups than those in the 6% HP/Go groups (p bleaching systems, the dark teeth showed higher ΔE* values than the light teeth (p bleaching agents produced a bleaching effect, but 10% CP/PF was more effective. A pre-loaded tray system may be used for dental bleaching, but it is still less effective than conventional a 10% carbamide peroxide system, irrespective of the initial shade. (J Esthet Restor Dent 29:325-338, 2017). © 2017 Wiley Periodicals, Inc.

Effects of two exercise protocols on postural balance of elderly women: a randomized controlled trial.

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Mesquita, Laiana Sepúlveda de Andrade; de Carvalho, Fabiana Texeira; Freire, Lara Sepúlveda de Andrade; Neto, Osmar Pinto; Zângaro, Renato Amaro

2015-06-02

The aging process reduces both sensory capabilities and the capabilities of the motor systems responsible for postural control, resulting in a high number of falls among the elderly. Some therapeutic interventions can directly interrupt this process, including physical exercise. This study compares and examines the effects of two exercise protocols on the balance of elderly women. Elderly women who participated in a local church project (n = 63) were randomly divided into three groups: the proprioceptive neuromuscular facilitation group (PNFG), Pilates group (PG), and control group (CG). Of the 63 women, 58 completed the program. A training program involving 50-min sessions was performed in the PNFG and PG three times a week for 4 weeks. The elderly women in the CG received no intervention and continued with their daily activities. Stabilometric parameters, the Berg Balance Scale score, functional reach test, and timed up and go test (TUG test) were assessed before and 1 month after participation. In the comparison among groups, the women in the PNFG showed a significant reduction in most of the stabilometric parameters evaluated and better Berg Balance Scale score, functional reach test result, and TUG test result than did women in the CG (p functional reach test and TUG test than did women in the CG (p < 0.05). Women in the PNFG showed significantly better static and dynamic balance than did women in the CG. Women in the PG also showed better dynamic balance than did women in the CG. However, no significant differences were observed in any of the balance variables assessed between the PNFG and PG. clinicaltrials.gov, number NCT02278731.

Improving insomnia in primary care patients: A randomized controlled trial of nurse-led group treatment.

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Sandlund, Christina; Hetta, Jerker; Nilsson, Gunnar H; Ekstedt, Mirjam; Westman, Jeanette

2017-07-01

Insomnia is a common health problem, and most people who seek help for insomnia consult primary care. In primary care, insomnia treatment typically consists of hypnotic drugs, although cognitive behavioral therapy for insomnia is the recommended treatment. However, such treatment is currently available to few primary care patients. To evaluate the effects of a group treatment program for insomnia led by nurses in primary care. were the Insomnia Severity Index, a 2-week sleep diary, and a questionnaire on frequency of hypnotic drug use. A randomized controlled trial with pre- and post-treatment assessment and a 1-year post-treatment follow-up of the intervention group. Routine primary health care; 7 primary care centers in Stockholm, Sweden. Patients consulting primary care for insomnia were assessed for eligibility. To be included, patients had to have insomnia disorder and be 18 years or older. Patients were excluded if they if they worked night shifts or had severe untreated somatic and/or mental illness, bipolar disorder, or untreated sleep disorder other than insomnia. One-hundred and sixty-five patients 20 to 90 years were included. Most were women, and many had co-existing somatic and/or mental health problems. The post-treatment dropout rate was 20%. The intervention was a nurse-led group treatment for insomnia based on the techniques of cognitive behavioral therapy for insomnia. The nurses had 2days of training in how to deliver the program. Ninety patients were randomized to the intervention and 75 to the control group (treatment as usual). Data from 82 in the intervention and 71 in the control group were analyzed in accordance with intention-to-treat principles. Fifty-four of the 72 in the intervention group who participated in the group treatment program were followed up after 1year. Mean Insomnia Severity Index score decreased significantly from 18.4 to 10.7 after group treatment but remained unchanged after treatment as usual (17.0 to 16.6). The effect

Social support and education groups for single mothers: a randomized controlled trial of a community-based program.

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Lipman, Ellen L; Boyle, Michael H

2005-12-06

Members of families headed by single mothers are at increased risk of psychosocial disadvantage and mental health problems. We assessed the effect of a community-based program of social support and education groups for single mothers of young children on maternal well-being and parenting. We recruited 116 single mothers of children 3 to 9 years old through community advertisements. Eligible mothers were randomly assigned either to participate in a 10-week program of group sessions (1.5 hours per week) offering social support and education, with a parallel children's activity group, or to receive a standard list of community resources and the option to participate in group sessions at the end of the follow-up period. Interviewers blinded to the randomization collected assessment data from all mothers at baseline and at 3 follow-up visits (immediately after the intervention and at 3 and 6 months after the intervention). Outcome measures were self-reported mood, self-esteem, social support and parenting. Between February 2000 and April 2003, the program was offered to 9 groups of single mothers. Most of the mothers in the trial reported high levels of financial and mental health problems. In the short term (after the intervention), mothers in the intervention group had improved scores for mood (p effect = 0.55) and self-esteem (p effect = 0.29) compared with mothers in the control group; scores for the other 2 measures did not differ between the groups. Growth curve analysis of program effects over the follow-up period showed improvement in all 4 outcomes, with no significant difference between the intervention and control groups. This community-based program of group sessions offering social support and education to low-income single mothers had positive short-term effects on mood and self-esteem but not on social support and parenting. Longer follow-up showed attenuation of these effects.

A randomized controlled trial of support group intervention after breast cancer treatment: results on sick leave, health care utilization and health economy.

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Björneklett, Helena Granstam; Rosenblad, Andreas; Lindemalm, Christina; Ojutkangas, Marja-Leena; Letocha, Henry; Strang, Peter; Bergkvist, Leif

2013-01-01

More than 50% of breast cancer patients are diagnosed before the age of 65. Returning to work after treatment is, therefore, of interest for both the individual and society. The aim was to study the effect of support group intervention on sick leave and health care utilization in economic terms. Of 382 patients with newly diagnosed breast cancer, 191 + 191 patients were randomized to an intervention group or to a routine control group, respectively. The intervention group received support intervention on a residential basis for one week, followed by four days of follow-up two months later. The support intervention included informative-educational sections, relaxation training, mental visualization and non-verbal communication. Patients answered a questionnaire at baseline, two, six and 12 months about sick leave and health care utilization. There was a trend towards longer sick leave and more health care utilization in the intervention group. The difference in total costs was statistically significantly higher in the intervention group after 12 months (p = 0.0036). Costs to society were not reduced with intervention in its present form.

Yoga in Correctional Settings: A Randomized Controlled Study

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Nóra Kerekes

2017-10-01

Full Text Available BackgroundThe effect of yoga in the reduction of depressive symptoms, anxiety, stress, anger as well as in the increased ability of behavioral control has been shown. These effects of yoga are highly relevant for prison inmates who often have poor mental health and low impulse control. While it has been shown that yoga and meditation can be effective in improving subjective well-being, mental health, and executive functioning within prison populations, only a limited number of studies have proved this, using randomized controlled settings.MethodsA total of 152 participants from nine Swedish correctional facilities were randomly assigned to a 10-week yoga group (one class a week; N = 77 or a control group (N = 75. Before and after the intervention period, participants answered questionnaires measuring stress, aggression, affective states, sleep quality, and psychological well-being and completed a computerized test measuring attention and impulsivity.ResultsAfter the intervention period, significant improvements were found on 13 of the 16 variables within the yoga group (e.g., less perceived stress, better sleep quality, an increased psychological and emotional well-being, less aggressive, and antisocial behavior and on two within the control group. Compared to the control group, yoga class participants reported significantly improved emotional well-being and less antisocial behavior after 10 weeks of yoga. They also showed improved performance on the computerized test that measures attention and impulse control.ConclusionIt can be concluded that the yoga practiced in Swedish correctional facilities has positive effects on inmates’ well-being and on considerable risk factors associated with recidivism, such as impulsivity and antisocial behavior. Accordingly, the results show that yoga practice can play an important part in the rehabilitation of prison inmates.

Transverse vs torsional ultrasound: prospective randomized contralaterally controlled study comparing two phacoemulsification-system handpieces.

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Assil, Kerry K; Harris, Lindsay; Cecka, Jeannie

2015-01-01

To compare surgical efficiency and multiple early clinical outcome variables in eyes undergoing phacoemulsification using either transversal or torsional ultrasound systems. Assil Eye Institute, Beverly Hills, CA, USA. Prospective, randomized, clinician-masked, contralaterally controlled single-center evaluation. Patients seeking cataract removal in both eyes with implantation of multifocal intraocular lenses were randomly assigned to one of two treatment rooms for phacoemulsification with either a transverse ultrasound system or torsional handpiece system. The contralateral eye was treated at a later date with the alternate device. A total of 54 eyes of 27 patients having similar degrees of cataract, astigmatism, and visual potential were included. All operative data were collected for analysis, and patients were followed for 3 months after surgery. Similar visual acuity was reported at all postoperative visits between the two groups. Mean phacoemulsification time and total power required were both significantly lower with the transverse system than with the torsional technique (Ptransverse system vs torsional (Ptransverse vs torsional. Macular swelling was less at 1 week, 1 month, and 3 months with transverse vs torsional, although the difference did not achieve significance (P=0.1) at any single time point. Clinically detectable corneal edema was reported less frequently at all postoperative time points with the transverse system. The transverse ultrasound system was found to be possibly associated with less balanced salt-solution use, less phacoemulsification time, and less power required than the torsional phaco system. Postoperative data suggested that improved phaco efficiency may translate to a better overall safety profile for the patient.

Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

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Pradhan, M.; Brinkman, S.A.; Beatty, A.; Maika, A.; Satriawan, E.; de Ree, J.; Hasan, A.

2013-01-01

Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program

Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

NARCIS (Netherlands)

Pradhan, M.P.; Brinkman, S.A.; Beatty, A.; Maika, A.; Satriawan, E.; de Ree, J.; Hasan, A.

2013-01-01

Background: This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program

Evaluation of two vaccine education interventions to improve pertussis vaccination among pregnant African American women: A randomized controlled trial.

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Kriss, Jennifer L; Frew, Paula M; Cortes, Marielysse; Malik, Fauzia A; Chamberlain, Allison T; Seib, Katherine; Flowers, Lisa; Ault, Kevin A; Howards, Penelope P; Orenstein, Walter A; Omer, Saad B

2017-03-13

Vaccination coverage with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in pregnancy or immediately postpartum has been low. Limited data exist on rigorously evaluated interventions to increase maternal vaccination, including Tdap. Tailored messaging based on the Elaboration Likelihood Model (ELM) framework has been successful in improving uptake of some public health interventions. We evaluated the effect of two ELM-based vaccine educational interventions on Tdap vaccination among pregnant African American women, a group of women who tend to have lower vaccine uptake compared with other groups. We conducted a prospective randomized controlled trial to pilot test two interventions - an affective messaging video and a cognitive messaging iBook - among pregnant African American women recruited during routine prenatal care visits. We measured Tdap vaccination during the perinatal period (during pregnancy and immediately postpartum), reasons for non-vaccination, and intention to receive Tdap in the next pregnancy. Among the enrolled women (n=106), 90% completed follow-up. Tdap vaccination in the perinatal period was 18% in the control group; 50% in the iBook group (Risk Ratio [vs. control group]: 2.83; 95% CI, 1.26-6.37), and 29% in the video group (RR: 1.65; 95% CI, 0.66-4.09). From baseline to follow-up, women's reported intention to receive Tdap during the next pregnancy improved in all three groups. Among unvaccinated women, the most common reason reported for non-vaccination was lack of a recommendation for Tdap by the woman's physician. Education interventions that provide targeted information for pregnant women in an interactive manner may be useful to improve Tdap vaccination during the perinatal period. However, larger studies including multiple racial and ethnic groups are needed to evaluate robustness of our findings. clinicaltrials.gov Identifier: NCT01740310. Copyright © 2017 Elsevier Ltd. All rights reserved.

Randomized controlled study of CBT in bronchial asthma

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Grover Naveen

2007-01-01

Full Text Available The aim of the present study was to find out efficacy of cognitive behavior therapy, as an adjunct to standard pharmacotherapy, in bronchial asthma. In a random-ized two-group design with pre-and post assessments, forty asthma patients were randomly allotted to two groups: self management group and cognitive behavior therapy group. Both groups were exposed to 6-8 weeks of intervention, asthma self management program and cognitive behavior therapy. Assessment measures used were-Semi structured interview schedule, Asthma Symptom Checklist, Asthma di-ary, Asthma Bother Profile, Hospital Anxiety & Depression Scale, AQLQ and Peak Expiratory Flow Rate. Within group comparison showed significant improvement in both groups at the post assessment. Between group comparisons showed that CBT group reported significantly greater change than that of SM group. Cognitive behavior therapy helps in improving the managment of asthma.

TEACCH-based group social skills training for children with high-functioning autism: a pilot randomized controlled trial.

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Ichikawa, Kayoko; Takahashi, Yoshimitsu; Ando, Masahiko; Anme, Tokie; Ishizaki, Tatsuro; Yamaguchi, Hinako; Nakayama, Takeo

2013-10-01

Although social skills training programs for people with high-functioning autism (HFA) are widely practiced, the standardization of curricula, the examination of clinical effectiveness, and the evaluation of the feasibility of future trials have yet to be done in Asian countries. To compensate for this problem, a Japanese pilot randomized controlled trial (RCT) of the Treatment and Education of Autistic and Related Communication Handicapped Children (TEACCH)-based group social skills training for children with HFA and their mothers was conducted. Eleven children with HFA, aged 5-6 years, and their mothers were randomly assigned to the TEACCH program (n=5) or a waiting-list control group (n=6). The program involved comprehensive group intervention and featured weekly 2-hour sessions, totaling 20 sessions over six months. The adaptive behaviors and social reciprocity of the children, parenting stress, and parent-child interactions were assessed using the Strengths and Difficulties Questionnaire (SDQ), Parenting Stress Index (PSI), Beck depression inventory-II (BDI-II), and Interaction Rating Scale (IRS). Through this pilot trial, the intervention and evaluation of the program has been shaped. There were no dropouts from the program and the mothers' satisfaction was high. The outcome measurements improved more in the program group than in the control group, with moderate effect sizes (SDQ, 0.71; PSI, 0.58; BDI-II, 0.40; and IRS, 0.69). This pilot trial also implied that this program is more beneficial for high IQ children and mothers with low stress than for those who are not. We have standardized the TEACCH program, confirmed the feasibility of a future trial, and successfully estimated the positive effect size. These findings will contribute to a larger trial in the future and to forthcoming systematic reviews with meta-analyses. UMIN000004560.

Clinical pharmacists on medical care of pediatric inpatients: a single-center randomized controlled trial.

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Chuan Zhang

Full Text Available OBJECTIVE: To explore the best interventions and working patterns of clinical pharmacists in pediatrics and to determine the effectiveness of clinical pharmacists in pediatrics. METHODS: We conducted a randomized controlled trial of 160 pediatric patients with nerve system disease, respiratory system disease or digestive system disease, who were randomly allocated into two groups, with 80 in each group. Interventions by clinical pharmacists in the experimental group included answering questions of physicians and nurses, giving advice on treating patients, checking prescriptions and patient counseling at discharge. In the control group, patients were treated without clinical pharmacist interventions. RESULTS: Of the 109 interventions provided by clinical pharmacists during 4 months, 47 were consultations for physicians and nurses, 31 were suggestions of treatment, with 30 accepted by physicians (96.77% and 31 were medical errors found in 641 prescriptions. Five adverse drug reactions were submitted to the adverse drug reaction monitoring network, with three in the experimental group and two in the control group. The average length of stay (LOS for patients with respiratory system diseases in the experimental group was 6.45 days, in comparison with 10.83 days in the control group, which was statistically different (p value<0.05; Average drug compliance rate in the experimental group was 81.41%, in comparison with 70.17% of the control group, which was statistically different (p value<0.05. Cost of drugs and hospitalization and rate of readmission in two weeks after discharge in the two groups were not statistically different. CONCLUSION: Participation by clinical pharmacists in the pharmacotherapy of pediatric patients can reduce LOS of patients with respiratory system disease and improve compliance rate through discharge education, showing no significant effects on prevention of ADR, reduction of cost of drugs and hospitalization and readmission

Random walks on reductive groups

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Benoist, Yves

2016-01-01

The classical theory of Random Walks describes the asymptotic behavior of sums of independent identically distributed random real variables. This book explains the generalization of this theory to products of independent identically distributed random matrices with real coefficients. Under the assumption that the action of the matrices is semisimple – or, equivalently, that the Zariski closure of the group generated by these matrices is reductive - and under suitable moment assumptions, it is shown that the norm of the products of such random matrices satisfies a number of classical probabilistic laws. This book includes necessary background on the theory of reductive algebraic groups, probability theory and operator theory, thereby providing a modern introduction to the topic.

Aloe vera gel and cesarean wound healing; a randomized controlled clinical trial.

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Molazem, Zahra; Mohseni, Fatemeh; Younesi, Masoumeh; Keshavarzi, Sareh

2014-08-31

Failure in complete healing of the wound is one of the probable complications of cesarean. The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound. This prospective randomized double-blind clinical trial was conducted on 90 women who had undergone cesarean operation in Amir-al-Momenin hospital (Gerash, Iran). The participants were randomly divided into two groups each containing 45 patients. In one group, the wound was dressed with aloe vera gel, while simple dressing was used in the control group. Wound healing was assessed 24 hours and 8 days after the cesarean operation using REEDA scale. The data were analyzed through Chi-square and t-test. The participants' mean age was 27.56±4.20 in the aloe vera group and 26.62±4.88 in the control group, but the difference was not statistically significant. However, a significant difference was found between the two groups concerning body mass index, heart rate, and systolic blood pressure (Paloe vera group and 35 ones in the control group had obtained a zero score 24 hours after the operation. These measures were respectively obtained as 42 and 41eight days after the operation. According to the findings of this study, the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel.

The benefits of giving a massage on the mental state of massage therapists: a randomized, controlled trial.

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Jensen, Anne M; Ramasamy, Adaikalavan; Hotek, Judith; Roel, Brian; Riffe, Drew

2012-12-01

The objective of this study was to determine whether giving a massage had an impact of the mental state of the massage therapist. The design of this study was a randomized, controlled, blinded study with two parallel groups. This study was conducted at an accredited school of therapeutic massage in Dallas, Texas. The study comprised healthy female and male final-term massage students between ages 18 and 65 years. The participants were randomized into two groups: (1) the experimental group who gave a 1-hour Swedish massage to a massage client (Massage group), or (2) the control group who sat in a room doing normal, daily activities (Control group). Both these activities were a normal part of the daily routine for these massage students. The primary outcomes were the change in the Depression Anxiety and Stress Scale (DASS) scores pre- and postparticipation. Twenty-two (22) participants were randomized in this trial. The baseline characteristics were comparable between the two groups. A statistically significant advantage for the massage group was found relative to the control group in subjective anxiety (DASS Anxiety Subscale, p=0.014). There were no significant differences between the groups with regard to total DASS score (p=0.540), subjective depressive symptoms (DASS Depression Subscale, p=0.472) and subjective stress-related symptoms (DASS Stress Subscale, p=0.919). There were no adverse events reported by any participant. This study shows that massage therapists themselves may benefit from giving a therapeutic massage by experiencing less subjective anxiety following the giving of a massage.

Comparing Acceptance and Commitment Group Therapy and 12-Steps Narcotics Anonymous in Addict’s Rehabilitation Process: A Randomized Controlled Trial

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Manoochehr Azkhosh

2016-12-01

Full Text Available Objective: Substance abuse is a socio-psychological disorder. The aim of this study was to compare the effectiveness of acceptance and commitment therapy with 12-steps Narcotics Anonymous on psychological well-being of opiate dependent individuals in addiction treatment centers in Shiraz, Iran.Method: This was a randomized controlled trial. Data were collected at entry into the study and at post-test and follow-up visits. The participants were selected from opiate addicted individuals who referred to addiction treatment centers in Shiraz. Sixty individuals were evaluated according to inclusion/ exclusion criteria and were divided into three equal groups randomly (20 participants per group. One group received acceptance and commitment group therapy (Twelve 90-minute sessions and the other group was provided with the 12-steps Narcotics Anonymous program and the control group received the usual methadone maintenance treatment. During the treatment process, seven participants dropped out. Data were collected using the psychological well-being questionnaire and AAQ questionnaire in the three groups at pre-test, post-test and follow-up visits. Data were analyzed using repeated measure analysis of variance.Results: Repeated measure analysis of variance revealed that the mean difference between the three groups was significant (P<0.05 and that acceptance and commitment therapy group showed improvement relative to the NA and control groups on psychological well-being and psychological flexibility.Conclusion: The results of this study revealed that acceptance and commitment therapy can be helpful in enhancing positive emotions and increasing psychological well-being of addicts who seek treatment.

Mindfulness Training Improves Attentional Task Performance in Incarcerated Youth: A Group Randomized Controlled Intervention Trial

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Noelle R Leonard

2013-11-01

Full Text Available We investigated the impact of cognitive behavioral therapy and mindfulness training (CBT/MT on attentional task performance in incarcerated adolescents. Attention is a cognitive system necessary for managing cognitive demands and regulating emotions. Yet persistent and intensive demands, such as those experienced during high-stress intervals like incarceration and the events leading to incarceration, may deplete attention resulting in cognitive failures, emotional disturbances, and impulsive behavior. We hypothesized that CBT/MT may mitigate these deleterious effects of high stress and protect against degradation in attention over the high-stress interval of incarceration. Using a group randomized controlled trial design, we randomly assigned dormitories of incarcerated youth, ages 16 to 18, to a CBT/MT intervention (youth n = 147 or an active control intervention (youth n = 117. Both arms received approximately 750 minutes of intervention in a small-group setting over a 3-5 week period. Youth in the CBT/MT arm also logged the amount of out-of-session time spent practicing MT exercises. The Attention Network Test was used to index attentional task performance at baseline and 4 months post-baseline. Overall, task performance degraded over time in all participants. The magnitude of performance degradation was significantly less in the CBT/MT vs. control arm. Further, within the CBT/MT arm, performance degraded over time in those with no outside-of-class practice time, but remained stable over time in those who practiced mindfulness exercises outside of the session meetings. Thus, these findings suggest that sufficient CBT/MT practice may protect against functional attentional impairments associated with high-stress intervals. Keywords: adolescent development, incarcerated adolescents, detained adolescents, stress, attention, mindfulness meditation.

A 1-year videoconferencing-based psychoeducational group intervention following bariatric surgery: results of a randomized controlled study.

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Wild, Beate; Hünnemeyer, Katharina; Sauer, Helene; Hain, Bernhard; Mack, Isabelle; Schellberg, Dieter; Müller-Stich, Beat Peter; Weiner, Rudolf; Meile, Tobias; Rudofsky, Gottfried; Königsrainer, Alfred; Zipfel, Stephan; Herzog, Wolfgang; Teufel, Martin

2015-01-01

For severely obese patients, bariatric surgery has been recommended as an effective therapy. The Bariataric Surgery and Education (BaSE) study aimed to assess the efficacy of a videoconferencing-based psychoeducational group intervention in patients after bariatric surgery. The BaSE study is a randomized, controlled multicenter clinical trial involving 117 patients undergoing bariatric surgery (mean preoperative body mass index [BMI] 49.9 kg/m(2), SD 6.4). Patients were enrolled between May 2009 and November 2012 and were randomly assigned to receive either conventional postsurgical visits or, in addition, a videoconferencing-based 1-year group program. Primary outcome measures were weight in kilograms, health-related quality of life (HRQOL), and general self-efficacy (GSE). Secondary outcome measures were depression symptoms and eating behavior. 94% of the patients completed the study. Mean weight loss for all patients was 45.9 kg (SD 16.4) 1 year after surgery (mean excess weight loss [EWL] 63%). Intention-to-treat analyses revealed no differences in weight loss, EWL, HRQOL, or self-efficacy between study groups at 1 year after surgery. However, patients with clinically significant depression symptoms (CSD) at baseline assigned to the intervention group (n = 29) had a significantly better HRQOL (P = .03), lower depression scores (P = .02), and a trend for a better EWL (.06) 1 year after surgery compared with the control group (n = 20). We could not prove the efficacy of the group program for the whole study sample. However, results indicate that the intervention is effective for the important subgroup of patients with CSD. Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial

Directory of Open Access Journals (Sweden)

Prchal Alice

2012-01-01

Full Text Available Abstract Background Since siblings of pediatric cancer patients are at risk for emotional, behavioral, and social problems, there is considerable interest in development of early psychological interventions. This paper aimed at evaluating the effectiveness of a two-session psychological intervention for siblings of newly diagnosed pediatric cancer patients. Methods Thirty siblings age 6-17 years were randomly assigned to an intervention group or an active control group with standard psychosocial care. The manualized intervention provided to siblings in the first 2 months after the cancer diagnosis of the ill child included medical information, promotion of coping skills, and a psychoeducational booklet for parents. At 4 to 6 weeks, 4 months, and 7 months after the diagnosis, all siblings and their parents completed measures (from standardized instruments of social support, quality of life, medical knowledge, posttraumatic stress symptoms, and anxiety. Results At follow-up siblings in the intervention group showed better psychological well-being, had better medical knowledge, and reported receiving social support from more people. However, the intervention had no effects on posttraumatic stress symptoms and anxiety. Conclusions The results of this pilot trial suggest that a two-session sibling intervention can improve siblings' adjustment, particularly psychological well-being, in the early stage after a cancer diagnosis. Trial Registration ClinicalTrials.gov NCT00296907

Elearning approaches to prevent weight gain in young adults: A randomized controlled study.

Science.gov (United States)

Nikolaou, Charoula Konstantia; Hankey, Catherine Ruth; Lean, Michael Ernest John

2015-12-01

Preventing obesity among young adults should be a preferred public health approach given the limited efficacy of treatment interventions. This study examined whether weight gain can be prevented by online approaches using two different behavioral models, one overtly directed at obesity and the other covertly. A three-group parallel randomized controlled intervention was conducted in 2012-2013; 20,975 young adults were allocated a priori to one control and two "treatment" groups. Two treatment groups were offered online courses over 19 weeks on (1) personal weight control ("Not the Ice Cream Van," NTICV) and, (2) political, environmental, and social issues around food ("Goddess Demetra," "GD"). Control group received no contact. The primary outcome was weight change over 40 weeks. Within-group 40-week weight changes were different between groups (P < 0.001): Control (n = 2,134): +2.0 kg (95% CI = 1.5, 2.3 kg); NTICV (n = 1,810): -1.0 kg (95% CI = -1.3, -0.5); and GD (n = 2,057): -1.35 kg (95% CI = -1.4 to -0.7). Relative risks for weight gain vs. NTICV = 0.13 kg (95% CI = 0.10, 0.15), P < 0.0001; GD = 0.07 kg (95% CI = 0.05, 0.10), P < 0.0001. Both interventions were associated with prevention of the weight gain observed among control subjects. This low-cost intervention could be widely transferable as one tool against the obesity epidemic. Outside the randomized controlled trial setting, it could be enhanced using supporting advertising and social media. © 2015 The Obesity Society.

Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial.

Science.gov (United States)

Shukla, Vivek V; Bansal, Satvik; Nimbalkar, Archana; Chapla, Apurva; Phatak, Ajay; Patel, Dipen; Nimbalkar, Somashekhar

2018-04-15

To compare individual efficacy and additive effects of pain control interventions in preterm neonates. Randomized controlled trial. Level-3 University affiliated neonatal intensive care unit. 200 neonates (26-36 wk gestational age) requiring heel-prick for bedside glucose assessment. Exclusion criteria were neurologic impairment and critical illness precluding study interventions. Neonates were randomly assigned to Kangaroo mother care with Music therapy, Music therapy, Kangaroo Mother care or Control (no additional intervention) groups. All groups received expressed breast milk with cup and spoon as a baseline pain control intervention. Assessment of pain using Premature Infant Pain Profile (PIPP) score on recorded videos. The mean (SD) birth weight and gestational age of the neonates was 1.9 (0.3) kg and 34 (2.3) wk, respectively. Analysis of variance showed significant difference in total PIPP score across groups (P<0.001). Post-hoc comparisons using Sheffe's test revealed that the mean (SD) total PIPP score was significantly lower in Kangaroo mother care group [7.7 (3.9) vs. 11.5 (3.4), 95% CI(-5.9, -1.7), P<0.001] as well as Kangaroo mother care with Music therapy group [8.5 (3.2) vs. 11.5 (3.4), 95%CI (-5.1, -0.9), P=0.001] as compared to Control group. PIPP score was not significantly different between Control group and Music therapy group. Kangaroo mother care with and without Music therapy (with expressed breast milk) significantly reduces pain on heel-prick as compared to expressed breast milk alone. Kangaroo mother care with expressed breast milk should be the first choice as a method for pain control in preterm neonates.

Two syringe spinal anesthesia technique for cesarean section: A controlled randomized study of a simple way to achieve more satisfactory block and less hypotension.

Science.gov (United States)

Keera, Amr Aly Ismail; Elnabtity, Ali Mohamed Ali

2016-01-01

Multiple trials have been tried to prevent hypotension during spinal anesthesia. However, the drug choice and mode of administration is still a matter of debate. To compare the outcome of spinal injection of hyperbaric bupivacaine and fentanyl separately to standard injection of mixed fentanyl with hyperbaric bupivacaine. A randomized, controlled clinical trial. One hundred twenty-four parturient scheduled for elective cesarean section were randomly allocated into two groups, each 62 parturient: Group M received spinal anesthesia using 10 mg bupivacaine 0.5% premixed with 25 μg fentanyl in the same syringe and Group S received 25 μg fentanyl in one syringe and 10 mg bupivacaine 0.5% without barbotage in a second syringe. Patients with intraoperative pain that was controllable without the need for a shift to general anesthesia was significantly lower in Group S (3.2%) than in Group M (16.1%). The frequency of hypotension was significantly lower in Group S compared to Group M (P 0.05). There was no significant difference in the time till occurrence of hypotension, duration of hypotension, mean dose of ephedrine used for the treatment of hypotension and frequency of patients developed itching between the groups (P > 0.05). Separate intrathecal injection of fentanyl and hyperbaric bupivacaine provided a significant improvement in the quality of sensory block and significant reduction of the frequency of hypotension compared to injection of mixed medications.

Effectiveness of preventive support groups for children of mentally ill or addicted parents: a randomized controlled trial.

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van Santvoort, Floor; Hosman, Clemens M H; van Doesum, Karin T M; Janssens, Jan M A M

2014-06-01

In various countries preventive support groups are offered to children of mentally ill and/or addicted parents to reduce the risk that they will develop problems themselves. This study assessed the effectiveness of Dutch support groups for children aged 8-12 years old in terms of reducing negative cognitions; improving social support, competence, and parent-child interaction (direct intervention goals); and reducing emotional and behavioural problems (ultimate intervention aim). Children from 254 families were randomly assigned to the intervention or a control condition. Parents and children completed questionnaires at baseline and 3 and 6 months later. Emotional and behavioural problems of intervention group children were also assessed 1 year after the start. Univariate analyses of variance showed that children in the intervention group experienced a greater decrease in negative cognitions and sought more social support, immediately after participation and 3 months later, as compared to control group children. They also remained stable in their feelings of social acceptance (competence aspect) immediately after the intervention, whereas these feelings declined in control group children. The intervention and control groups both improved over time in terms of cognitions, competence, parent-child interaction and emotional and behavioural problem scores. Additional improvement in terms of problem scores was found in the intervention group 1 year after baseline. Further enhancement of effectiveness requires re-consideration of the support group goals; it should be studied whether the goals reflect the most important and influential risk and protective factors for this specific population. Besides, effects should be studied over a longer period.

Acupuncture intervention in ischemic stroke: a randomized controlled prospective study.

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Shen, Peng-Fei; Kong, Li; Ni, Li-Wei; Guo, Hai-Long; Yang, Sha; Zhang, Li-Li; Zhang, Zhi-Long; Guo, Jia-Kui; Xiong, Jie; Zhen, Zhong; Shi, Xue-Min

2012-01-01

Stroke is one of the most common causes of death and few pharmacological therapies show benefits in ischemic stroke. In this study, 290 patients aged 40-75 years old with first onset of acute ischemic stroke (more than 24 hours but within 14 days) were treated with standard treatments, and then were randomly allocated into an intervention group (treated with resuscitating acupuncture) and a control group (treated using sham-acupoints). Primary outcome measures included Barthel Index (BI), relapse and death up to six months. For the 290 patients in both groups, one case in the intervention group died, and two cases in the control group died from the disease (p = 0.558). Six patients of the 144 cases in the intervention group had relapse, whereas 34 of 143 patients had relapse in the control group (p two groups, respectively (p two groups for the National Institute of Health Stroke Scale (NIHSS), not at two weeks (7.03 ± 3.201 vs. 8.13 ± 3.634; p = 0.067), but at four weeks (4.15 ± 2.032 vs. 6.35 ± 3.131, p Stroke Scale (CSS) at four weeks showed more improvement in the intervention group than that in the control group (9.40 ± 4.51 vs. 13.09 ± 5.80, p Stroke Specific Quality of Life Scale (SS-QOL) at six months was higher in the intervention group (166.63 ± 45.70) than the control group (143.60 ± 50.24; p < 0.01). The results of this clinical trial showed a clinically relevant decrease of relapse in patients treated with resuscitating acupuncture intervention by the end of six months, compared with needling at the sham-acupoints. The resuscitating acupuncture intervention could also improve self-care ability and quality of life, evaluated with BI, NIHSS, CSS, Oxford Handicap Scale (OHS), and SS-QOL.

Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

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Evelim L F D Gomes

Full Text Available The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma.A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20 or a treadmill group (TG; n = 16. Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO, maximum exercise testing (Bruce protocol and lung function.No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05. Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG.The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation.Clinicaltrials.gov NCT01438294.

Preventing Urinary Incontinence With Supervised Prenatal Pelvic Floor Exercises: A Randomized Controlled Trial.

Science.gov (United States)

Fritel, Xavier; de Tayrac, Renaud; Bader, Georges; Savary, Denis; Gueye, Ameth; Deffieux, Xavier; Fernandez, Hervé; Richet, Claude; Guilhot, Joëlle; Fauconnier, Arnaud

2015-08-01

To compare, in an unselected population of nulliparous pregnant women, the postnatal effect of prenatal supervised pelvic floor muscle training with written instructions on postpartum urinary incontinence (UI). In a randomized controlled trial in two parallel groups, 282 women were recruited from five university teaching hospitals in France and randomized during the second trimester of pregnancy. The physiotherapy group received prenatal individually supervised exercises. Both groups received written instructions about how to perform exercises at home. Women were blindly assessed at baseline, end of pregnancy, and 2 and 12 months postpartum. The primary outcome measured was UI severity, assessed with an International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score (range 0-21; 1-5 is slight UI) at 12 months postpartum; other outcomes were UI prevalence and pelvic floor troubles assessed using self-administered questionnaires. To give a 1-point difference in UI severity score, we needed 91 women in each group (standard deviation 2.4, α=0.05, β=0.20, and bilateral analysis). Between February 2008 and June 2010, 140 women were randomized in the physiotherapy group and 142 in the control group. No difference was observed between the two groups in UI severity, prevalence, or pelvic floor troubles at baseline, end of pregnancy, and at 2 and 12 months postpartum. At 12 months postpartum, the primary outcome was available for 190 women (67.4%); mean UI severity was 1.9 in the physiotherapy group compared with 2.1 in the control group (P=.38). Prenatal supervised pelvic floor training was not superior to written instructions in reducing postnatal UI. ClinicalTrials.gov; www.clinicaltrials.gov, NCT00551551. I.

An intervention to reduce HIV risk behavior of substance-using men who have sex with men: a two-group randomized trial with a nonrandomized third group.

Directory of Open Access Journals (Sweden)

Gordon Mansergh

2010-08-01

Full Text Available Substance use during sex is associated with sexual risk behavior among men who have sex with men (MSM, and MSM continue to be the group at highest risk for incident HIV in the United States. The objective of this study is to test the efficacy of a group-based, cognitive-behavioral intervention to reduce risk behavior of substance-using MSM, compared to a randomized attention-control group and a nonrandomized standard HIV-testing group.Participants (n = 1,686 were enrolled in Chicago, Los Angeles, New York City, and San Francisco and randomized to a cognitive-behavioral intervention or attention-control comparison. The nonrandomized group received standard HIV counseling and testing. Intervention group participants received six 2-h group sessions focused on reducing substance use and sexual risk behavior. Attention-control group participants received six 2-h group sessions of videos and discussion of MSM community issues unrelated to substance use, sexual risk, and HIV/AIDS. All three groups received HIV counseling and testing at baseline. The sample reported high-risk behavior during the past 3 mo prior to their baseline visit: 67% reported unprotected anal sex, and 77% reported substance use during their most recent anal sex encounter with a nonprimary partner. The three groups significantly (p0.05 from each other at 3-, 6-, and 12-mo follow-up. Outcomes for the 2-arm comparisons were not significantly different at 12-mo follow-up (e.g., unprotected anal sex, odds ratio = 1.14, confidence interval = 0.86-1.51, nor at earlier time points. Similar results were found for each outcome variable in both 2- and 3-arm comparisons.These results for reducing sexual risk behavior of substance-using MSM are consistent with results of intervention trials for other populations, which collectively suggest critical challenges for the field of HIV behavioral interventions. Several mechanisms may contribute to statistically indistinguishable reductions in risk

A Preliminary Investigation of a Randomized Dependent Group Contingency for Hallway Transitions

Science.gov (United States)

Deshais, Meghan A.; Fisher, Alyssa B.; Kahng, SungWoo

2018-01-01

We conducted a preliminary investigation of a randomized dependent group contingency to decrease disruptive behavior during hallway transitions. Two first-graders, identified by their classroom teacher, participated in this study. A multiple baseline across transitions was used to evaluate the effects of the randomized dependent group contingency…

Autoshaping, random control, and omission training in the rat.

Science.gov (United States)

Locurto, C; Terrace, H S; Gibbon, J

1976-11-01

The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping.

Randomized controlled trial of a comprehensive stroke education program for patients and caregivers.

Science.gov (United States)

Rodgers, H; Atkinson, C; Bond, S; Suddes, M; Dobson, R; Curless, R

1999-12-01

We report the findings of a randomized controlled trial to determine the effectiveness of a multidisciplinary Stroke Education Program (SEP) for patients and their informal carers. Two hundred four patients admitted with acute stroke and their 176 informal carers were randomized to receive an invitation to the SEP or to receive conventional stroke unit care. The SEP consisted of one 1-hour small group educational session for inpatients followed by six 1-hour sessions after discharge. The primary outcome measure was patient- and carer-perceived health status (SF-36) at 6 months after stroke. Knowledge of stroke, satisfaction with services, emotional outcome, disability, and handicap and were secondary outcome measures. Only 51 of 108 (47%) surviving patients randomized to the SEP completed the program, as did 20 of 93 (22%) informal carers of surviving patients. Perceived health status (Short Form 36 [SF-36] health survey) scores were similar for SEP patients and controls. Informal carers in the control group scored better on the social functioning component of the SF-36 than the SEP group (P=0.04). Patients and informal carers in the SEP group scored higher on the stroke knowledge scale than controls (patients, P=0.02; carers, P=0. 01). Patients in the SEP group were more satisfied with the information that they had received about stroke (P=0.004). There were no differences in emotional or functional outcomes between groups. Although the SEP improved patient and informal carer knowledge about stroke and patient satisfaction with some components of stroke services, this was not associated with an improvement in their perceived health status. Indeed, the social functioning of informal carers randomized to the SEP was less than in the control group.

A group randomized controlled trial integrating obesity prevention and control for postpartum adolescents in a home visiting program.

Science.gov (United States)

Haire-Joshu, Debra L; Schwarz, Cynthia D; Peskoe, Sarah B; Budd, Elizabeth L; Brownson, Ross C; Joshu, Corinne E

2015-06-26

Adolescence represents a critical period for the development of overweight that tracks into adulthood. This risk is significantly heightened for adolescents that become pregnant, many of whom experience postpartum weight retention. The aim of this study was to evaluate Balance Adolescent Lifestyle Activities and Nutrition Choices for Energy (BALANCE), a multicomponent obesity prevention intervention targeting postpartum adolescents participating in a national home visiting child development-parent education program. A group randomized, nested cohort design was used with 1325 adolescents, 694 intervention and 490 control, (mean age = 17.8 years, 52 % underrepresented minorities) located across 30 states. Participatory methods were used to integrate lifestyle behavior change strategies within standard parent education practice. Content targeted replacement of high-risk obesogenic patterns (e.g. sweetened drink and high fat snack consumption, sedentary activity) with positive behaviors (e.g. water intake, fruit and vegetables, increased walking). Parent educators delivered BALANCE through home visits, school based classroom-group meetings, and website activities. Control adolescents received standard child development information. Phase I included baseline to posttest (12 months); Phase II included baseline to follow-up (24 months). When compared to the control group, BALANCE adolescents who were ≥12 weeks postpartum were 89 % more likely (p = 0.02) to maintain a normal BMI or improve an overweight/obese BMI by 12 months; this change was not sustained at 24 months. When compared to the control group, BALANCE adolescents significantly improved fruit and vegetable intake (p = .03). In stratified analyses, water intake improved among younger BALANCE teens (p = .001) and overweight/obese BALANCE teens (p = .05) when compared to control counterparts. There were no significant differences between groups in sweetened drink and snack consumption

Controllable group velocity of the probe light in a Λ-type system with two fold levels

International Nuclear Information System (INIS)

Jin Lihui; Gong Shangqing; Niu Yueping; Li Ruxin; Jin Shiqi

2006-01-01

The group velocities of the probe laser field are studied in a Λ-type system where one lower state has two fold levels coupled by a control field. It is found that the interaction of double dark states leads to controllable group velocity of the probe field in this system. It can be easily realized, due to the interacting double dark resonances, that one of the group velocities at transparency positions is much slower than the other by tuning the control field to be off resonance. In particular, when the control field is on resonance, we can obtain two equal slow group velocities with a broader EIT width, which provides potential applications in quantum storage and retrieval of light

Restorations in abrasion/erosion cervical lesions: 8-year results of a triple blind randomized controlled trial.

Science.gov (United States)

Dall'Orologio, Giovanni Dondi; Lorenzi, Roberta

2014-10-01

An equivalence randomized controlled trial within the subject was organized to evaluate the clinical long-term success of a new 2-step etch & rinse adhesive and a new nano-filled ormocer. 50 subjects, 21 males and 29 females aged between 21 and 65, were randomized to receive 150 restorations, 100 with the new restorative material, 50 with the composite as control, placed in non-carious cervical lesions with the same bonding system. The main outcome measure was the cause of failure at 8 years. Randomization was number table-generated, with allocation concealment by opaque sequentially numbered sealed and stapled envelopes. Subjects, examiner, and analyst were blinded to group assignment. Two interim analyses were performed. Data were analyzed by ANOVA and Cox test (P failures in the experimental group and four failures in the control group. The cumulative loss rate was 7% for both restorative materials, with the annual failure lower than 1%, without any statistically significant difference. There were two key elements of failure: the presence of sclerotic dentin and the relationship between lesion and gingival margin.

The Challenge of Recruiting Control Groups

DEFF Research Database (Denmark)

O'Connor, Maja

2011-01-01

. This study was a direct reaction to the first recruitment attempt that had a 10% response rate. This study consisted of four groups of randomly selected elderly married people (65-81 years) receiving a postal questionnaire measuring depression, social support, coping style, adult attachment, life......  Recruitment of a large and reliable control group is a challenge in psychological survey based research. The effect of recruitment styles and age on response-rate, data quality, and individual differences were investigated in a control group for a postal survey of elderly bereaved people...... incentive had the highest response-rate (51%), good data quality, and no sampling bias in individual differences. This method can be highly recommended in future control group recruitment....

Antenatal hypnosis training and childbirth experience: a randomized controlled trial.

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Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Wu, Chun Sen; Nohr, Ellen A

2013-12-01

Childbirth is a demanding event in a woman's life. The aim of this study was to explore whether a brief intervention in the form of an antenatal course in self-hypnosis to ease childbirth could improve the childbirth experience. In a randomized, controlled, single-blinded trial, 1,222 healthy nulliparous women were allocated to one of three groups during pregnancy: A hypnosis group participating in three 1-hour sessions teaching self-hypnosis to ease childbirth, a relaxation group receiving three 1-hour lessons in various relaxation methods and Mindfulness, and a usual care group receiving ordinary antenatal care only. Wijmas Delivery Expectancy/Experience Questionnaire (W-DEQ) was used to measure the childbirth experience 6 weeks postpartum. The intention-to-treat analysis indicated that women in the hypnosis group experienced their childbirth as better compared with the other two groups (mean W-DEQ score of 42.9 in the Hypnosis group, 47.2 in the Relaxation group, and 47.5 in the Care as usual group (p = 0.01)). The tendency toward a better childbirth experience in the hypnosis group was also seen in subgroup analyses for mode of delivery and for levels of fear. In this large randomized controlled trial, a brief course in self-hypnosis improved the women's childbirth experience. © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.

A randomized controlled trial of an electronic informed consent process.

Science.gov (United States)

Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

2014-12-01

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

A long-term self-managed handwriting intervention for people with Parkinson's disease: results from the control group of a phase II randomized controlled trial.

Science.gov (United States)

Collett, Johnny; Franssen, Marloes; Winward, Charlotte; Izadi, Hooshang; Meaney, Andy; Mahmoud, Wala; Bogdanovic, Marko; Tims, Martin; Wade, Derick; Dawes, Helen

2017-12-01

To report on the control group of a trial primarily designed to investigate exercise for improving mobility in people with Parkinson's disease (pwP). The control group undertook a handwriting intervention to control for attention and time spent practising a specific activity. Secondary analysis of a two-arm parallel phase II randomized controlled trial with blind assessment. Community. PwP able to walk ⩾100 m and with no contraindication to exercise were recruited from the Thames Valley, UK, and randomized (1:1) to exercise or handwriting, via a concealed computer-generated list. Handwriting was undertaken at home and exercise in community facilities; both were delivered through workbooks with monthly support visits and involved practice for 1 hour, twice weekly, over a period of six months. Handwriting was assessed, at baseline, 3, 6 and 12 months, using a pangram giving writing speed, amplitude (area) and progressive reduction in amplitude (ratio). The Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (UPDRS) item 2.7 measured self-reported handwriting deficits. In all, 105 pwP were recruited (analysed: n  = 51 handwriting, n  = 54 exercise). A total of 40 pwP adhered to the handwriting programme, most completing ⩾1 session/week. Moderate effects were found for amplitude (total area: d = 0.32; 95% confidence interval (CI): -0.11 to 0.7; P = 0.13) in favour of handwriting over a period of12 months; effects for writing speed and ratio parameters were small ≤0.11. Self-reported handwriting difficulties also favoured handwriting (UPDRS 2.7: odds ratio (OR) = 0.55; 95% CI: 0.34 to 0.91; P = 0.02). No adverse effects were reported. PwP generally adhere to self-directed home handwriting which may provide benefit with minimal risk. Encouraging effects were found in writing amplitude and, moreover, perceived ability.

Group versus individual family planning counseling in Ghana: a randomized, noninferiority trial.

Science.gov (United States)

Schwandt, Hilary M; Creanga, Andreea A; Danso, Kwabena A; Adanu, Richard M K; Agbenyega, Tsiri; Hindin, Michelle J

2013-08-01

Group, rather than individual, family planning counseling has the potential to increase family planning knowledge and use through more efficient use of limited human resources. A randomized, noninferiority study design was utilized to identify whether group family planning counseling is as effective as individual family planning counseling in Ghana. Female gynecology patients were enrolled from two teaching hospitals in Ghana in June and July 2008. Patients were randomized to receive either group or individual family planning counseling. The primary outcome in this study was change in modern contraceptive method knowledge. Changes in family planning use intention before and after the intervention and intended method type were also explored. Comparisons between the two study arms suggest that randomization was successful. The difference in change in modern contraceptive methods known from baseline to follow-up between the two study arms (group-individual), adjusted for study site, was -0.21, (95% confidence interval: -0.53 to 0.12) suggesting no difference between the two arms. Group family planning counseling was as effective as individual family planning counseling in increasing modern contraceptive knowledge among female gynecology patients in Ghana. Copyright © 2013 Elsevier Inc. All rights reserved.

Competency-Based Training and Worker Turnover in Community Supports for People With IDD: Results From a Group Randomized Controlled Study.

Science.gov (United States)

Bogenschutz, Matthew; Nord, Derek; Hewitt, Amy

2015-06-01

Turnover among direct support professionals (DSPs) in community support settings for individuals with intellectual and developmental disabilities (IDD) has been regarded as a challenge since tracking of this workforce began in the 1980s. This study utilized a group randomized controlled design to test the effects of a competency-based training intervention for DSPs on site-level turnover rates over a one year period. Results suggested that, compared with the control group, sites receiving the training intervention experienced a significant decrease in annual turnover, when multiple factors were controlled. Implications, including the importance of considering quality training as a long term organizational investment and intervention to reduce turnover, are discussed.

The effect of vitamin D on primary dysmenorrhea with vitamin D deficiency: a randomized double-blind controlled clinical trial.

Science.gov (United States)

Moini, Ashraf; Ebrahimi, Tabandeh; Shirzad, Nooshin; Hosseini, Reihaneh; Radfar, Mania; Bandarian, Fatemeh; Jafari-Adli, Shahrzad; Qorbani, Mostafa; Hemmatabadi, Mahboobeh

2016-06-01

Dysmenorrhea is common among women of reproductive age. This study aim was to investigate the effect of vitamin D (vit D) supplementation in treatment of primary dysmenorrhea with vit D deficiency. A randomized double-blind placebo-controlled clinical trial was conducted on 60 women with primary dysmenorrhea and vit D deficiency referred to our clinic at Arash Women's Hospital from September 2013 to December 2014. Eligible women were randomly assigned into treatment and control groups (30 in each group). Individuals in the treatment group received 50 000 IU oral vit D and the control group received placebo weekly for eight weeks. After two months of treatment, there was a significant difference in serum vit D concentration between the two groups (p dysmenorrhea and vit D deficiency could improve pain intensity.

Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention

Directory of Open Access Journals (Sweden)

Hadi Yousefi

2015-11-01

Full Text Available OBJECTIVES: Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA. METHODS: Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS, patient general health (GH on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. RESULTS: The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%, tobacco usage (25% vs. 19.8%, mean age (42.6±13.2 years vs. 46.6±10.9 years, and disease duration (15.3±6.7 months vs. 14.5±6.6 months. The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. CONCLUSIONS: Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities.

The effectiveness of peer support groups in psychosis : a randomized controlled trial

NARCIS (Netherlands)

Castelein, S.; Bruggeman, R.; van Busschbach, J. T.; van der Gaag, M.; Stant, A. D.; Knegtering, H.; Wiersma, D.

Objective: To investigate the effect of a (minimally) guided peer support group (GPSG) for people with psychosis on social network, social support, self-efficacy, self-esteem, and quality of life, and to evaluate the intervention and its economic consequences. Method: In a multi-center randomized

The effectiveness of a Group Triple P with Chinese parents who have a child with developmental disabilities: a randomized controlled trial.

Science.gov (United States)

Leung, Cynthia; Fan, Angel; Sanders, Matthew R

2013-03-01

The study examined the effectiveness of Group Triple P, a Level 4 variant of the Triple P multilevel system of parenting support, with Chinese parents who had a preschool aged child with a developmental disability, using randomized controlled trial design. Participants (Intervention group: 42; Waitlist Control group: 39) completed measures on child behaviour, parental stress, dysfunctional discipline styles and parental conflict before and after program completion by the Intervention group. Intervention group participants also completed these same measures six months after program completion. Compared to the Waitlist Control group, parents receiving Group Triple P reported significantly lower levels of child behaviour problems, parental stress, dysfunctional discipline style and parental conflict scores. The Intervention group participants maintained their gains six months after program completion. The results provided promising evidence for the Level 4 Group Triple P as an effective intervention program for Chinese parents who have preschool aged children with developmental disabilities. Copyright © 2012 Elsevier Ltd. All rights reserved.

The effectiveness of core stabilization exercise in adolescent idiopathic scoliosis: A randomized controlled trial.

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Gür, Gözde; Ayhan, Cigdem; Yakut, Yavuz

2017-06-01

Core stabilization training is used to improve postural balance in musculoskeletal problems. The purpose of this study was to investigate the effectiveness of stabilization training in adolescent idiopathic scoliosis. A randomized controlled trial, pretest-posttest design. In total, 25 subjects with adolescent idiopathic scoliosis were randomly divided into two groups: stabilization group ( n = 12) and control group ( n = 13). The stabilization group received core stabilization in addition to traditional rehabilitation, and the control group received traditional rehabilitation for 10 weeks. Assessment included Cobb's angle on radiograph, apical vertebral rotation in Adam's test, trunk asymmetry (Posterior Trunk Symmetry Index), cosmetic trunk deformity (Trunk Appearance Perception Scale), and quality of life (Scoliosis Research Society-22 questionnaire). Inter-group comparisons showed significantly greater improvements in the mean change in lumbar apical vertebral rotation degree and the pain domain of Scoliosis Research Society-22 in the stabilization group than those in the control group ( p adolescent idiopathic scoliosis. Clinical relevance Stabilization exercises are more effective in reducing rotation deformity and pain than traditional exercises in the conservative rehabilitation of adolescent idiopathic scoliosis. These improvements suggest that stabilization training should be added to rehabilitation programs in adolescent idiopathic scoliosis.

Groups, graphs and random walks

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Salvatori, Maura; Sava-Huss, Ecaterina

2017-01-01

An accessible and panoramic account of the theory of random walks on groups and graphs, stressing the strong connections of the theory with other branches of mathematics, including geometric and combinatorial group theory, potential analysis, and theoretical computer science. This volume brings together original surveys and research-expository papers from renowned and leading experts, many of whom spoke at the workshop 'Groups, Graphs and Random Walks' celebrating the sixtieth birthday of Wolfgang Woess in Cortona, Italy. Topics include: growth and amenability of groups; Schrödinger operators and symbolic dynamics; ergodic theorems; Thompson's group F; Poisson boundaries; probability theory on buildings and groups of Lie type; structure trees for edge cuts in networks; and mathematical crystallography. In what is currently a fast-growing area of mathematics, this book provides an up-to-date and valuable reference for both researchers and graduate students, from which future research activities will undoubted...

Velocity and Dispersion for a Two-Dimensional Random Walk

International Nuclear Information System (INIS)

Li Jinghui

2009-01-01

In the paper, we consider the transport of a two-dimensional random walk. The velocity and the dispersion of this two-dimensional random walk are derived. It mainly show that: (i) by controlling the values of the transition rates, the direction of the random walk can be reversed; (ii) for some suitably selected transition rates, our two-dimensional random walk can be efficient in comparison with the one-dimensional random walk. Our work is motivated in part by the challenge to explain the unidirectional transport of motor proteins. When the motor proteins move at the turn points of their tracks (i.e., the cytoskeleton filaments and the DNA molecular tubes), some of our results in this paper can be used to deal with the problem. (general)

The effects of mirror therapy on the gait of subacute stroke patients: a randomized controlled trial.

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Ji, Sang Gu; Kim, Myoung Kwon

2015-04-01

To investigate the effect of mirror therapy on the gait of patients with subacute stroke. Randomized controlled experimental study. Outpatient rehabilitation hospital. Thirty-four patients with stroke were randomly assigned to two groups: a mirror therapy group (experimental) and a control group. The stroke patients in the experimental group underwent comprehensive rehabilitation therapy and mirror therapy for the lower limbs. The stroke patients in the control group underwent sham therapy and comprehensive rehabilitation therapy. Participants in both groups received therapy five days per week for four weeks. Temporospatial gait characteristics, such as single stance, stance phase, step length, stride, swing phase, velocity, and cadence, were assessed before and after the four weeks therapy period. A significant difference was observed in post-training gains for the single stance (10.32 SD 4.14 vs. 6.54 SD 3.23), step length (8.47 SD 4.12 vs. 4.83 SD 2.14), and stride length (17.03 SD 6.57 vs 10.54 SD 4.34) between the experimental group and the control group (p two groups on stance phase, swing phase, velocity, cadence, and step width (P > 0.05). We conclude that mirror therapy may be beneficial in improving the effects of stroke on gait ability. © The Author(s) 2014.

Web app based patient education in psoriasis - a randomized controlled trial.

Science.gov (United States)

Hawkins, Spencer D; Barilla, Steven; Feldman, Steven R

2017-04-15

Patients report wanting more information about psoriasis and clear expectations from the onset of therapy. Dermatologists do not think patients receive or internalize adequate information. There isa need for further explanation of treatment regimens to increase knowledge, compliance, and patient satisfaction. Recent advancements in web technology have the potential to improve these psoriasis outcomes. A web based application was created to educate psoriasis patients using video, graphics, and textual information. An investigator blinded, randomized, controlled study evaluated the website's efficacy in 50 psoriasis patients at Wake Forest Baptist Health Dermatology. Patients were randomized into two groups: Group 1 received a link to the educational web app and a survey following their visit; Group 2 received a link to the survey with no educational web app. The survey assessed patient knowledge, self reported adherence to medication, and adequacy of addressing concerns. Twenty two patients completed the study. Patients in the web app group scored an average of 11/14 on the psoriasis knowledge quiz, whereas patients in the control group scored an average of 9/14 for an improvement of roughly 18% (p=0.008, n=22). Web app based education via DermPatientEd.Com is an efficient way to improve knowledge, but we did not demonstrate improvements in self-reported medication adherence or the ability to address concerns of psoriasis patients.

The effects of two health information texts on patient recognition memory: a randomized controlled trial.

Science.gov (United States)

Freed, Erin; Long, Debra; Rodriguez, Tonantzin; Franks, Peter; Kravitz, Richard L; Jerant, Anthony

2013-08-01

To compare the effects of two health information texts on patient recognition memory, a key aspect of comprehension. Randomized controlled trial (N=60), comparing the effects of experimental and control colorectal cancer (CRC) screening texts on recognition memory, measured using a statement recognition test, accounting for response bias (score range -0.91 to 5.34). The experimental text had a lower Flesch-Kincaid reading grade level (7.4 versus 9.6), was more focused on addressing screening barriers, and employed more comparative tables than the control text. Recognition memory was higher in the experimental group (2.54 versus 1.09, t=-3.63, P=0.001), including after adjustment for age, education, and health literacy (β=0.42, 95% CI: 0.17, 0.68, P=0.001), and in analyses limited to persons with college degrees (β=0.52, 95% CI: 0.18, 0.86, P=0.004) or no self-reported health literacy problems (β=0.39, 95% CI: 0.07, 0.71, P=0.02). An experimental CRC screening text improved recognition memory, including among patients with high education and self-assessed health literacy. CRC screening texts comparable to our experimental text may be warranted for all screening-eligible patients, if such texts improve screening uptake. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Efficacy of individualized social competence training for children with oppositional defiant disorders/conduct disorders: a randomized controlled trial with an active control group.

Science.gov (United States)

Goertz-Dorten, Anja; Benesch, Christina; Berk-Pawlitzek, Emel; Faber, Martin; Hautmann, Christopher; Hellmich, Martin; Lindenschmidt, Timo; Schuh, Lioba; Stadermann, Rahel; Doepfner, Manfred

2018-03-28

Patient-focused cognitive-behavioral therapy in children with aggressive behavior, which uses group-based social skills training, has resulted in significant reductions in behavioral problems, with effect sizes in the small-to-medium range. However, effects of individually delivered treatments and effects on aggressive behavior and comorbid conditions rated from different perspectives, child functional impairment, child quality of life, parent-child relationship, and parental psychopathology have rarely been assessed. In a randomized controlled trial, 91 boys aged 6-12 years with a diagnosis of oppositional defiant disorder/conduct disorder and peer-related aggression were randomized to receive individually delivered social competence training (Treatment Program for Children with Aggressive Behavior, THAV) or to an active control involving group play that included techniques to activate resources and the opportunity to train prosocial interactions in groups (PLAY). Outcome measures were rated by parents, teachers, or clinicians. Mostly moderate treatment effects for THAV compared to PLAY were found in parent ratings and/or clinician ratings on aggressive behavior, comorbid symptoms, psychosocial impairment, quality of life, parental stress, and negative expressed emotions. In teacher ratings, significant effects were found for ADHD symptoms and prosocial behavior only. THAV is a specifically effective intervention for boys aged 6-12 years with oppositional defiant disorder/conduct disorder and peer-related aggressive behavior as rated by parents and clinicians.

The effects of holistic health group interventions on improving the cognitive ability of persons with mild cognitive impairment: a randomized controlled trial

Science.gov (United States)

Young, Kim-wan; Ng, Petrus; Kwok, Timothy; Cheng, Daphne

2017-01-01

Purpose Persons with mild cognitive impairment (PwMCI) are at a higher risk of developing dementia than those without cognitive impairment. This research study aims to evaluate the effectiveness of a holistic health group intervention, which is based on the holistic brain health approach as well as an Eastern approach to health care, on improving the cognitive ability of Chinese PwMCI. Research methods In a randomized controlled trial (RCT), 38 Chinese PwMCI were randomly assigned to either a 10-session holistic health intervention group or the control group. The holistic health treatment group attempted to promote the acceptance of their illness, enhance memory and coping skills, develop a positive lifestyle, maintain positive emotions, and facilitate emotional support among participants. The 10-session holistic health group intervention was structured, with each session conducted once per week and ~90 minutes in length. Control group patients and their family caregivers received standardized basic educational materials that provided basic information on cognitive decline for them to read at home. The Montreal Cognitive Assessment (MoCA) test was used to assess the cognitive ability of PwMCI in the pre- and posttreatment periods by a research assistant who was blind to the group assignment of the participants. Results The paired-samples t-test indicated that the treatment group (n=18) showed significant improvement in the MoCA score, whereas the control group (n=20) did not. Moreover, 2×2 (group × time) repeated-measures analysis of covariance (ANCOVA) demonstrated that the holistic health group treatment was significantly more effective than the control intervention in improving the MoCA score, with a moderate effect size, and improving the delayed recall (ie, short-term memory), with a strong effect size, after controlling for age, sex, education, and marital status. Conclusion This present RCT provides evidence to support the feasibility and effectiveness of

The effects of holistic health group interventions on improving the cognitive ability of persons with mild cognitive impairment: a randomized controlled trial.

Science.gov (United States)

Young, Kim-Wan; Ng, Petrus; Kwok, Timothy; Cheng, Daphne

2017-01-01

Persons with mild cognitive impairment (PwMCI) are at a higher risk of developing dementia than those without cognitive impairment. This research study aims to evaluate the effectiveness of a holistic health group intervention, which is based on the holistic brain health approach as well as an Eastern approach to health care, on improving the cognitive ability of Chinese PwMCI. In a randomized controlled trial (RCT), 38 Chinese PwMCI were randomly assigned to either a 10-session holistic health intervention group or the control group. The holistic health treatment group attempted to promote the acceptance of their illness, enhance memory and coping skills, develop a positive lifestyle, maintain positive emotions, and facilitate emotional support among participants. The 10-session holistic health group intervention was structured, with each session conducted once per week and ~90 minutes in length. Control group patients and their family caregivers received standardized basic educational materials that provided basic information on cognitive decline for them to read at home. The Montreal Cognitive Assessment (MoCA) test was used to assess the cognitive ability of PwMCI in the pre- and posttreatment periods by a research assistant who was blind to the group assignment of the participants. The paired-samples t -test indicated that the treatment group (n=18) showed significant improvement in the MoCA score, whereas the control group (n=20) did not. Moreover, 2×2 (group × time) repeated-measures analysis of covariance (ANCOVA) demonstrated that the holistic health group treatment was significantly more effective than the control intervention in improving the MoCA score, with a moderate effect size, and improving the delayed recall (ie, short-term memory), with a strong effect size, after controlling for age, sex, education, and marital status. This present RCT provides evidence to support the feasibility and effectiveness of the holistic health group intervention in

Comparison of post-obturation pain experience following one-visit and two-visit root canal treatment on teeth with vital pulps: a randomized controlled trial.

Science.gov (United States)

Wang, C; Xu, P; Ren, L; Dong, G; Ye, L

2010-08-01

To compare the incidence and intensity of post-obturation pain after one- or two-visit root canal treatment (RCT) on anterior teeth with vital pulps and a single root and canal in a randomized controlled trial. One hundred patients requiring RCT on permanent anterior teeth with vital pulps preoperatively were included. The patients were assigned randomly into two groups of 50 patients each. After local anaesthesia, isolation, access and pulp extirpation, the canals of all teeth were prepared using engine-driven rotary ProTaper nickel-titanium instruments in a crown-down technique and irrigated with 2.5% NaOCl. The teeth in group 1 (n = 50) were filled with AH Plus sealer and gutta-percha using a lateral compaction technique at the first visit, whilst those in group 2 (n = 50) were medicated with a calcium hydroxide paste, a sterile dry cotton pellet and Caviton and scheduled for a second visit 7 days later. A modified verbal descriptor scale was used to measure preoperative pain and post-obturation pain at 6, 24, 48 h and 1 week after operation. Chi-square tests and independent-sample T-tests were used to compare the incidence and intensity of post-obturation pain of two groups at each interval. Eleven patients were excluded from the study as they failed to follow the scheduled revisit or their selected teeth had more than one root canal. Data were obtained from the remaining 89 patients. Forty-three patients were undergoing one-visit treatment (group 1) and 46 undergoing two-visit treatment (group 2). Most patients in both groups reported no pain or only slight pain within each post-obturation interval, only one in group 1 and one in group 2 had flare-ups and slight swelling. There was no statistically significant difference in the incidence and intensity of post-obturation pain experienced by two groups. The incidence and intensity of post-obturation pain experience following one- or two-visit RCT on teeth with vital pulps and a single canal were not

Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial.

Science.gov (United States)

Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J

2017-01-01

Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.

Fast Neutron Radiotherapy for Locally Advanced Prostate Cancer: Final Report of a Radiation Therapy Oncology Group Randomized Clinical Trial

Energy Technology Data Exchange (ETDEWEB)

Laramore, G. E.; Krall, J. M.; Thomas, F. J.; Russell, K. J.; Maor, M. H.; Hendrickson, F. R.; Martz, K. L.; Griffin, T. W.; Davis, L. W.

1993-01-01

Between June 1977 and April 1983 the Radiation Therapy Oncology Group (RTOG) sponsored a Phase III randomized trial investigating the use of fast neutron radiotherapy for patients with locally advanced (Stages C and D1) adenocarcinoma of the prostate gland. Patients were randomized to receive either conventional photon radiation or fast neutron radiation used in a mixed-beam (neutron/photon) treatment schedule. A total of 91 analyzable patients were entered into the study, and the two patient groups were balanced with respect to the major prognostic variables. Actuarial curves are presented for local/regional control and "overall" survival. Ten-year results for clinically assessed local control are 70% for the mixed-beam group versus 58% for the photon group (p = 0.03) and for survival are 46% for the mixed-beam group versus 29% for the photon group (p = 0.04). This study suggests that a regional method of treatment can influence both local tumor control and survival in patients with locally advanced adenocarcinoma of the prostate gland.

After-School Multifamily Groups: A Randomized Controlled Trial Involving Low-Income, Urban, Latino Children

Science.gov (United States)

McDonald, Lynn; Moberg, D. Paul; Brown, Roger; Rodriguez-Espiricueta, Ismael; Flores, Nydia I.; Burke, Melissa P.; Coover, Gail

2006-01-01

This randomized controlled trial evaluated a culturally representative parent engagement strategy with Latino parents of elementary school children. Ten urban schools serving low-income children from mixed cultural backgrounds participated in a large study. Classrooms were randomly assigned either either to an after-school, multifamily support…

Simulation can contribute a part of cardiorespiratory physiotherapy clinical education: two randomized trials.

Science.gov (United States)

Blackstock, Felicity C; Watson, Kathryn M; Morris, Norman R; Jones, Anne; Wright, Anthony; McMeeken, Joan M; Rivett, Darren A; O'Connor, Vivienne; Peterson, Raymond F; Haines, Terry P; Watson, Geoffrey; Jull, Gwendolen Anne

2013-02-01

Simulated learning environments (SLEs) are used worldwide in health professional education, including physiotherapy, to train certain attributes and skills. To date, no randomized controlled trial (RCT) has evaluated whether education in SLEs can partly replace time in the clinical environment for physiotherapy cardiorespiratory practice. Two independent single-blind multi-institutional RCTs were conducted in parallel using a noninferiority design. Participants were volunteer physiotherapy students (RCT 1, n = 176; RCT 2, n = 173) entering acute care cardiorespiratory physiotherapy clinical placements. Two SLE models were investigated as follows: RCT 1, 1 week in SLE before 3 weeks of clinical immersion; RCT 2, 2 weeks of interspersed SLE/clinical immersion (equivalent to 1 SLE week) within the 4-week clinical placement. Students in each RCT were stratified on academic grade and randomly allocated to an SLE plus clinical immersion or clinical immersion control group. The primary outcome was competency to practice measured in 2 clinical examinations using the Assessment of Physiotherapy Practice. Secondary outcomes were student perception of experience and clinical educator and patient rating of student performance. There were no significant differences in student competency between the SLE and control groups in either RCT, although students in the interspersed group (RCT 2) achieved a higher score in 5 of 7 Assessment of Physiotherapy Practice standards (all P Students rated the SLE experience positively. Clinical educators and patients reported comparability between groups. An SLE can replace clinical time in cardiorespiratory physiotherapy practice. Part education in the SLE satisfied clinical competency requirements, and all stakeholders were satisfied.

Optimizing Gestational Weight Gain With the Eating4Two Smartphone App: Protocol for a Randomized Controlled Trial.

Science.gov (United States)

Davis, Deborah; Davey, Rachel; Williams, Lauren T; Foureur, Maralyn; Nohr, Ellen; Knight-Agarwal, Catherine; Lawlis, Tanya; Oats, Jeremy; Skouteris, Helen; Fuller-Tyszkiewicz, Matthew

2018-05-30

Approximately 50% of women gain excessive weight in pregnancy. Optimizing gestational weight gain is important for the short- and long-term health of the childbearing woman and her baby. Despite this, there is no recommendation for routine weighing in pregnancy, and weight is a topic that many maternity care providers avoid. Resource-intensive interventions have mainly targeted overweight and obese women with variable results. Few studies have examined the way that socioeconomic status might influence the effectiveness or acceptability of an intervention to participants. Given the scale of the problem of maternal weight gain, maternity services will be unlikely to sustain resource intensive interventions; therefore, innovative strategies are required to assist women to manage weight gain in pregnancy. The primary aim of the trial was to examine the effectiveness of the Eating4Two smartphone app in assisting women of all body mass index categories to optimize gestational weight gain. Secondary aims include comparing childbirth outcomes and satisfaction with antenatal care and examining the way that relative advantage and disadvantage might influence engagement with and acceptability of the intervention. This randomized controlled trial will randomize 1330 women to control or intervention groups in 3 regions of different socioeconomic status. Women will be recruited from clinical and social media sites. The intervention group will be provided with access to the Eating4Two mobile phone app which provides nutrition and dietary information specifically tailored for pregnancy, advice on food serving sizes, and a graph that illustrates women's weight change in relation to the range recommended by the Institute of Medicine. Women will be encouraged to use the app to prompt conversations with their maternity care providers about weight gain in pregnancy. The control group will receive routine antenatal care. Recruitment has commenced though the recruitment rate is slower

Can the Onset of Type 2 Diabetes Be Delayed by a Group-Based Lifestyle Intervention in Women with Prediabetes following Gestational Diabetes Mellitus (GDM)? Findings from a Randomized Control Mixed Methods Trial.

Science.gov (United States)

O'Dea, Angela; Tierney, Marie; McGuire, Brian E; Newell, John; Glynn, Liam G; Gibson, Irene; Noctor, Eoin; Danyliv, Andrii; Connolly, Susan B; Dunne, Fidelma P

2015-01-01

To evaluate a 12-week group-based lifestyle intervention programme for women with prediabetes following gestational diabetes (GDM). A two-group, mixed methods randomized controlled trial in which 50 women with a history of GDM and abnormal glucose tolerance postpartum were randomly assigned to intervention (n = 24) or wait control (n = 26) and postintervention qualitative interviews with participants. Modifiable biochemical, anthropometric, behavioural, and psychosocial risk factors associated with the development of type 2 diabetes. The primary outcome variable was the change in fasting plasma glucose (FPG) from study entry to one-year follow-up. At one-year follow-up, the intervention group showed significant improvements over the wait control group on stress, diet self-efficacy, and quality of life. There was no evidence of an effect of the intervention on measures of biochemistry or anthropometry; the effect on one health behaviour, diet adherence, was close to significance. Prevention programmes must tackle the barriers to participation faced by this population; home-based interventions should be investigated. Strategies for promoting long-term health self-management need to be developed and tested.

Competency-Based Training and Worker Turnover in Community Supports for People with IDD: Results from a Group Randomized Controlled Study

Science.gov (United States)

Bogenschutz, Matthew; Nord, Derek; Hewitt, Amy

2015-01-01

Turnover among direct support professionals (DSPs) in community support settings for individuals with intellectual and developmental disabilities (IDD) has been regarded as a challenge since tracking of this workforce began in the 1980s. This study utilized a group randomized controlled design to test the effects of a competency-based training…

Evaluation of the effect of Spiritual care on patients with generalized anxiety and depression: a randomized controlled study.

Science.gov (United States)

Sankhe, A; Dalal, K; Save, D; Sarve, P

2017-12-01

The present study was conducted to assess the effect of spiritual care in patients with depression, anxiety or both in a randomized controlled design. The participants were randomized either to receive spiritual care or not and Hamilton anxiety rating scale-A (HAM-A), Hamilton depression rating scale-D (HAM-D), WHO-quality of life-Brief (WHOQOL-BREF) and Functional assessment of chronic illness therapy - Spiritual well-being (FACIT-Sp) were assessed before therapy and two follow-ups at 3 and 6 week. However, with regard to the spiritual care therapy group, statistically significant differences were observed in both HAM-A and HAM-D scales between the baseline and visit 2 (p scales during the follow-up periods for the control group of participants. When the scores were compared between the study groups, HAM-A, HAM-D and FACIT-Sp 12 scores were significantly lower in the interventional group as compared to the control group at both third and sixth weeks. This suggests a significant improvement in symptoms of anxiety and depression in the spiritual care therapy group than the control group; however, large randomized controlled trials with robust design are needed to confirm the same.

Autoshaping, random control, and omission training in the rat1

Science.gov (United States)

Locurto, Charles; Terrace, H. S.; Gibbon, John

1976-01-01

The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping. PMID:16811960

The role of prophylactic internal iliac artery ligation in abnormally invasive placenta undergoing caesarean hysterectomy: a randomized control trial.

Science.gov (United States)

Hussein, Ahmed M; Dakhly, Dina Mohamed Refaat; Raslan, Ayman N; Kamel, Ahmed; Abdel Hafeez, Ali; Moussa, Manal; Hosny, Ahmed Samir; Momtaz, Mohamed

2018-04-25

To identify the role of bilateral internal iliac artery (IIA) ligation on reducing blood loss in abnormally invasive placenta (AIP) undergoing caesarean hysterectomy. In this parallel-randomized control trial, 57 pregnant females with ultrasound features suggestive of AIP were enrolled. They were randomized into two groups; IIA group (n = 29 cases) performed bilateral IIA ligation followed by caesarean hysterectomies, while Control group (n = 28 cases) underwent caesarean hysterectomy only. The main outcome was the difference in the estimated intraoperative blood loss between the two groups. There was no significant difference between the two groups regarding the intraoperative estimated blood loss (1632 ± 804 versus 1698 ± 1251, p value .83). The operative procedure duration (minutes) (223 ± 66 versus 171 ± 41.4, p value .001) varied significantly between the two groups. Bilateral internal iliac artery ligation, in cases of AIP undergoing caesarean hysterectomy, is not recommended for routine practice to minimize blood loss intraoperatively.

Aromatherapy for reducing colonoscopy related procedural anxiety and physiological parameters: a randomized controlled study.

Science.gov (United States)

Hu, Pei-Hsin; Peng, Yen-Chun; Lin, Yu-Ting; Chang, Chi-Sen; Ou, Ming-Chiu

2010-01-01

Colonoscopy is generally tolerated, some patients regarding the procedure as unpleasant and painful and generally performed with the patient sedated and receiving analgesics. The effect of sedation and analgesia for colonoscopy is limited. Aromatherapy is also applied to gastrointestinal endoscopy to reduce procedural anxiety. There is lack of information about aromatherapy specific for colonoscopy. In this study, we aimed to performed a randomized controlled study to investigate the effect of aromatherapy on relieve anxiety, stress and physiological parameters of colonoscopy. A randomized controlled trail was carried out and collected in 2009 and 2010. The participants were randomized in two groups. Aromatherapy was then carried out by inhalation of Sunflower oil (control group) and Neroli oil (Experimental group). The anxiety index was evaluated by State Trait Anxiety Inventory-state (STAI-S) score before aromatherapy and after colonoscopy as well as the pain index for post-procedural by visual analogue scale (VAS). Physiological indicators, such as blood pressure (systolic and diastolic blood pressure), heart rate and respiratory rate were evaluated before and after aromatherapy. Participates in this study were 27 subjects, 13 in control group and 14 in Neroli group with average age 52.26 +/- 17.79 years. There was no significance of procedural anxiety by STAI-S score and procedural pain by VAS. The physiological parameters showed a significant lower pre- and post-procedural systolic blood pressure in Neroli group than control group. Aromatic care for colonoscopy, although with no significant effect on procedural anxiety, is an inexpensive, effective and safe pre-procedural technique that could decrease systolic blood pressure.

An intervention to preschool children for reducing screen time: a randomized controlled trial.

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Yilmaz, G; Demirli Caylan, N; Karacan, C D

2015-05-01

Screen time, defined as time spent watching television, DVDs, or videos or playing computer or video games, has been related to serious health consequences in children, such as impaired language acquisition, violent behaviour, tobacco smoking and obesity. Our aim was to determine if a simple intervention aimed at preschool-aged children, applied at the health maintenance visits, in the primary care setting, would be effective in reducing screen time. We used a two group randomized controlled trial design. Two- to 6-year-old children and their parents were randomly assigned to receive an intervention to reduce their screen time, BMI and parental report of aggressive behaviour. At the end of the intervention we made home visits at 2, 6 and 9 months and the parents completed questionnaire. Parents in the intervention group reported less screen time and less aggressive behaviour than those in the control group but there were no differences in BMI z scores. This study shows that a preschool-based intervention can lead to reductions in young children's television/video viewing. © 2014 John Wiley & Sons Ltd.

Role of modified ultrfiltration in adult cardic surgery: a prospective randomized control trial

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Naveed, D.; Khan, R.A.; Malik, A.; Shah, S.Z.A.; Ullah, I.; Hussain, A.

2016-01-01

Background: Cardiopulmonary bypass (CPB) is associated with morbidity and mortality. To reduce its adverse effect modified ultrafiltration is being increasingly employed. This study is planned to evaluate the benefits of modified ultrafiltration (MUF) in adult cardiac surgery. Methods: Eighty consecutive patients presenting to adult cardiac surgery as elective case were enrolled. These patients were randomly divided in to two groups. MUF group which received modified ultrafiltration after separation from CPB and control group which did not receive modified ultrafiltration. Postoperative mediastinal and chest drainage in 24 hrs, blood products requirement, reopening, ICU stay, and mortality in 30 days were recorded. These variables were compared between MUF group and control group. Results: Forty patients were randomized to control group and 40 in MUF group. Mean age was 51.15±8.90 in control group as compared to 46.95±13.24 MUF group (p=0.1). Out of 40 patients in control group 7 (17.5 percentage) were female while 11 (27.5 percentage) out of total 40 were female in MUF group. (p=.284). Mean CBP time was 120.62±20.97 in control group versus 117.37±38.78 in MUF group (p=0.64). Post-operative drain output ranged from 330 ml to 1300 ml in control group and 300 ml to 780 ml in MUF group. Mean postoperative drain output 554.25±192.57 in control group versus 439.22±89.59 in MUF group (p=.001). Three (7.5 percentage) out of 40 patients required re-exploration in control group versus 1 (2.5 percentage) in MUF group. (p=.305). Mean ICU stay was 52.80±22.37 hours in control group versus 45.30±21.82 hours in MUF group (p=0.133). Three (7.5 percentage) out of 40 patients died in control group versus 1 (2.5 percentage) in MUF group. (p=0.305). Conclusion: Use of modified ultrafiltration is associated with low postoperative bleeding less requirements of blood and blood products. (author)

The Effectiveness of Group Cognitive Behavioral Therapy in Treating Obsessive-Compulsive Disorder in Women with Multiple Sclerosis (MS): A randomized double-blind controlled trial.

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Sayyah, Mehdi; Bagheri, Parisa; Karimi, Negar; Ghasemzadeh, Azizreza

2016-04-01

Obsessive-compulsive disorder (OCD) is one of the most prevalent psychiatric disorders and can cause problems for individuals in all aspects of life, including social and personal dimensions. To study the effect of group cognitive-behavioral therapy on the reduction of OCD symptoms in female participants with multiple sclerosis (MS). This double-blind randomized control trial was conducted from May 2012 to December 2014. The participants included 75 patients with MS who suffered from OCD and were referred to the Loghman Hakim and Imam Khomeini hospitals in Tehran, Iran. Thirty participants had been diagnosed through Yale-Brown Obsessive-Compulsive Symptoms (Y-BOCS). The participants were randomly divided into an experimental group (n=15) and a control group (n=15). Eleven sessions of cognitive-behavioral therapy were provided for the experimental group. Patients in the control group continued with their normal living. Hypotheses were tested using an analysis of covariance (ANCOVA). A significant reduction was found in the experimental group's obsessive-compulsive symptoms after cognitive-behavioral therapy (pcognitive-behavioral therapy could considerably reduce OCD symptoms in women with MS. The application of this method by therapists, especially Iranian clinicians, is recommended.

A randomized controlled trial of Tai chi for balance, sleep quality and cognitive performance in elderly Vietnamese

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Nguyen MH

2012-06-01

Full Text Available Manh Hung Nguyen, Andreas KruseInstitute of Gerontology, Heidelberg University, Heidelberg, GermanyObjective: To evaluate the effects of Tai chi exercise on balance, sleep quality, and cognitive performance in community-dwelling elderly in Vinh city, Vietnam.Design: A randomized controlled trial.Participants: One hundred two subjects were recruited.Intervention: Subjects were divided randomly into two groups. The Tai chi group was assigned 6 months' Tai chi training. The control group was instructed to maintain their routine daily activities.Outcome measures: The Falls Efficacy Scale (FES, Pittsburgh Sleep Quality Index (PSQI, and Trail Making Test (TMT were used as primary outcome measures.Results: Participants in the Tai chi group reported significant improvement in TMT (part A (F [1, 71] = 78.37, P < 0.001 and in TMT (part B, (F [1, 71] = 175.00, P < 0.001 in comparison with the control group. Tai chi participants also reported better scores in FES (F [1, 71] = 96.90, P < 0.001 and in PSQI (F [1,71] = 43.69, P = 0.001 than the control group.Conclusion: Tai chi is beneficial to improve balance, sleep quality, and cognitive performance of the elderly.Keywords: Tai chi, sleep, balance 

A randomized controlled trial of a multifaceted integrated complementary-alternative therapy for chronic herpes zoster-related pain.

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Hui, Fred; Boyle, Eleanor; Vayda, Eugene; Glazier, Richard H

2012-03-01

Our objective was to determine whether a three-week complementary and alternative medicine (CAM) approach integrating several therapies from Traditional Chinese Medicine (TCM) along with neural therapy (injection of 1% procaine as local anesthesia) reduces the level of unresolved pain associated with herpes zoster. The design was a randomized controlled clinical trial in a community-based primary care clinic in Toronto, Ontario. We studied individuals 18 years of age and older with a confirmed diagnosis of herpes zoster of at least 30 days duration and with at least moderate postherpetic neuralgia pain (≥4) on a 10-point Likert scale. The CAM therapies used were acupuncture, neural therapy (1% procaine injection as a local anesthetic), cupping and bleeding, and TCM herbs. An immediate treatment group (n=32) received the CAM intervention once daily, five days per week, for three weeks. A wait-list (delayed treatment) group (n=27) was used as a control and received the same treatment starting three weeks after randomization. This three-week time period, when one group was receiving active CAM treatment and the other was not, was used as basis of comparison for treatment effects between groups. Pain, quality of life, and depression were measured at baseline, and three, six, and nine weeks post-randomization. Patients were followed for up to two years. Participants had a mean age of 69.8 years (SD=11.1) and had had herpes zoster-related pain for a median of 4.8 months (range: 1 month to 15 years). The immediate treatment and control groups had similar pain levels at baseline (treatment = 7.5; control = 7.8; p=0.5; scores based on the 10-point Likert pain scale). At three weeks post-randomization (i.e., after the immediate treatment group completed treatment) pain scores differed significantly (treatment = 2.3; control = 7.2; ppain in the immediate treatment group was maintained at nine weeks and at long-term follow-up (one to two years later). The delayed treatment

School-based mindfulness intervention for stress reduction in adolescents: Design and methodology of an open-label, parallel group, randomized controlled trial

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Jeanette M. Johnstone

2016-12-01

Full Text Available Adolescents are in a high-risk period developmentally, in terms of susceptibility to stress. A mindfulness intervention represents a potentially useful strategy for developing cognitive and emotion regulation skills associated with successful stress coping. Mindfulness strategies have been used successfully for emotional coping in adults, but are not as well studied in youth. This article details a novel proposal for the design of an 8-week randomized study to evaluate a high school-based mindfulness curriculum delivered as part of a two semester health class. A wellness education intervention is proposed as an active control, along with a waitlist control condition. All students enrolled in a sophomore (10th grade health class at a private suburban high school will be invited to participate (n = 300. Pre-test assessments will be obtained by youth report, parent ratings, and on-site behavioral testing. The assessments will evaluate baseline stress, mood, emotional coping, controlled attention, and working memory. Participants, divided into 13 classrooms, will be randomized into one of three conditions, by classroom: A mindfulness intervention, an active control (wellness education, and a passive control (waitlist. Waitlisted participants will receive one of the interventions in the following term. Intervention groups will meet weekly for 8 weeks during regularly scheduled health classes. Immediate post-tests will be conducted, followed by a 60-day post-test. It is hypothesized that the mindfulness intervention will outperform the other conditions with regard to the adolescents' mood, attention and response to stress.

Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol

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Kim Yong-Suk

2011-03-01

Full Text Available Abstract Objective Incomplete recovery from facial palsy has a long-term impact on the quality of life, and medical options for the sequelae of Bell's palsy are limited. Invasive treatments and physiotherapy have been employed to relieve symptoms, but there is limited clinical evidence for their effectiveness. Acupuncture is widely used on Bell's palsy patients in East Asia, but there is insufficient evidence for its effectiveness on Bell's palsy sequelae. The objective is to evaluate the efficacy and safety of acupuncture in patients with sequelae of Bell's palsy. Method/Design This study consists of a randomized controlled trial with two parallel arms: an acupuncture group and a waitlist group. The acupuncture group will receive acupuncture treatment three times per week for a total of 24 sessions over 8 weeks. Participants in the waitlist group will not receive any acupuncture treatments during this 8 week period, but they will participate in the evaluations of symptoms at the start of the study, at 5 weeks and at 8 weeks after randomization, at which point the same treatment as the acupuncture group will be provided. The primary outcome will be analyzed by the change in the Facial Disability Index (FDI from baseline to week eight. The secondary outcome measures will include FDI from baseline to week five, House-Brackmann Grade, lip mobility, and stiffness scales. Trial registration Current Controlled-Trials ISRCTN43104115; registration date: 06 July 2010; the date of the first patient's randomization: 04 August 2010

Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol

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2011-01-01

Objective Incomplete recovery from facial palsy has a long-term impact on the quality of life, and medical options for the sequelae of Bell's palsy are limited. Invasive treatments and physiotherapy have been employed to relieve symptoms, but there is limited clinical evidence for their effectiveness. Acupuncture is widely used on Bell's palsy patients in East Asia, but there is insufficient evidence for its effectiveness on Bell's palsy sequelae. The objective is to evaluate the efficacy and safety of acupuncture in patients with sequelae of Bell's palsy. Method/Design This study consists of a randomized controlled trial with two parallel arms: an acupuncture group and a waitlist group. The acupuncture group will receive acupuncture treatment three times per week for a total of 24 sessions over 8 weeks. Participants in the waitlist group will not receive any acupuncture treatments during this 8 week period, but they will participate in the evaluations of symptoms at the start of the study, at 5 weeks and at 8 weeks after randomization, at which point the same treatment as the acupuncture group will be provided. The primary outcome will be analyzed by the change in the Facial Disability Index (FDI) from baseline to week eight. The secondary outcome measures will include FDI from baseline to week five, House-Brackmann Grade, lip mobility, and stiffness scales. Trial registration Current Controlled-Trials ISRCTN43104115; registration date: 06 July 2010; the date of the first patient's randomization: 04 August 2010 PMID:21388554

Efficacy of two antiseptic regimens on skin colonization of insertion sites for two different catheter types: a randomized, clinical trial.

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Lutz, Juergen Thomas; Diener, Isabel Victoria; Freiberg, Kerstin; Zillmann, Robert; Shah-Hosseini, Kija; Seifert, Harald; Berger-Schreck, Bettina; Wisplinghoff, Hilmar

2016-12-01

Catheter-related bloodstream infections affect patients in surgical and intensive care settings worldwide, causing complications, aggravation of existing symptoms and increased length of stay. The trial aimed at comparing two registered skin antiseptics with respect to their residual and therefore infection-preventing effects. In a parallel, monocentric, prospective, triple-blind, randomized trial the difference in bacterial recolonization of catheter skin sites in central venous (CVC) and epidural catheters (EC) was investigated by comparing two alcoholic-based skin disinfectants. Patients receiving planned surgeries or intensive care were eligible for the trial. Those in the trial group received skin disinfection with the additive octenidine dihydrochloride (OCT) (n = 51), those in the control group were treated with benzalkonium chloride as additive (BAC) (n = 59) prior to catheter insertion. Randomization was carried out by assigning patients to groups week-wise. Endpoints of the investigation were skin colonization of the catheter site counted in colony forming units per swab at three time points: (1) prior to catheter insertion, on untreated skin; (2) directly after catheter insertion, prior to sterile coverage; (3) 48 h after catheter insertion. The hypothesis was tested by a Wilcoxon test with a two-sided alpha = 5 %. From second to third swab, recolonization of the catheter-surrounding skin was significantly lower in the trial group for both sorts of catheters: delta 2-3 OCT group: 0.72 (95 % CI: 0.42; 1.02); delta 2-3 BAC group: 1.97 (95 % CI: 1.45; 2.50); p < 0.001. None of the patients enrolled developed a catheter-related blood stream infection (CRBSI) during follow-up. Previous studies have shown that skin colonization is strongly associated with the occurrence of CRBSI. This randomized controlled trial supports the observations made in previous trials that octenidine dihydrochloride in disinfectants is more effective than agents

The efficacy of imagery rescripting (IR) for social phobia: a randomized controlled trial.

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Lee, Seung Won; Kwon, Jung-Hye

2013-12-01

There is a need for brief effective treatment of social phobia and Imagery Rescripting (IR) is a potential candidate. The purpose of this study was to examine the efficacy of IR preceded by cognitive restructuring as a stand-alone brief treatment using a randomized controlled design. Twenty-three individuals with social phobia were randomly assigned to an IR group or to a control group. Participants in the IR group were provided with one session of imagery interviewing and two sessions of cognitive restructuring and Imagery Rescripting. Those in the control group had one session of clinical interviewing and two sessions of supportive therapy. Outcome measures including the Korean version of the social avoidance and distress scale (K-SADS) were administered before and after treatment, and at three-month follow-up. The short version of the Questionnaire upon Mental Imagery and the Traumatic Experience Scale were also administered before treatment. Participants in the IR group improved significantly on K-SADS and other outcome measures, compared to the control group. The beneficial effects of IR were maintained at three-month follow-up. It was also found that mental imagery ability and the severity of the traumatic experience did not moderate the outcome of IR. Further studies are needed to replicate the findings of our study using a large sample. The efficacy of IR as a stand-alone brief treatment was demonstrated for social phobia. The findings indicate that IR could be utilized as a cost-effective intervention for social phobia. Copyright © 2013 Elsevier Ltd. All rights reserved.

Effects of prenatal yoga on women's stress and immune function across pregnancy: A randomized controlled trial.

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Chen, Pao-Ju; Yang, Luke; Chou, Cheng-Chen; Li, Chia-Chi; Chang, Yu-Cune; Liaw, Jen-Jiuan

2017-04-01

The effects of prenatal yoga on biological indicators have not been widely studied. Thus, we compared changes in stress and immunity salivary biomarkers from 16 to 36 weeks' gestation between women receiving prenatal yoga and those receiving routine prenatal care. For this longitudinal, prospective, randomized controlled trial, we recruited 94 healthy pregnant women at 16 weeks' gestation through convenience sampling from a prenatal clinic in Taipei. Participants were randomly assigned to intervention (n=48) or control (n=46) groups using Clinstat block randomization. The 20-week intervention comprised two weekly 70-min yoga sessions led by a midwife certified as a yoga instructor; the control group received only routine prenatal care. In both groups, participants' salivary cortisol and immunoglobulin A levels were collected before and after yoga every 4 weeks from 16 to 36 weeks' gestation. The intervention group had lower salivary cortisol (pcontrol group. Specifically, the intervention group had significantly higher long-term salivary immunoglobulin A levels than the control group (p=0.018), and infants born to women in the intervention group weighed more than those born to the control group (pPrenatal yoga significantly reduced pregnant women's stress and enhanced their immune function. Clinicians should learn the mechanisms of yoga and its effects on pregnant women. Our findings can guide clinicians to help pregnant women alleviate their stress and enhance their immune function. Copyright © 2017. Published by Elsevier Ltd.

The role of adding metformin in insulin-resistant diabetic pregnant women: a randomized controlled trial.

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Ibrahim, Moustafa Ibrahim; Hamdy, Ahmed; Shafik, Adel; Taha, Salah; Anwar, Mohammed; Faris, Mohammed

2014-05-01

The aim of the present study is to assess the impact of adding oral metformin to insulin therapy in pregnant women with insulin-resistant diabetes mellitus. The current non-inferiority randomized controlled trial was conducted at Ain Shams University Maternity Hospital. The study included pregnant women with gestational or pre-existing diabetes mellitus at gestations between 20 and 34 weeks, who showed insulin resistance (defined as poor glycemic control at a daily dose of ≥1.12 units/kg). Recruited women were randomized into one of two groups: group I, including women who received oral metformin without increasing the insulin dose; and group II, including women who had their insulin dose increased. The primary outcome was maternal glycemic control. Secondary outcomes included maternal bouts of hypoglycemia, need for another hospital admission for uncontrolled diabetes during pregnancy, gestational age at delivery, mode of delivery, birth weight, birth trauma, congenital anomalies, 1- and 5-min Apgar score, neonatal hypoglycemia, need for neonatal intensive care unit (NICU) admission and adverse neonatal outcomes. A total number of 154 women with diabetes mellitus with pregnancy were approached; of them 90 women were eligible and were randomly allocated and included in the final analysis. The recruited 90 women were randomized into one of two groups: group I (metformin group) (n = 46), including women who received oral metformin in addition to the same initial insulin dose; and group II (control group) (n = 44), including women who had their insulin dose increased according to the standard protocol. The mean age of included women was 29.84 ± 5.37 years (range 20-42 years). The mean gestational age at recruitment was 28.7 ± 3.71 weeks (range 21-34 weeks). Among the 46 women of group I, 17 (36.9 %) women reached proper glycemic control at a daily metformin dose of 1,500 mg, 18 (39.2 %) at a daily dose of 2,000 mg, while 11 (23.9 %) received metformin at a daily

Long-term follow-up of a randomized study of support group intervention in women with primary breast cancer.

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Björneklett, Helena Granstam; Rosenblad, Andreas; Lindemalm, Christina; Ojutkangas, Marja-Leena; Letocha, Henry; Strang, Peter; Bergkvist, Leif

2013-04-01

Despite a fairly good prognosis, many breast-cancer patients suffer from symptoms such as anxiety, depression and fatigue, which may affect health-related quality of life and may persist for several years. The aim of the present study was to perform a long-term follow-up of a randomized study of support group intervention in women after primary breast cancer treatment. Three hundred and eighty two women with primary breast cancer were randomized to support group intervention or control group, 181 in each group. Women in the intervention group participated in 1 week of intervention followed by 4 days of follow-up 2 months later. This is a long-term follow-up undertaken, in average, 6.5 years after randomization. Patients answered the questionnaires the European Organisation for Research and Treatment of Cancer, quality of life questionnaire (EORTC QLQ-C30) and the breast cancer module questionnaire (BR 23), the hospital anxiety and depression scale (HAD) and the Norwegian version of the fatigue scale (FQ). After adjusting for treatment with chemotherapy, age, marriage, education and children at home, there was a significant improvement in physical, mental and total fatigue (FQ), cognitive function, body image and future perspective (EORTC QLQ C30 and BR23) in the intervention group compared with controls. The proportion of women affected by high anxiety and depression scores were not significantly different between the groups. Support intervention significantly improved cognitive function, body image, future perspective and fatigue, compared with to the findings in the control group. Copyright © 2012 Elsevier Inc. All rights reserved.

The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study – a randomized controlled trial

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Smith Lisa

2008-11-01

Full Text Available Abstract Background Few studies have investigated the specific effect of single intervention components in randomized controlled trials. The purpose was to investigate the effect of adding group-based diet and exercise counselling to individual life-style counselling on long-term changes in dietary habits. Methods The study was a randomized controlled intervention study. From a general Danish population, aged 30 to 60 years (n = 61,301, two random sample were drawn (group A, n = 11,708; group B, n = 1,308. Subjects were invited for a health screening program. Participation rate was 52.5%. All participants received individual life-style counselling. Individuals at high risk of ischemic heart disease in group A were furthermore offered group-based life-style counselling. The intervention was repeated for high-risk individuals after one and three years. At five-year follow-up all participants were invited for a health examination. High risk individuals were included in this study (n = 2 356 and changes in dietary intake were analyzed using multilevel linear regression analyses. Results At one-year follow-up group A had significantly increased the unsaturated/saturated fat ratio compared to group B and in men a significantly greater decrease in saturated fat intake was found in group A compared to group B (net change: -1.13 E%; P = 0.003. No differences were found between group A and B at three-year follow-up. At five-year follow-up group A had significantly increased the unsaturated/saturated fat ratio (net change: 0.09; P = 0.01 and the fish intake compared to group B (net change: 5.4 g/day; P = 0.05. Further, in men a non-significant tendency of a greater decrease was found at five year follow-up in group A compared to group B (net change: -0.68 E%; P = 0.10. The intake of fibre and vegetables increased in both groups, however, no significant difference was found between the groups. No differences between groups were found for saturated fat

Web-based screening and brief intervention for poly-drug use among teenagers: study protocol of a multicentre two-arm randomized controlled trial.

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Arnaud, Nicolas; Bröning, Sonja; Drechsel, Magdalena; Thomasius, Rainer; Baldus, Christiane

2012-09-26

Mid to late adolescence is characterised by a vulnerability to problematic substance use since the consumption of alcohol and illicit drugs is frequently initiated and increased in this life period. While the detrimental long- and short-term effects of problematic consumption patterns in adolescence pose a major public health concern, current prevention programs targeting alcohol- and other substance-using adolescents are scarce. The study described in this protocol will test the effectiveness of a web-based brief intervention aimed at reducing problematic alcohol use and promoting abstinence from illegal drugs in adolescents with risky substance use aged 16 to 18 years old in four EU-countries. To determine the effectiveness of our web-BI, we apply a two-arm randomized controlled trial (RCT) study design, with baseline assessment at study entry and a three month follow-up assessment. Adolescents aged 16 to 18 years from Belgium, the Czech Republic, Germany, and Sweden will be randomly assigned to either the fully electronically delivered brief intervention group (N = 400) or an assessment only control group (N = 400) depending on their screening for risky substance use (using the CRAFFT). Recruitment, informed consent, randomization, intervention and follow-up will be implemented online. Primary outcomes are reductions in frequency and quantity of use of alcohol and drugs other than alcohol over a 30 day period, as well as consumption per typical occasion. Secondary outcomes concern changes in substance use related cognitions including the constructs of the Theory of Planned Behaviour, implementation intentions, and stages of change. Moreover the study addresses a number of moderator variables, including age of first use, general psychopathology and quality of parent-child relationship. The trial is expected to contribute to the growing literature on theory- and web-based brief interventions for adolescents. We will explore the potential of using web

A randomized controlled trial of a manual-based psychosocial group intervention for young people with epilepsy [PIE].

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Dorris, Liam; Broome, Helen; Wilson, Margaret; Grant, Cathy; Young, David; Baker, Gus; Balloo, Selina; Bruce, Susan; Campbell, Jo; Concannon, Bernie; Conway, Nadia; Cook, Lisa; Davis, Cheryl; Downey, Bruce; Evans, Jon; Flower, Diane; Garlovsky, Jack; Kearney, Shauna; Lewis, Susan; Stephens, Victoria; Turton, Stuart; Wright, Ingram

2017-07-01

We conducted an exploratory RCT to examine feasibility and preliminary efficacy for a manual-based psychosocial group intervention aimed at improving epilepsy knowledge, self-management skills, and quality of life in young people with epilepsy. Eighty-three participants (33:50m/f; age range 12-17years) were randomized to either the treatment or control group in seven tertiary paediatric neuroscience centres in the UK, using a wait-list control design. Participants were excluded if they reported suicidal ideation and/or scored above the cut off on mental health screening measures, or if they had a learning disability or other neurological disorder. The intervention consisted of six weekly 2-hour sessions using guided discussion, group exercises and role-plays facilitated by an epilepsy nurse and a clinical psychologist. At three month follow up the treatment group (n=40) was compared with a wait-list control group (n=43) on a range of standardized measures. There was a significant increase in epilepsy knowledge in the treatment group (p=0.02). Participants receiving the intervention were also significantly more confident in speaking to others about their epilepsy (p=0.04). Quality of life measures did not show significant change. Participants reported the greatest value of attending the group was: Learning about their epilepsy (46%); Learning to cope with difficult feelings (29%); and Meeting others with epilepsy (22%). Caregiver and facilitator feedback was positive, and 92% of participants would recommend the group to others. This brief psychosocial group intervention was effective in increasing participants' knowledge of epilepsy and improved confidence in discussing their epilepsy with others. We discuss the qualitative feedback, feasibility, strengths and limitations of the PIE trial. Copyright © 2017 Elsevier Inc. All rights reserved.

Infant-mother attachment can be improved through group intervention: a preliminary evaluation in Spain in a non-randomized controlled trial.

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Torres, Bárbara; Alonso-Arbiol, Itziar; Cantero, María José; Abubakar, Amina

2011-11-01

The quality of infant-mother attachment has been linked to competence in different domains of child development. Research indicates that early intervention can enhance the quality of infant-mother attachment, though its efficacy in a group format has yet to be evaluated. The current study is aimed at examining the usefulness of a group intervention in enhancing infant-mother attachment. An intervention aimed at addressing aspects such as maternal responsivity, sensitivity and childrearing behaviour was developed by the researchers and experienced psychologists. The intervention spanned a period of 14 months starting from the third quarter of pregnancy. The intervention was evaluated among 24 mothers from the Basque region of Spain. The sample consisted of children of both genders in a similar proportion: 45.8% were boys and 54.2% were girls. The children in this sample were full-term born and did not present symptoms of any serious pre- or postnatal complications. The intervention had a statistically non-significant medium effect. Infants whose mothers had received the intervention showed higher rates of secure attachment compared to children from the control group, as assessed by the Strange Situation observation procedure. A potentially significant confounding variable, maternal attachment, was balanced across the intervention and comparison groups. We can tentatively point out that a group intervention may enhance the quality of infant-mother attachment. Nevertheless, because the study design was not randomized, the results of this study remain preliminary and need replication in a full randomized controlled trial designed study.

Yoga for generalized anxiety disorder: design of a randomized controlled clinical trial.

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Hofmann, Stefan G; Curtiss, Joshua; Khalsa, Sat Bir S; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

2015-09-01

Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to be the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N=95) to both CBT for GAD (N=95) and stress education (N=40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications. Copyright © 2015 Elsevier Inc. All rights reserved.

Effect of Yoga Based Lifestyle Intervention on Patients With Knee Osteoarthritis: A Randomized Controlled Trial

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Deepeshwar, Singh; Tanwar, Monika; Kavuri, Vijaya; Budhi, Rana B.

2018-01-01

Objective: To investigate the effect of integrated approach of yoga therapy (IAYT) intervention in individual with knee Osteoarthritis. Design: Randomized controlled clincial trail. Participants: Sixty-six individual prediagnosed with knee osteoarthritis aged between 30 and 75 years were randomized into two groups, i.e., Yoga (n = 31) and Control (n = 35). Yoga group received IAYT intervention for 1 week at yoga center of S-VYASA whereas Control group maintained their normal lifestyle. Outcome measures: The Falls Efficacy Scale (FES), Handgrip Strength test (left hand LHGS and right hand RHGS), Timed Up and Go Test (TUG), Sit-to-Stand (STS), and right & left extension and flexion were measured on day 1 and day 7. Results: There were a significant reduction in TUG (p Yoga group. Conclusion: IAYT practice showed an improvement in TUG, STS, HGS, and Goniometer test, which suggest improved muscular strength, flexibility, and functional mobility. CTRI Registration Number: http://ctri.nic.in/Clinicaltrials, identifier CTRI/2017/10/010141. PMID:29867604

Can a pilates exercise program be effective on balance, flexibility and muscle endurance? A randomized controlled trial.

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Kibar, Sibel; Yardimci, Fatma Ö; Evcik, Deniz; Ay, Saime; Alhan, Aslıhan; Manço, Miray; Ergin, Emine S

2016-10-01

This randomized controlled study aims to determine the effect of pilates mat exercises on dynamic and static balance, hamstring flexibility, abdominal muscle activity and endurance in healthy adults. Female healthy volunteer university students randomly assigned into two groups. Group 1 followed a pilates program for an hour two times a week. Group 2 continued daily activities as control group. Dynamic and static balance were evaluated by Sport Kinesthetic Ability Trainer (KAT) 4000 device. Hamstring flexibility and abdominal endurance were determined by sit-and-reach test, curl-up test respectively. Pressure biofeedback unit (PBU) was used to measure transversus abdominis and lumbar muscle activity. The physical activity of the participants was followed by International Physical Activity Questionnaire-Short Form. Twenty-three subjects in pilates group and 24 control subjects completed the study. In pilates group, statistical significant improvements were observed in curl-up, sit-and-reach test, PBU scores at sixth week (Ppilates group for sit-and-reach test (P=0.01) and PBU scores (Ppilates training program has been found to have beneficial effect on static balance, flexibility, abdominal muscle endurance, abdominal and lumbar muscle activity. These parameters have no effect on balance.

Independent and Social Living Skills Training for People with Schizophrenia in Iran: a Randomized Controlled Trial

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Ashraf Karbalaee-Nouri

2015-09-01

Full Text Available Objectives: Schizophrenia is responsible for a significant proportion of burden of mental diseases in Iran. Lack of a follow-up system has resulted in the repeated hospitalizations. In this study it is hypothesized that standardized living skills training delivered to participants with schizophrenia in outpatient and inpatient centers can be effective compared to a  control group (with occupational therapy in reducing psychopathology severity and increasing quality of life. Methods: This is a multi-centered parallel group randomized controlled trial in Iran and it is single-blinded. Eligible participants are randomly allocated into two groups in a 1:1 ratio. Participants are assigned by stratified balanced block randomization method. The trial is conducted in the cities of Tehran and Mashhad. Its aim is to recruit 160 clients with schizophrenia. The intervention for the experimental group is social living skills training. The intervention for the control group is occupational therapy. The intervention for both groups is conducted in 90 to 120-minute group sessions. Results: The primary outcome of the study would be a decrease in  psychopathology severity, an improvement in participants' quality of life, and reduction in family burden will be followed for 6 months. Discussion: This paper presents a protocol for a randomized controlled trial of independent and social living skills training intervention delivered to participants with schizophrenia. If this intervention is effective, it could be scaled up to be developing for policymaking and improving outcomes for schizophrenic participants and their families in Iran.

Effects of two exercise protocols on postural balance of elderly women: a randomized controlled trial

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Mesquita, Laiana Sep?lveda de Andrade; de Carvalho, Fabiana Texeira; Freire, Lara Sep?lveda de Andrade; Neto, Osmar Pinto; Z?ngaro, Renato Amaro

2015-01-01

Background The aging process reduces both sensory capabilities and the capabilities of the motor systems responsible for postural control, resulting in a high number of falls among the elderly. Some therapeutic interventions can directly interrupt this process, including physical exercise. This study compares and examines the effects of two exercise protocols on the balance of elderly women. Methods Elderly women who participated in a local church project (n?=?63) were randomly divided into t...

Self-Administered Computer Therapy for Apraxia of Speech: Two-Period Randomized Control Trial With Crossover.

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Varley, Rosemary; Cowell, Patricia E; Dyson, Lucy; Inglis, Lesley; Roper, Abigail; Whiteside, Sandra P

2016-03-01

There is currently little evidence on effective interventions for poststroke apraxia of speech. We report outcomes of a trial of self-administered computer therapy for apraxia of speech. Effects of speech intervention on naming and repetition of treated and untreated words were compared with those of a visuospatial sham program. The study used a parallel-group, 2-period, crossover design, with participants receiving 2 interventions. Fifty participants with chronic and stable apraxia of speech were randomly allocated to 1 of 2 order conditions: speech-first condition versus sham-first condition. Period 1 design was equivalent to a randomized controlled trial. We report results for this period and profile the effect of the period 2 crossover. Period 1 results revealed significant improvement in naming and repetition only in the speech-first group. The sham-first group displayed improvement in speech production after speech intervention in period 2. Significant improvement of treated words was found in both naming and repetition, with little generalization to structurally similar and dissimilar untreated words. Speech gains were largely maintained after withdrawal of intervention. There was a significant relationship between treatment dose and response. However, average self-administered dose was modest for both groups. Future software design would benefit from incorporation of social and gaming components to boost motivation. Single-word production can be improved in chronic apraxia of speech with behavioral intervention. Self-administered computerized therapy is a promising method for delivering high-intensity speech/language rehabilitation. URL: http://orcid.org/0000-0002-1278-0601. Unique identifier: ISRCTN88245643. © 2016 American Heart Association, Inc.

Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group.

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Pradhan, Menno; Brinkman, Sally A; Beatty, Amanda; Maika, Amelia; Satriawan, Elan; de Ree, Joppe; Hasan, Amer

2013-08-16

This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program was developed in collaboration with the World Bank with a total budget of US$127.7 million, and targets an estimated 738,000 children aged 0 to 6 years living in approximately 6,000 poor communities. The aim of the program is to increase access to early childhood services with the secondary aim of improving school readiness. The study is being conducted across nine districts. The baseline survey contained 310 villages, of which 100 were originally allocated to the intervention arm, 20 originally allocated to a 9-month delay staggered start, 100 originally allocated to an 18-month delay staggered start and 90 allocated to a matched control group (no intervention). The study consists of two cohorts, one comprising children aged 12 to 23 months and the other comprising children aged 48 to 59 months at baseline. The data collection instruments include child observations and task/game-based assessments as well as a questionnaire suite, village head questionnaire, service level questionnaires, household questionnaire, and child caretaker questionnaire. The baseline survey was conducted from March to April 2009, midline was conducted from April to August 2010 and endline conducted early 2013. The resultant participation rates at both the district and village levels were 90%. At the child level, the participation rate was 99.92%. The retention rate at the child level at midline was 99.67%. This protocol paper provides a detailed record of the trial design including a discussion regarding difficulties faced with compliance to the randomization, compliance to the dispersion schedule of community block grants, and procurement delays for baseline and midline data collections. Considering the

Comparison of two control groups for estimation of oral cholera vaccine effectiveness using a case-control study design.

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Franke, Molly F; Jerome, J Gregory; Matias, Wilfredo R; Ternier, Ralph; Hilaire, Isabelle J; Harris, Jason B; Ivers, Louise C

2017-10-13

Case-control studies to quantify oral cholera vaccine effectiveness (VE) often rely on neighbors without diarrhea as community controls. Test-negative controls can be easily recruited and may minimize bias due to differential health-seeking behavior and recall. We compared VE estimates derived from community and test-negative controls and conducted bias-indicator analyses to assess potential bias with community controls. From October 2012 through November 2016, patients with acute watery diarrhea were recruited from cholera treatment centers in rural Haiti. Cholera cases had a positive stool culture. Non-cholera diarrhea cases (test-negative controls and non-cholera diarrhea cases for bias-indicator analyses) had a negative culture and rapid test. Up to four community controls were matched to diarrhea cases by age group, time, and neighborhood. Primary analyses included 181 cholera cases, 157 non-cholera diarrhea cases, 716 VE community controls and 625 bias-indicator community controls. VE for self-reported vaccination with two doses was consistent across the two control groups, with statistically significant VE estimates ranging from 72 to 74%. Sensitivity analyses revealed similar, though somewhat attenuated estimates for self-reported two dose VE. Bias-indicator estimates were consistently less than one, with VE estimates ranging from 19 to 43%, some of which were statistically significant. OCV estimates from case-control analyses using community and test-negative controls were similar. While bias-indicator analyses suggested possible over-estimation of VE estimates using community controls, test-negative analyses suggested this bias, if present, was minimal. Test-negative controls can be a valid low-cost and time-efficient alternative to community controls for OCV effectiveness estimation and may be especially relevant in emergency situations. Copyright © 2017. Published by Elsevier Ltd.

High School Students with Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention

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Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G.; Fall, Anna-Mária; Schnakenberg, Jennifer B.

2015-01-01

A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state…

Randomized controlled trial of a patient decision-making aid for orthodontics.

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Parker, Kate; Cunningham, Susan J; Petrie, Aviva; Ryan, Fiona S

2017-08-01

Patient decision-making aids (PDAs) are instruments that facilitate shared decision making and enable patients to reach informed, individual decisions regarding health care. The objective of this study was to assess the efficacy of a PDA compared with traditional information provision for adolescent patients considering fixed appliance orthodontic treatment. Before treatment, orthodontic patients were randomly allocated into 2 groups: the intervention group received the PDA and standard information regarding fixed appliances, and the control group received the standard information only. Decisional conflict was measured using the Decisional Conflict Scale, and the levels of decisional conflict were compared between the 2 groups. Seventy-two patients were recruited and randomized in a ratio of 1:1 to the PDA and control groups. Seventy-one patients completed the trial (control group, 36; PDA group, 35); this satisfied the sample size calculation. The median total Decisional Conflict Scale score in the PDA group was lower than in the control group (15.63 and 19.53, respectively). However, this difference was not statistically significant (difference between groups, 3.90; 95% confidence interval of the difference, -4.30 to 12.11). Sex, ethnicity, age, and the time point at which patients were recruited did not have significant effects on Decisional Conflict Scale scores. No harm was observed or reported for any participant in the study. The results of this study showed that the provision of a PDA to adolescents before they consented for fixed appliances did not significantly reduce decisional conflict. There may be a benefit in providing a PDA for some patients, but it is not yet possible to say how these patients could be identified. This trial was registered with the Harrow National Research Ethics Committee (reference 12/LO/0279). The protocol was not published before trial commencement. Copyright © 2017. Published by Elsevier Inc.

Immediate effect of nonspecific mandibular mobilization on postural control in subjects with temporomandibular disorder: a single-blind, randomized, controlled clinical trial.

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Amaral, Ana P; Politti, Fabiano; Hage, Yasmin E; Arruda, Eric E C; Amorin, Cesar F; Biasotto-Gonzalez, Daniela A

2013-01-01

Temporomandibular disorder (TMD) is considered multifactorial and is defined as a group of pain conditions characterized by functional stomatognathic system alterations, which may be affected by or related disrupted postural control. Assess the immediate effect of nonspecific mandibular mobilization (NMM) on the postural control of subjects diagnosed or not with TMD. A simple-blind, randomized, controlled clinical trial was performed involving 50 subjects of both genders assigned to two groups: the TMD group and the control group. TMD was diagnosed according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). A stabilometric assessment was performed by testing subjects in a quiet stance on a dual force platform under two visual conditions (eyes open and eyes closed). The Center of Pressure (CoP)-related variables analyzed were displacement, amplitude, speed of anterior-posterior (AP) and medial-lateral (ML) displacements and CoP sway area. The mean values of each variable were compared, considering the accepted significance value of ppostural control in patients with TMD.

Can the Onset of Type 2 Diabetes Be Delayed by a Group-Based Lifestyle Intervention in Women with Prediabetes following Gestational Diabetes Mellitus (GDM? Findings from a Randomized Control Mixed Methods Trial

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Angela O’Dea

2015-01-01

Full Text Available Objective. To evaluate a 12-week group-based lifestyle intervention programme for women with prediabetes following gestational diabetes (GDM. Design. A two-group, mixed methods randomized controlled trial in which 50 women with a history of GDM and abnormal glucose tolerance postpartum were randomly assigned to intervention (n=24 or wait control (n=26 and postintervention qualitative interviews with participants. Main Outcome Measures. Modifiable biochemical, anthropometric, behavioural, and psychosocial risk factors associated with the development of type 2 diabetes. The primary outcome variable was the change in fasting plasma glucose (FPG from study entry to one-year follow-up. Results. At one-year follow-up, the intervention group showed significant improvements over the wait control group on stress, diet self-efficacy, and quality of life. There was no evidence of an effect of the intervention on measures of biochemistry or anthropometry; the effect on one health behaviour, diet adherence, was close to significance. Conclusions. Prevention programmes must tackle the barriers to participation faced by this population; home-based interventions should be investigated. Strategies for promoting long-term health self-management need to be developed and tested.

Effects of two different feeding positions on physiological characteristics and feeding performance of preterm infants: A randomized controlled trial.

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Girgin, Burcu Aykanat; Gözen, Duygu; Karatekin, Güner

2018-04-01

The aim of this randomized controlled study was to determine the effect of semielevated side-lying (ESL) and semielevated supine (ESU) positions, which are used to bottle-feed preterm infants, on their physiological characteristics and feeding performance. The sample consisted of preterm infants who were born in the 31st gestational week and below, and met the inclusion criteria. A randomization was provided in the sample group with a total of 80 infants including 38 infants in the ESL (experimental) group and 42 infants in the ESU (control) group. Both groups were compared in terms of their SpO2 values, heart rates, and feeding performances before, during, and after the feeding. The data were obtained by using a form for infant descriptive characteristics, feeding follow-up form, a Masimo Radical-7 pulse oximeter device, and a video camera. It was determined that the infants in the ESL group had statistically significantly higher SpO2 values (ESL: 96.77 ± 2.51; ESU: 93.48 ± 5.63) and lower heart rates (ESL: 155.87 ± 11.18; ESU: 164.35 ± 6.00) during the feeding compared to the infants in the ESU group (p ESL group. The ESL position has a more positive effect on oxygen saturation and heart rate of infants and it is more effective in providing a physiological stabilization during the feeding, compared to the ESU position. According to these results, the ESL position can be recommended for preterm feeding. © 2018 Wiley Periodicals, Inc.

A comparison between two lingual orthodontic brackets in terms of speech performance and patients' acceptance in correcting Class II, Division 1 malocclusion: a randomized controlled trial

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Samiha Haj-Younis

Full Text Available ABSTRACT Objective: To compare speech performance and levels of oral impairment between two types of lingual brackets. Methods: A parallel-group randomized controlled trial was carried out on patients with Class II, Division 1 malocclusion treated at the University of Hama School of Dentistry in Hama, Syria. A total of 46 participants (mean age: 22.3 ± 2.3 years with maxillary dentoalveolar protrusion were randomly distributed into two groups with 23 patients each (1:1 allocation ratio. Either STb (Ormco or 7th Generation (Ormco lingual brackets were applied. Fricative sound/s/ spectrograms were analyzed directly before intervention (T0, one week following premolar extraction prior to bracket placement (T1, within 24 hours of bracket bonding (T2, one month after (T3, and three months after (T4 bracket placement. Patients′ acceptance was assessed by means of standardized questionnaires. Results: After bracket placement, significant deterioration in articulation was recorded at all assessment times in the 7th Generation group, and up to T3 in the STb group. Significant intergroup differences were detected at T2 and T3. No statistically significant differences were found between the two groups in reported tongue irritation levels, whereas chewing difficulty was significantly higher in the 7th Generation group one month after bracket placement. Conclusions: 7th Generation brackets have more interaction with sound production than STb ones. Although patients in both groups complained of some degree of oral impairment, STb appliances appeared to be more comfortable than the 7th Generation ones, particularly within the first month of treatment.

A comparison between two lingual orthodontic brackets in terms of speech performance and patients' acceptance in correcting Class II, Division 1 malocclusion: a randomized controlled trial

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Haj-Younis, Samiha; Khattab, Tarek Z.; Hajeer, Mohammad Y.; Farah, Hassan

2016-01-01

ABSTRACT Objective: To compare speech performance and levels of oral impairment between two types of lingual brackets. Methods: A parallel-group randomized controlled trial was carried out on patients with Class II, Division 1 malocclusion treated at the University of Hama School of Dentistry in Hama, Syria. A total of 46 participants (mean age: 22.3 ± 2.3 years) with maxillary dentoalveolar protrusion were randomly distributed into two groups with 23 patients each (1:1 allocation ratio). Either STb (Ormco) or 7th Generation (Ormco) lingual brackets were applied. Fricative sound/s/ spectrograms were analyzed directly before intervention (T0), one week following premolar extraction prior to bracket placement (T1), within 24 hours of bracket bonding (T2), one month after (T3), and three months after (T4) bracket placement. Patients′ acceptance was assessed by means of standardized questionnaires. Results: After bracket placement, significant deterioration in articulation was recorded at all assessment times in the 7th Generation group, and up to T3 in the STb group. Significant intergroup differences were detected at T2 and T3. No statistically significant differences were found between the two groups in reported tongue irritation levels, whereas chewing difficulty was significantly higher in the 7th Generation group one month after bracket placement. Conclusions: 7th Generation brackets have more interaction with sound production than STb ones. Although patients in both groups complained of some degree of oral impairment, STb appliances appeared to be more comfortable than the 7th Generation ones, particularly within the first month of treatment. PMID:27653268

A comparison between two lingual orthodontic brackets in terms of speech performance and patients' acceptance in correcting Class II, Division 1 malocclusion: a randomized controlled trial.

Science.gov (United States)

Haj-Younis, Samiha; Khattab, Tarek Z; Hajeer, Mohammad Y; Farah, Hassan

2016-01-01

To compare speech performance and levels of oral impairment between two types of lingual brackets. A parallel-group randomized controlled trial was carried out on patients with Class II, Division 1 malocclusion treated at the University of Hama School of Dentistry in Hama, Syria. A total of 46 participants (mean age: 22.3 ± 2.3 years) with maxillary dentoalveolar protrusion were randomly distributed into two groups with 23 patients each (1:1 allocation ratio). Either STb (Ormco) or 7th Generation (Ormco) lingual brackets were applied. Fricative sound/s/ spectrograms were analyzed directly before intervention (T0), one week following premolar extraction prior to bracket placement (T1), within 24 hours of bracket bonding (T2), one month after (T3), and three months after (T4) bracket placement. Patients' acceptance was assessed by means of standardized questionnaires. After bracket placement, significant deterioration in articulation was recorded at all assessment times in the 7th Generation group, and up to T3 in the STb group. Significant intergroup differences were detected at T2 and T3. No statistically significant differences were found between the two groups in reported tongue irritation levels, whereas chewing difficulty was significantly higher in the 7th Generation group one month after bracket placement. 7th Generation brackets have more interaction with sound production than STb ones. Although patients in both groups complained of some degree of oral impairment, STb appliances appeared to be more comfortable than the 7th Generation ones, particularly within the first month of treatment.

The Impact of Achieve3000 on Elementary Literacy Outcomes: Evidence from a Two-Year Randomized Control Trial

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Hill, Darryl V.; Lenard, Matthew A.; Page, Lindsay Coleman

2016-01-01

School districts are increasingly adopting technology-based resources in an attempt to improve student achievement. This paper reports the two-year results from randomized control trial of Achieve3000 in the Wake County Public School System (WCPSS) in Raleigh, North Carolina. Achieve3000 is an early literacy program that differentiates non-fiction…

A Randomized Controlled Trial of Hanen's "More than Words" in Toddlers with Early Autism Symptoms

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Carter, Alice S.; Messinger, Daniel S.; Stone, Wendy L.; Celimli, Seniz; Nahmias, Allison S.; Yoder, Paul

2011-01-01

Background: This randomized controlled trial compared Hanen's "More than Words" (HMTW), a parent-implemented intervention, to a "business as usual" control group. Methods: Sixty-two children (51 boys and 11 girls; M age = 20 months; SD = 2.6) who met criteria for autism spectrum disorders (ASD) and their parents participated in the study. The HMTW…

Involving fathers in teaching youth about farm tractor seatbelt safety--a randomized control study.

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Jinnah, Hamida Amirali; Stoneman, Zolinda; Rains, Glen

2014-03-01

Farm youth continue to experience high rates of injury and deaths as a result of agricultural activities. Farm machinery, especially tractors, is the most common cause of casualties to youth. A Roll-Over Protection Structure (ROPS) along with a fastened seatbelt can prevent almost all injuries and fatalities from tractor overturns. Despite this knowledge, the use of seatbelts by farmers on ROPS tractors remains low. This study treats farm safety as a family issue and builds on the central role of parents as teachers and role models of farm safety for youth. This research study used a longitudinal, repeated-measures, randomized-control design in which youth 10-19 years of age were randomly assigned to either of two intervention groups (parent-led group and staff-led group) or the control group. Fathers in the parent-led group were less likely to operate ROPS tractors without a seatbelt compared with other groups. They were more likely to have communicated with youth about the importance of wearing seatbelts on ROPS tractors. Consequently, youth in the parent-led group were less likely to operate a ROPS tractor without a seatbelt than the control group at post-test. This randomized control trial supports the effectiveness of a home-based, father-led farm safety intervention as a promising strategy for reducing youth as well as father-unsafe behaviors (related to tractor seatbelts) on the farm. This intervention appealed to fathers' strong motivation to practice tractor safety for the sake of their youth. Involving fathers helped change both father as well as youth unsafe tractor-seatbelt behaviors. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

CoDuSe group exercise programme improves balance and reduces falls in people with multiple sclerosis: A multi-centre, randomized, controlled pilot study.

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Carling, Anna; Forsberg, Anette; Gunnarsson, Martin; Nilsagård, Ylva

2017-09-01

Imbalance leading to falls is common in people with multiple sclerosis (PwMS). To evaluate the effects of a balance group exercise programme (CoDuSe) on balance and walking in PwMS (Expanded Disability Status Scale, 4.0-7.5). A multi-centre, randomized, controlled single-blinded pilot study with random allocation to early or late start of exercise, with the latter group serving as control group for the physical function measures. In total, 14 supervised 60-minute exercise sessions were delivered over 7 weeks. Pretest-posttest analyses were conducted for self-reported near falls and falls in the group starting late. Primary outcome was Berg Balance Scale (BBS). A total of 51 participants were initially enrolled; three were lost to follow-up. Post-intervention, the exercise group showed statistically significant improvement ( p = 0.015) in BBS and borderline significant improvement in MS Walking Scale ( p = 0.051), both with large effect sizes (3.66; -2.89). No other significant differences were found between groups. In the group starting late, numbers of falls and near falls were statistically significantly reduced after exercise compared to before ( p balance and reduced perceived walking limitations, compared to no exercise. The intervention reduced falls and near falls frequency.

The effects of probiotic supplements on insulin resistance in gestational diabetes mellitus: a double-blind randomized controlled trial.

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Kijmanawat, Athasit; Panburana, Panyu; Reutrakul, Sirimon; Tangshewinsirikul, Chayada

2018-05-20

To evaluate the effect of probiotic supplements on insulin resistance in pregnant women with diet-controlled gestational diabetes mellitus. A randomized, double-blind, placebo-controlled trial was conducted between June 2016 and February 2017. Pregnant women with diet-controlled gestational diabetes mellitus were enrolled in the study at 24-28 weeks of gestation and randomized to receive either probiotic supplements containing Bifidobacterium and Lactobacillus or placebo daily for four consecutive weeks. Primary outcomes were mean differences in insulin resistance (HOMA-IR), fasting insulin and fasting plasma glucose between the two groups. Secondary outcomes were changes in maternal weight after the intervention. Data from 28 patients in the probiotic group and 29 in the placebo group were analyzed. The changes in metabolic parameters after randomization indicated significant improvement in glucose metabolism in the probiotic group compared to the placebo group, including fasting plasma glucose (0.68 ± 5.88 vs. 4.620 ± 7.78 mg/dL, mean difference, MD, -3.94 mg/dL (95% CI -7.62, -0.27), p-value 0.034), fasting plasma insulin (1.11 ± 1.71 vs. 3.77 ± 1.70 mIU/L, MD -2.67 mIU/L (95%CI -3.57, -1.76), p-value 0.001) and HOMA-IR (0.25 ± 0.37 vs. 0.89 ± 0.46, MD -0.63 (95% CI -0.86, -0.41), p-value 0.001). Weight gain during randomization was similar between the two groups. Four weeks of probiotic supplements in women with diet-controlled gestational diabetes in the late second- and early third-trimester lowered fasting glucose and increased insulin sensitivity. Probiotic supplements may be considered as an adjunct treatment for glycemic control in these patients. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

The effects of Internet-based exercise compared with supervised group exercise in people with type 2 diabetes: a randomized controlled study.

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Akinci, Buket; Yeldan, Ipek; Satman, Ilhan; Dirican, Ahmet; Ozdincler, Arzu Razak

2018-06-01

To compare the effects of Internet-based exercise on glycaemic control, blood lipids, body composition, physical activity level, functional capacity, and quality of life with supervised group exercise in patients with type 2 diabetes. Single-blind, randomized controlled study. A Faculty of Health Sciences. A total of 65 patients with type 2 diabetes (47 women, 18 men). Group A ( n = 22), control group - physical activity counselling once with a brochure. Group B ( n = 22), supervised group-based exercise, three days per week for eight weeks. Group C ( n = 21), Internet-based exercise following the same programme via a website. Primary outcomes - glycosylated haemoglobin, fasting blood glucose, high-density and low-density lipoprotein, triglyceride, and cholesterol. Secondary outcomes - waist and hip circumferences, body mass index, number of steps, six-minute walking test, and Euro-Quality of Life-5 Dimension. After treatment, glycaemic control (mean change for Group B; Group C; -0.80%, -0.91%, P = 0.003), waist circumference (-4.23 cm, 5.64 cm, P = 0.006), and quality of life (0.26, 0.15, P = 0.013) significantly improved in both training groups compared with the control group. Fasting blood glucose (-46.86 mg/dL, P = 0.009) and hip circumference (-2.7 cm, P = 0.011) were significantly decreased in Group B and total cholesterol (-16.4 mg/dL, P = 0.028), six-minute walking distance (30.5 m, P = 0.01), and number of steps (1258.05, P = 0.023) significantly improved in Group C compared with control group. Group B and Group C changed with equal magnitude. In type 2 diabetes, supervised group-based and Internet-based exercise can improve equally glycaemic control, waist circumference, and quality of life, and both are better than simply counselling.

Effectiveness of two home ergonomic programs in reducing pain and enhancing quality of life in informal caregivers of post-stroke patients: A pilot randomized controlled clinical trial.

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de Araújo Freitas Moreira, Karen Lucia; Ábalos-Medina, Gracia María; Villaverde-Gutiérrez, Carmen; Gomes de Lucena, Neide María; Belmont Correia de Oliveira, Anderson; Pérez-Mármol, José Manuel

2018-02-13

Informal caregivers of post-stroke patients usually undergo high levels of pain and stress and have a reduced quality of life. To evaluate the effectiveness of two home ergonomic interventions aimed at reducing pain intensity and perceived stress and enhancing the quality of life in informal caregivers of chronic post-stroke patients. A randomized single-blind controlled clinical trial was conducted, with a sample of 33 informal caregivers of patients with stroke. Three groups were included: one received postural hygiene training and kinesiotherapy, for 12 weeks, two days a week, one hour per session; another received adaptation of the home environment, and the third was a control group. Pain intensity, stress level and general quality of life were evaluated at three-time points: pre-intervention, post-intervention, and after a follow-up period of three months. Neck pain decreased in the two experimental groups, and increased in the control group. Pain in the shoulders and knees was alleviated in the group that received postural hygiene and kinesiotherapy. In addition, regarding quality of life, this group obtained an improvement in the physical health dimension, while the home adaptation group reported improved social relationships. These results suggest that 12 weeks of training in postural hygiene, combined with kinesiotherapy, and home adaptations can reduce pain and improve several aspects of the quality of life of this population. CLINICALTRIALS. NCT03284580. Copyright © 2018 Elsevier Inc. All rights reserved.

[Sacroiliac joint injury treated with oblique insertion at anatomical points: a randomized controlled trial].

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Kuang, Jiayi; Li, Yuxuan; He, Yufeng; Gan, Lin; Wang, Aiming; Chen, Yanhua; Li, Xiaoting; Guo, Lin; Tang, Rongjun

2016-04-01

To compare the effects of oblique insertion at anatomical points and conventional acupuncture for sacroiliac joint injury. Eighty patients were randomly divided into an observation group and a control group, 40 cases in each one. In the observation group, oblique insertion therapy at anatomical points was used, and the 9 points of equal division (anatomical points) marked by palpating the anatomical symbol were treated as the insertion acupoints. In the control group, conventional acupuncture was applied, and perpendicular insertion was adopted at Huantiao (GB 30), Zhibian (BL 54) and Weizhong (BL 40), etc. In the two groups, the! treatment was given once a day and 5 times per week. Ten treatments were made into one course and two courses were required. The clinical effects, the changes of visual analogue scale (VAS) and Oswestry dysfunctional index. (ODI) before and after treatment were observed in the two groups. The total effective rate of the observation group was 90.0% (36/40), which was better than 72.5% (29/40) of the control group (P sacroiliac joint injury is superior to that of conventional acupuncture, which can effectively relieve pain and improve the disfunction.

An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study—A Two-Year Randomized Controlled Clinical Trial

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Burguera, Bartolomé; Jesús Tur, Juan; Escudero, Antonio Jorge; Alos, María; Pagán, Alberto; Cortés, Baltasar; González, Xavier Francesc; Soriano, Joan B.

2015-01-01

Bariatric surgery is currently the most effective therapy to induce weight loss in morbidly obese patients. Objective. This controlled, clinical trial with a two-year intervention was aimed at comparing the efficacy of two nonsurgical approaches versus bariatric surgery, on body weight changes and metabolic parameters in morbidly obese patients. Methods. Patients were randomized to an Intensive Lifestyle Intervention (ILI) (n = 60) or Conventional Obesity Therapy (COT) (n = 46). The ILI group received behavioral therapy and nutritional counseling. The COT group received standard medical treatment. They were compared with a third group, Surgical Obesity Group (SOG) (n = 37). Results. Patients who received ILI had a greater percentage of weight loss than patients receiving COT (−11.3% versus −1.6%; p < 0.0044). Interestingly 31.4% of patients included in the ILI group were no longer morbidly obese after just six months of intervention, increasing to 44.4% after 24 months of intervention. The percentage weight loss in SOG was −29.6% after that same period of time. Conclusions. ILI was associated with significant weight loss when compared to COT, in a group of patients with obesity. An ILI approach could be an alternative therapy to patients with obesity, who are not candidates to undergo bariatric surgery. This trial is registered with EudraCT 2009-013737-24. PMID:26257780

An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study—A Two-Year Randomized Controlled Clinical Trial

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Bartolomé Burguera

2015-01-01

Full Text Available Bariatric surgery is currently the most effective therapy to induce weight loss in morbidly obese patients. Objective. This controlled, clinical trial with a two-year intervention was aimed at comparing the efficacy of two nonsurgical approaches versus bariatric surgery, on body weight changes and metabolic parameters in morbidly obese patients. Methods. Patients were randomized to an Intensive Lifestyle Intervention (ILI (n=60 or Conventional Obesity Therapy (COT (n=46. The ILI group received behavioral therapy and nutritional counseling. The COT group received standard medical treatment. They were compared with a third group, Surgical Obesity Group (SOG (n=37. Results. Patients who received ILI had a greater percentage of weight loss than patients receiving COT (−11.3% versus −1.6%; p<0.0044. Interestingly 31.4% of patients included in the ILI group were no longer morbidly obese after just six months of intervention, increasing to 44.4% after 24 months of intervention. The percentage weight loss in SOG was −29.6% after that same period of time. Conclusions. ILI was associated with significant weight loss when compared to COT, in a group of patients with obesity. An ILI approach could be an alternative therapy to patients with obesity, who are not candidates to undergo bariatric surgery. This trial is registered with EudraCT 2009-013737-24.

Depressive symptoms and gestational length among pregnant adolescents: Cluster randomized control trial of CenteringPregnancy® plus group prenatal care.

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Felder, Jennifer N; Epel, Elissa; Lewis, Jessica B; Cunningham, Shayna D; Tobin, Jonathan N; Rising, Sharon Schindler; Thomas, Melanie; Ickovics, Jeannette R

2017-06-01

Depressive symptoms are associated with preterm birth among adults. Pregnant adolescents have high rates of depressive symptoms and low rates of treatment; however, few interventions have targeted this vulnerable group. Objectives are to: (a) examine impact of CenteringPregnancy® Plus group prenatal care on perinatal depressive symptoms compared to individual prenatal care; and (b) determine effects of depressive symptoms on gestational age and preterm birth among pregnant adolescents. This cluster-randomized controlled trial was conducted in 14 community health centers and hospitals in New York City. Clinical sites were randomized to receive standard individual prenatal care (n = 7) or CenteringPregnancy® Plus group prenatal care (n = 7). Pregnant adolescents (ages 14-21, N = 1,135) completed the Center for Epidemiologic Studies Depression Scale during pregnancy (second and third trimesters) and postpartum (6 and 12 months). Gestational age was obtained from medical records, based on ultrasound dating. Intention to treat analyses were used to examine objectives. Adolescents at clinical sites randomized to CenteringPregnancy® Plus experienced greater reductions in perinatal depressive symptoms compared to those at clinical sites randomized to individual care (p = .003). Increased depressive symptoms from second to third pregnancy trimester were associated with shorter gestational age at delivery and preterm birth (<37 weeks gestation). Third trimester depressive symptoms were also associated with shorter gestational age and preterm birth. All p < .05. Pregnant adolescents should be screened for depressive symptoms prior to third trimester. Group prenatal care may be an effective nonpharmacological option for reducing depressive symptoms among perinatal adolescents. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Comparison of two approaches in achieving smoking abstinence among patients in an outpatient clinic: a phase 2 randomized controlled trial

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Ka Yan Ho

2018-03-01

Full Text Available Background Having a disease and requiring medical attention present an excellent 'teachable moment' for smoking cessation interventions. However, nicotine is addictive and quitting is difficult, with a high rate of relapse, particularly among chronic smokers. Our previous smoking cessation projects in the community have revealed that many smokers who are reluctant to quit are interested in reducing the number of cigarettes they smoke per day. Therefore, smoking reduction may be an important alternative strategy for promoting smoking cessation. This Phase 2 randomized controlled trial of smokers who had medical follow-ups in an outpatient clinic compared the effectiveness of two approaches to smoking cessation: quitting immediately and cutting down to quit. Methods A total of 100 subjects were randomized into two groups, 50 in the quit immediately group, who received an intervention on abruptly quitting, and 50 in the cut down to quit group, who received an intervention on gradual reduction. All subjects were followed up at 6 and 12 months via telephone, and their smoking status was assessed. The primary outcomes were self-reported 7-day point prevalence of abstinence at 6 and 12 months. Intention-to-treat analysis was employed. Results On average, subjects had smoked 11.31 cigarettes per day over 37 years and 96% had mild nicotine dependence. At the 6-month follow-up, the self-reported quit rate of subjects in the quit immediately group was significantly higher than in the cut down to quit group (18.0% vs. 4.0%, p = 0.04. However, this difference was not significant at the 12-month follow-up (12.0% vs. 4.0%, p = 0.16. Conclusions These data suggest that quitting immediately might be more effective than cutting down to quit in smokers who need to quit sooner, such as those with diseases requiring medical attention. Nevertheless, the effectiveness of the cut down to quit approach requires further testing.

Comparison of two extracorporeal shock wave therapy techniques for the treatment of painful subcalcaneal spur. A randomized controlled study.

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Tornese, Davide; Mattei, Enrico; Lucchesi, Giampaolo; Bandi, Marco; Ricci, Gabriele; Melegati, Gianluca

2008-09-01

To describe and compare two extracorporeal shock wave therapy techniques for the treatment of painful subcalcaneal spur. Random assignment to two groups of treatment with two and eight months follow-up. The data were collected in outpatients. Forty-five subjects with a history of at least six months of heel pain were studied. Each subject received a three-session ultrasound-guided extracorporeal shock wave therapy (performed weekly). Perpendicular technique was used in group A (n=22, mean age 59.3 +/- 12 years) and tangential technique was used in group B (n= 23, mean age 58.8 +/- 12.3 years). Mayo Clinical Scoring System was used to evaluate each subject before the treatment and at two and eight months follow-up. Mayo Clinical Scoring System pretreatment scores were homogeneous between the groups (group A 55.2 +/-18.7; group B 53.5 +/- 20; P>0.05). In both groups there was a significant (Pwave therapy. The tangential technique was found to be better tolerated as regards treatment-induced pain, allowing higher energy dosages to be used.

Exploring the efficacy of an acceptance, mindfulness & compassionate-based group intervention for women struggling with their weight (Kg-Free): A randomized controlled trial.

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Palmeira, Lara; Pinto-Gouveia, José; Cunha, Marina

2017-05-01

This randomized-controlled trial aims to test the efficacy of a group intervention (Kg-Free) for women with overweight or obesity based on mindfulness, ACT and compassion approaches. The intervention aimed to reduce weight self-stigma and unhealthy eating patterns and increase quality-of-life (QoL). Seventy-three women, aged between 18 and 55 years old, with BMI ≥25 without binge-eating seeking weight loss treatment were randomly assigned to intervention or control groups. Kg-Free comprises 10 weekly group sessions plus 2 booster fortnightly sessions, of 2h30 h each. The control group maintained Treatment as Usual (TAU). Data was collected at baseline and at the end of the Kg-Free intervention. Overall, participants enrolled in Kg-Free found the intervention to be very important and helpful when dealing with their weight-related unwanted internal experiences. Moreover, when compared with TAU, the Kg-Free group revealed a significant increased health-related QoL and physical exercise and a reduction of weight self-stigma, unhealthy eating behaviors, BMI, self-criticism, weight-related experiential avoidance and psychopathological symptoms at post-treatment. Results for self-compassion showed a trend towards significance, whereas no significant between-groups differences were found for mindfulness. Taken together, evidence was found for Kg-Free efficacy in reducing weight-related negative experiences and promoting healthy behaviors, psychological functioning, and QoL. Copyright © 2017 Elsevier Ltd. All rights reserved.

The Efficacy of Acupuncture on Anthropometric Measures and the Biochemical Markers for Metabolic Syndrome: A Randomized Controlled Pilot Study

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Mingjuan Han

2017-01-01

Full Text Available Background. Many previous studies have shown the potential therapeutic effect of acupuncture for metabolic syndrome (MetS. However, most of these studies were limited by short durations of observation and a lack of sham acupuncture as control. We designed a randomized controlled trial, used sham acupuncture as the control, and evaluated the efficacy over 12 weeks of treatment and 12 weeks of follow-up. Methods/Design. The study was designed as a multicentre, parallel-group, randomized, double-blinded trial. 40 patients were randomly assigned to two groups: treatment group (treated with acupuncture and control group (treated with sham acupuncture. Outcomes were measured at 4, 8, and 12 weeks and 3 months after treatment. Results. 33 participants (17 in acupuncture group and 16 in control group completed the treatment and the follow-up. Decreases from baseline in mean waist circumference (WC and weight at the end of treatment were 4.85 cm (95% CI [2.405,5.595] and 4.00 kg (95% CI [1.6208,4.4498] in acupuncture group and 1.62 cm and 1.64 kg in control group (P<0.01. The changes in mean glycosylated haemoglobin (HbA1c, triglycerides (TG, total cholesterol (TC, and blood pressure in acupuncture group were greater than the changes in control group (P<0.05, P<0.01. Conclusion. Acupuncture decreases WC, HC, HbA1c, TG, and TC values and blood pressure in MetS.

Increasing Physical Activity in Mothers Using Video Exercise Groups and Exercise Mobile Apps: Randomized Controlled Trial.

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Mascarenhas, Maya Nina; Chan, June Maylin; Vittinghoff, Eric; Van Blarigan, Erin Lynn; Hecht, Frederick

2018-05-18

Women significantly decrease their activity levels in the transition to motherhood. Digital health technologies are low cost, scalable, and can provide an effective delivery mechanism for behavior change. This is the first study that examines the use of videoconferencing and mobile apps to create exercise groups for mothers. The aim of the study was to test the feasibility, acceptability, and effectiveness of an individually adaptive and socially supportive physical activity intervention incorporating videoconferencing and mobile apps for mothers. The Moms Online Video Exercise Study was an 8-week, 2-armed, Web-based randomized trial comparing the effectiveness of a group exercise intervention with a waitlist control. Healthy mothers with at least 1 child under the age of 12 years were recruited through Facebook and email listservs. Intervention participants joined exercise groups using videoconferencing (Google Hangouts) every morning on weekdays and exercised together in real time, guided by exercise mobile apps (eg, Nike+, Sworkit) of their choice. Waitlist control participants had access to recommended mobile apps and an invitation to join an exercise group after the 8-week study period. Main outcomes assessed included changes in self-reported moderate, vigorous, and moderate to vigorous physical activity (MVPA) minutes per week in aggregate and stratified by whether women met Centers for Disease Control and Prevention guidelines for sufficient aerobic activity at baseline. Outcomes were measured through self-assessed Web-based questionnaires at baseline and 8 weeks. The intervention was effective at increasing exercise for inactive women and proved to be feasible and acceptable to all participants. A total of 64 women were randomized, 30 to intervention and 34 to control. Women attended 2.8 sessions per week. There was a strong, but not statistically significant, trend toward increasing moderate, vigorous, and MVPA minutes for all women. As hypothesized, in

Small laser spot versus standard laser spot photodynamic therapy for idiopathic choroidal neovascularization: a randomized controlled study.

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Li, Xiao-xin; Tao, Yong

2012-12-01

Idiopathic choroidal neovascularization (ICNV) affects young patients and thus may have a significant impact on vision and life quality over a patient's lifespan. This study was designed to compare the visual outcome and retinal pigment epithelium (RPE) damage after photodynamic therapy (PDT) with small laser spot and PDT with standard laser spot for idiopathic choroidal neovascularization (ICNV). This was a randomized controlled study. Fifty-two patients with ICNV were enrolled and randomly divided into a study group (small laser spot PDT, n = 27) and a control group (standard laser spot PDT, n = 25). Best corrected visual acuity (BCVA), optic coherence tomography (OCT) and fluorescein angiography (FA) findings were the main measurements. The patients were followed up 1 week, 1, 3, 6, 9 months and 1 year after PDT. BCVA improvement was statistically significantly higher in the study group than the control group at 6-month ((25.53 ± 15.01) letters vs. (14.71 ± 11.66) letters, P = 0.025) and 9-month follow-ups ((27.53 ± 17.78) letters vs. (15.59 ± 12.21) letters, P = 0.039). At 3- and 6-month follow-ups, the quadrants of RPE damage between the two groups varied significantly (P laser spot PDT group than in the standard laser spot PDT group for ICNV.

The Efficacy of Parent-Child Interaction Therapy with Chinese Families: Randomized Controlled Trial

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Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan

2015-01-01

Objective: This study aimed to examine the efficacy of the Parent-Child Interaction Therapy (PCIT) in Hong Kong Chinese families, using randomized controlled trial design. Methods: The participants included 111 Hong Kong Chinese parents with children aged 2--7 years old, who were randomized into the intervention group (n = 54) and control group (n…

Decision aid on breast cancer screening reduces attendance rate: results of a large-scale, randomized, controlled study by the DECIDEO group

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Bourmaud, Aurelie; Soler-Michel, Patricia; Oriol, Mathieu; Regnier, Véronique; Tinquaut, Fabien; Nourissat, Alice; Bremond, Alain; Moumjid, Nora; Chauvin, Franck

2016-01-01

Controversies regarding the benefits of breast cancer screening programs have led to the promotion of new strategies taking into account individual preferences, such as decision aid. The aim of this study was to assess the impact of a decision aid leaflet on the participation of women invited to participate in a national breast cancer screening program. This Randomized, multicentre, controlled trial. Women aged 50 to 74 years, were randomly assigned to receive either a decision aid or the usual invitation letter. Primary outcome was the participation rate 12 months after the invitation. 16 000 women were randomized and 15 844 included in the modified intention-to-treat analysis. The participation rate in the intervention group was 40.25% (3174/7885 women) compared with 42.13% (3353/7959) in the control group (p = 0.02). Previous attendance for screening (RR = 6.24; [95%IC: 5.75-6.77]; p < 0.0001) and medium household income (RR = 1.05; [95%IC: 1.01-1.09]; p = 0.0074) were independently associated with attendance for screening. This large-scale study demonstrates that the decision aid reduced the participation rate. The decision aid activate the decision making process of women toward non-attendance to screening. These results show the importance of promoting informed patient choices, especially when those choices cannot be anticipated. PMID:26883201

A Randomized Controlled Trial Examining the Effects of Reflexology on Children With Functional Constipation.

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Canbulat Sahiner, Nejla; Demirgoz Bal, Meltem

Functional constipation is a common problem in Turkey that affects up to 10% of children. Reflexologists claim that reflexology can be beneficial in the treatment of constipation. The aim of this randomized controlled study was to determine the effectiveness of reflexology in treating functional constipation in children. Thirty-seven children who were referred to a pediatrician with functional constipation as defined by the Rome III criteria were recruited to the study. After the physician's diagnosis, two groups (intervention/control) were created. The intervention and control groups comprised 17 and 20 children, respectively. Each child in the intervention group was given a foot massage for 10 minutes five times a week, and toilet/diet/motivation training was given to their parents. The test period lasted for 4 weeks. Toilet/diet/motivation training was undertaken for 30 minutes once per week (for a total of 4 weeks) in an interactive manner. The parents of children in the control group received equivalent toilet/diet/motivation training only. No significant differences in terms of feces frequency and feces consistency were noted between the intervention and control groups (p > .05). This study sample showed that only toilet/diet/motivation training had potential benefit for treating functional constipation in children. Further larger randomized trials are required to establish whether there are benefits to foot message in the treatment of functional constipation in children.

Effectiveness of Two Web-Based Interventions for Chronic Cancer-Related Fatigue Compared to an Active Control Condition: Results of the "Fitter na kanker" Randomized Controlled Trial.

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Bruggeman-Everts, Fieke Z; Wolvers, Marije D J; van de Schoot, Rens; Vollenbroek-Hutten, Miriam M R; Van der Lee, Marije L

2017-10-19

Approximately one third of all patients who have been successfully treated for cancer suffer from chronic cancer-related fatigue (CCRF). Effective and easily accessible interventions are needed for these patients. The current paper reports on the results of a 3-armed randomized controlled trial investigating the clinical effectiveness of two different guided Web-based interventions for reducing CCRF compared to an active control condition. Severely fatigued cancer survivors were recruited via online and offline channels, and self-registered on an open-access website. After eligibility checks, 167 participants were randomized via an embedded automated randomization function into: (1) physiotherapist-guided Ambulant Activity Feedback (AAF) therapy encompassing the use of an accelerometer (n=62); (2) psychologist-guided Web-based mindfulness-based cognitive therapy (eMBCT; n=55); or (3) an unguided active control condition receiving psycho-educational emails (n=50). All interventions lasted nine weeks. Fatigue severity was self-assessed using the Checklist Individual Strength - Fatigue Severity subscale (primary outcome) six times from baseline (T0b) to six months (T2). Mental health was self-assessed three times using the Hospital Anxiety and Depression Scale and Positive and Negative Affect Schedule (secondary outcome). Treatment dropout was investigated. Multiple group latent growth curve analysis, corrected for individual time between assessments, showed that fatigue severity decreased significantly more in the AAF and eMBCT groups compared to the psycho-educational group. The analyses were checked by a researcher who was blind to allocation. Clinically relevant changes in fatigue severity were observed in 66% (41/62) of patients in AAF, 49% (27/55) of patients in eMBCT, and 12% (6/50) of patients in psycho-education. Dropout was 18% (11/62) in AAF, mainly due to technical problems and poor usability of the accelerometer, and 38% (21/55) in eMBCT, mainly due to

Effects of exercise and diet in nonobese asthma patients - a randomized controlled trial

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Tønnesen, Louise Lindhardt; Meteran, Howraman; Hostrup, Morten

2018-01-01

BACKGROUND: Behavioral interventions focusing on exercise and healthy diet improve asthma control in obese patients with asthma, but whether these interventions can lead to improvements in nonobese patients remains unclear. OBJECTIVES: In a randomized, controlled parallel-group design, we studied...... the effects of an 8-week intervention of either exercise (high-intensity interval training), diet (high protein/low glycemic index), or a combination of the 2, on asthma control and clinical outcomes in nonobese patients with asthma. METHODS: Nonobese adult patients with asthma (n = 149) were randomized to 1...... of 4 groups: an exercise group, a diet group, an exercise + diet group, or a control group. Outcomes included Asthma Control Questionnaire (ACQ) score, asthma-related quality-of-life (Asthma-Related Quality-of-Life Questionnaire [AQLQ]) score, inflammatory cell counts in induced sputum, FEV1...

[Migraine without aura treated with balance acupuncture therapy:a randomized controlled trial].

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Wang, Jinzhong; Qin, Xiaolan; Xie, Wenyuan; Wang, Wenyuan

2017-08-12

To assess the effect of balance acupuncture for migraine without aura. Blind evaluation was conducted. Forty patients with migraine without aura were randomized into an observation group and a control group, 19 cases in each one with 1 patient dropped out respectively. In the observation group, Toutongxue , the middle point was used in the hollow before the 1, 2 metatarsal combination, and in the control group, a sham point was applied in the hollow before the 3, 4 metatarsal combination. The manipulation in the two groups was the same. The treatment was given for 4 weeks, once a day, 5 times a week. The comprehensive score and visual analogue scale (VAS) were used before and after treatment, as well as 4 weeks after treatment. The comprehensive score and VAS score after treatment in the observation group decreased after treatment (both P 0.05). All the indices in the observation group after treatment and at follow-up were lower than those in the control group (all P 0.05). Balance acupuncture at Toutongxue achieves obvious effect for migraine without aura, which can relieve pain.

Diabetes Support Groups Improve Patient’s Compliance and Control Blood Glucose Levels

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Zamrotul Izzah

2013-09-01

Full Text Available Providing information is not enough to improve diabetic patient’s compliance and achieve goals of therapy. Patient’s good awareness as well as emotional and social supports from family and community may play an important role to improve their compliance and clinical outcomes. Therefore, diabetes support groups were developed and each support group consisted of two pharmacists, two nurses, diabetic patients and their family members. A total of 70 type 2 diabetic patient’s were enrolled and randomized into support group 1 and support group 2. Patients in the group 1 received information leaflets only, while patient in the group 2 received pharmacist counselling and information leaflets at each meeting. Patient’s awareness of diabetes and compliance with medications were assessed by a short questionnaire at baseline and final follow-up. Blood glucose and cholesterol levels were also evaluated in both groups. At the end of study, the overall patient’s awareness and compliance improved by 61.5%. The random and fasting blood glucose levels decreased over than 30% in the group 2 and around 14% in the group 1. This study reveals that collaboration between health care professionals and community in the diabetes support group might help diabetic patients to increase their knowledge and compliance with the diabetes therapy as well as glycaemic control.

Group parent-child interaction therapy: A randomized control trial for the treatment of conduct problems in young children.

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Niec, Larissa N; Barnett, Miya L; Prewett, Matthew S; Shanley Chatham, Jenelle R

2016-08-01

Although efficacious interventions exist for childhood conduct problems, a majority of families in need of services do not receive them. To address problems of treatment access and adherence, innovative adaptations of current interventions are needed. This randomized control trial investigated the relative efficacy of a novel format of parent-child interaction therapy (PCIT), a treatment for young children with conduct problems. Eighty-one families with 3- to 6-year-old children (71.6% boys, 85.2% White) with diagnoses of oppositional defiant or conduct disorder were randomized to individual PCIT (n = 42) or the novel format, Group PCIT. Parents completed standardized measures of children's conduct problems, parenting stress, and social support at intake, posttreatment, and 6-month follow-up. Therapist ratings, parent attendance, and homework completion provided measures of treatment adherence. Throughout treatment, parenting skills were assessed using the Dyadic Parent-Child Interaction Coding System. Parents in both group and individual PCIT reported significant improvements from intake to posttreatment and follow-up in their children's conduct problems and adaptive functioning, as well as significant decreases in parenting stress. Parents in both treatment conditions also showed significant improvements in their parenting skills. There were no interactions between time and treatment format. Contrary to expectation, parents in Group PCIT did not experience greater social support or treatment adherence. Group PCIT was not inferior to individual PCIT and may be a valuable format to reach more families in need of services. Future work should explore the efficiency and sustainability of Group PCIT in community settings. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Group Parent-Child Interaction Therapy: A Randomized Control Trial for the Treatment of Conduct Problems in Young Children

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Niec, Larissa N.; Barnett, Miya L.; Prewett, Matthew S.; Shanley, Jenelle

2016-01-01

Objective Although efficacious interventions exist for childhood conduct problems, a majority of families in need of services do not receive them. To address problems of treatment access and adherence, innovative adaptations of current interventions are needed. This randomized control trial investigated the relative efficacy of a novel format of parent-child interaction therapy (PCIT), a treatment for young children with conduct problems. Methods Eighty-one families with three- to six-year-old children (71.6% male; 85.2% Caucasian) with diagnoses of oppositional defiant or conduct disorder were randomized to individual PCIT (n = 42) or the novel format, group PCIT. Parents completed standardized measures of children’s conduct problems, parenting stress, and social support at intake, posttreatment, and six-month follow-up. Therapist ratings, parent attendance, and homework completion provided measures of treatment adherence. Throughout treatment, parenting skills were assessed using the Dyadic Parent-Child Interaction Coding System. Results Parents in both group and individual PCIT reported significant improvements from intake to posttreatment and follow-up in their children’s conduct problems and adaptive functioning, as well as significant decreases in parenting stress. Parents in both treatment conditions also showed significant improvements in their parenting skills. There were no interactions between time and treatment format. Contrary to expectation, parents in group PCIT did not experience greater social support or treatment adherence. Conclusions Group PCIT was not inferior to individual PCIT and may be a valuable format to reach more families in need of services. Future work should explore the efficiency and sustainability of group PCIT in community settings. PMID:27018531

Motivational intervention to enhance post-detoxification 12-Step group affiliation: a randomized controlled trial.

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Vederhus, John-Kåre; Timko, Christine; Kristensen, Oistein; Hjemdahl, Bente; Clausen, Thomas

2014-05-01

To compare a motivational intervention (MI) focused on increasing involvement in 12-Step groups (TSGs; e.g. Alcoholics Anonymous) versus brief advice (BA) to attend TSGs. Patients were assigned randomly to either the MI or BA condition, and followed-up at 6 months after discharge. One hundred and forty substance use disorder (SUD) patients undergoing in-patient detoxification (detox) in Norway. The primary outcome was TSG affiliation measured with the Alcoholics Anonymous Affiliation Scale (AAAS), which combines meeting attendance and TSG involvement. Substance use and problem severity were also measured. At 6 months after treatment, compared with the BA group, the MI group had higher TSG affiliation [0.91 point higher AAAS score; 95% confidence interval (CI) = 0.04 to 1.78; P = 0.041]. The MI group reported 3.5 fewer days of alcohol use (2.1 versus 5.6 days; 95% CI = -6.5 to -0.6; P = 0.020) and 4.0 fewer days of drug use (3.8 versus 7.8 days; 95% CI = -7.5 to -0.4; P = 0.028); however, abstinence rates and severity scores did not differ between conditions. Analyses controlling for duration of in-patient treatment did not alter the results. A motivational intervention in an in-patient detox ward was more successful than brief advice in terms of patient engagement in 12-Step groups and reduced substance use at 6 months after discharge. There is a potential benefit of adding a maintenance-focused element to standard detox. © 2014 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

Does chess instruction improve mathematical problem-solving ability? Two experimental studies with an active control group.

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Sala, Giovanni; Gobet, Fernand

2017-12-01

It has been proposed that playing chess enables children to improve their ability in mathematics. These claims have been recently evaluated in a meta-analysis (Sala & Gobet, 2016, Educational Research Review, 18, 46-57), which indicated a significant effect in favor of the groups playing chess. However, the meta-analysis also showed that most of the reviewed studies used a poor experimental design (in particular, they lacked an active control group). We ran two experiments that used a three-group design including both an active and a passive control group, with a focus on mathematical ability. In the first experiment (N = 233), a group of third and fourth graders was taught chess for 25 hours and tested on mathematical problem-solving tasks. Participants also filled in a questionnaire assessing their meta-cognitive ability for mathematics problems. The group playing chess was compared to an active control group (playing checkers) and a passive control group. The three groups showed no statistically significant difference in mathematical problem-solving or metacognitive abilities in the posttest. The second experiment (N = 52) broadly used the same design, but the Oriental game of Go replaced checkers in the active control group. While the chess-treated group and the passive control group slightly outperformed the active control group with mathematical problem solving, the differences were not statistically significant. No differences were found with respect to metacognitive ability. These results suggest that the effects (if any) of chess instruction, when rigorously tested, are modest and that such interventions should not replace the traditional curriculum in mathematics.

Building Kindergartners' Number Sense: A Randomized Controlled Study.

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Jordan, Nancy C; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

2012-08-01

Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups ( n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures.

Assessment of two culturally competent diabetes education methods: individual versus individual plus group education in Canadian Portuguese adults with type 2 diabetes.

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Gucciardi, Enza; Demelo, Margaret; Lee, Ruth N; Grace, Sherry L

2007-04-01

To examine the impact of two culturally competent diabetes education methods, individual counselling and individual counselling in conjunction with group education, on nutrition adherence and glycemic control in Portuguese Canadian adults with type 2 diabetes over a three-month period. The Diabetes Education Centre is located in the urban multicultural city of Toronto, Ontario, Canada. We used a three-month randomized controlled trial design. Eligible Portuguese-speaking adults with type 2 diabetes were randomly assigned to receive either diabetes education counselling only (control group) or counselling in conjunction with group education (intervention group). Of the 61 patients who completed the study, 36 were in the counselling only and 25 in the counselling with group education intervention. We used a per-protocol analysis to examine the efficacy of the two educational approaches on nutrition adherence and glycemic control; paired t-tests to compare results within groups and analysis of covariance (ACOVA) to compare outcomes between groups adjusting for baseline measures. The Theory of Planned Behaviour was used to describe the behavioural mechanisms that influenced nutrition adherence. Attitudes, subjective norms, perceived behaviour control, and intentions towards nutrition adherence, self-reported nutrition adherence and glycemic control significantly improved in both groups, over the three-month study period. Yet, those receiving individual counselling with group education showed greater improvement in all measures with the exception of glycemic control, where no significant difference was found between the two groups at three months. Our study findings provide preliminary evidence that culturally competent group education in conjunction with individual counselling may be more efficacious in shaping eating behaviours than individual counselling alone for Canadian Portuguese adults with type 2 diabetes. However, larger longitudinal studies are needed to

Web-based screening and brief intervention for poly-drug use among teenagers: study protocol of a multicentre two-arm randomized controlled trial

Directory of Open Access Journals (Sweden)

Arnaud Nicolas

2012-09-01

Full Text Available Abstract Background Mid to late adolescence is characterised by a vulnerability to problematic substance use since the consumption of alcohol and illicit drugs is frequently initiated and increased in this life period. While the detrimental long- and short-term effects of problematic consumption patterns in adolescence pose a major public health concern, current prevention programs targeting alcohol- and other substance-using adolescents are scarce. The study described in this protocol will test the effectiveness of a web-based brief intervention aimed at reducing problematic alcohol use and promoting abstinence from illegal drugs in adolescents with risky substance use aged 16 to 18 years old in four EU-countries. Methods/design To determine the effectiveness of our web-BI, we apply a two-arm randomized controlled trial (RCT study design, with baseline assessment at study entry and a three month follow-up assessment. Adolescents aged 16 to 18 years from Belgium, the Czech Republic, Germany, and Sweden will be randomly assigned to either the fully electronically delivered brief intervention group (N = 400 or an assessment only control group (N = 400 depending on their screening for risky substance use (using the CRAFFT. Recruitment, informed consent, randomization, intervention and follow-up will be implemented online. Primary outcomes are reductions in frequency and quantity of use of alcohol and drugs other than alcohol over a 30 day period, as well as consumption per typical occasion. Secondary outcomes concern changes in substance use related cognitions including the constructs of the Theory of Planned Behaviour, implementation intentions, and stages of change. Moreover the study addresses a number of moderator variables, including age of first use, general psychopathology and quality of parent–child relationship. Discussion The trial is expected to contribute to the growing literature on theory- and web-based brief interventions

Group behavioral activation for patients with severe obesity and binge eating disorder: a randomized controlled trial.

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Alfonsson, Sven; Parling, Thomas; Ghaderi, Ata

2015-03-01

The aim of the present study was to assess whether behavioral activation (BA) is an efficacious treatment for decreasing eating disorder symptoms in patients with obesity and binge eating disorder (BED). Ninety-six patients with severe obesity and BED were randomized to either 10 sessions of group BA or wait-list control. The study was conducted at an obesity clinic in a regular hospital setting. The treatment improved some aspects of disordered eating and had a positive effect on depressive symptoms but there was no significant difference between the groups regarding binge eating and most other symptoms. Improved mood but lack of effect on binge eating suggests that dysfunctional eating (including BED) is maintained by other mechanisms than low activation and negative mood. However, future studies need to investigate whether effects of BA on binge eating might emerge later than at post-assessment, as in interpersonal psychotherapy for bulimia nervosa. © The Author(s) 2014.

Randomized controlled trial for assessment of Internet of Things system to guide intensive glucose control in diabetes outpatients: Nagoya Health Navigator Study protocol.

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Onoue, Takeshi; Goto, Motomitsu; Kobayashi, Tomoko; Tominaga, Takashi; Ando, Masahiko; Honda, Hiroyuki; Yoshida, Yasuko; Tosaki, Takahiro; Yokoi, Hisashi; Kato, Sawako; Maruyama, Shoichi; Arima, Hiroshi

2017-08-01

The Internet of Things (IoT) allows collecting vast amounts of health-relevant data such as daily activity, body weight (BW), and blood pressure (BP) automatically. The use of IoT devices to monitor diabetic patients has been studied, but could not evaluate IoT-dependent effects because health data were not measured in control groups. This multicenter, open-label, randomized, parallel group study will compare the impact of intensive health guidance using IoT and conventional medical guidance on glucose control. It will be conducted in outpatients with type 2 diabetes for a period of 6 months. IoT devices to measure amount of daily activity, BW, and BP will be provided to IoT group patients. Healthcare professionals (HCPs) will provide appropriate feedback according to the data. Non-IoT control, patients will be given measurement devices that do not have a feedback function. The primary outcome is glycated hemoglobin at 6 months. The study has already enrolled 101 patients, 50 in the IoT group and 51 in the non-IoT group, at the two participating outpatient clinics. The baseline characteristics of two groups did not differ, except for triglycerides. This will be the first randomized, controlled study to evaluate IoT-dependent effects of intensive feedback from HCPs. The results will validate a new method of health-data collection and provision of feedback suitable for diabetes support with increased effectiveness and low cost.

A two-input sliding-mode controller for a planar arm actuated by four pneumatic muscle groups.

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Lilly, John H; Quesada, Peter M

2004-09-01

Multiple-input sliding-mode techniques are applied to a planar arm actuated by four groups of pneumatic muscle (PM) actuators in opposing pair configuration. The control objective is end-effector tracking of a desired path in Cartesian space. The inputs to the system are commanded input pressure differentials for the two opposing PM groups. An existing model for the muscle is incorporated into the arm equations of motion to arrive at a two-input, two-output nonlinear model of the planar arm that is affine in the input and, therefore, suitable for sliding-mode techniques. Relationships between static input pressures are derived for suitable arm behavior in the absence of a control signal. Simulation studies are reported.

Effect of yoga on quality of life of CLBP patients: A randomized control study

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Tekur Padmini

2010-01-01

Full Text Available Context: In two of the earlier Randomized Control Trials on yoga for chronic lower back pain (CLBP, 12 to 16 weeks of intervention were found effective in reducing pain and disability. Aim: To study the efficacy of a residential short term intensive yoga program on quality of life in CLBP. Materials and Methods: About 80 patients with CLBP (females 37 registered for a week long treatment at SVYASA Holistic Health Centre in Bengaluru, India. They were randomized into two groups (40 each. The yoga group practiced a specific module for CLBP comprising of asanas (physical postures, pranayama (breathing practices, meditation and lectures on yoga philosophy. The control group practiced physical therapy exercises for back pain. Perceived stress scale (PSS was used to measure baseline stress levels. Outcome measures were WHOQOL Bref for quality of life and straight leg raising test (SLR using a Goniometer. Results: There were significant negative correlations (Pearson′s, P<0.005, r>0.30 between baseline PSS with all four domains and the total score of WHOQOLBref. All the four domains′ WHOQOLBref improved in the yoga group (repeated measures ANOVA P=0.001 with significant groupFNx01time interaction (P<0.05 and differences between groups (P<0.01. SLR increased in both groups (P=0.001 with higher increase in yoga (31.1 % right, 28.4 % left than control (18.7% right, 21.5 % left group with significant groupFNx01time interaction (SLR right leg P=0.044. Conclusion: In CLBP, a negative correlation exists between stress and quality of life. Yoga increases quality of life and spinal flexibility better than physical therapy exercises.

Laxation of critically ill patients with lactulose or polyethylene glycol : a two-center randomized, double-blind, placebo-controlled trial

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van der Spoel, Johan I; Oudemans-van Straaten, Heleen M; Kuiper, Michael A; van Roon, Eric N; Zandstra, Durk F; van der Voort, Peter H J

2007-01-01

OBJECTIVE: To study whether lactulose or polyethylene glycol is effective to promote defecation in critically ill patients, whether either of the two is superior, and whether the use of enteral laxatives is related to clinical outcome. DESIGN: Double-blind, placebo-controlled, randomized study.

Effect of two contrasting interventions on upper limb chronic pain and disability: a randomized controlled trial.

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Sundstrup, Emil; Jakobsen, Markus D; Andersen, Christoffer H; Jay, Kenneth; Persson, Roger; Aagaard, Per; Andersen, Lars L

2014-01-01

Chronic pain and disability of the arm, shoulder, and hand severely affect labor market participation. Ergonomic training and education is the default strategy to reduce physical exposure and thereby prevent aggravation of pain. An alternative strategy could be to increase physical capacity of the worker by physical conditioning. To investigate the effect of 2 contrasting interventions, conventional ergonomic training (usual care) versus resistance training, on pain and disability in individuals with upper limb chronic pain exposed to highly repetitive and forceful manual work. Examiner-blinded, parallel-group randomized controlled trial with allocation concealment. Slaughterhouses located in Denmark, Europe. Sixty-six adults with chronic pain in the shoulder, elbow/forearm, or hand/wrist and work disability were randomly allocated to 10 weeks of specific resistance training for the shoulder, arm, and hand muscles for 3 x 10 minutes per week, or ergonomic training and education (usual care control group). Pain intensity (average of shoulder, arm, and hand, scale 0 - 10) was the primary outcome, and disability (Work module of DASH questionnaire) as well as isometric shoulder and wrist muscle strength were secondary outcomes. Pain intensity, disability, and muscle strength improved more following resistance training than usual care (P effect size of 0.91 (Cohen's d). Blinding of participants is not possible in behavioral interventions. However, at baseline outcome expectations of the 2 interventions were similar. Resistance training at the workplace results in clinical relevant improvements in pain, disability, and muscle strength in adults with upper limb chronic pain exposed to highly repetitive and forceful manual work. NCT01671267.

Effect of Pentoxifylline on Microalbuminuria in Diabetic Patients: A Randomized Controlled Trial

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Shahrzad Shahidi

2015-01-01

Full Text Available Background. Pentoxifylline is a nonspecific phosphodiesterase inhibitor with anti-inflammatory properties. Human studies have proved its antiproteinuric effect in patients with glomerular diseases, but this study was designed to assess the effects of add-on pentoxifylline to available treatment on reduction of microalbuminuria in diabetic patients without glomerular diseases. Methods. In a double-blind placebo-controlled, randomized study we evaluated the influence of pentoxifylline on microalbuminuria in type 2 diabetic patients. 40 diabetic patients with estimated glomerular filtration rate (eGFR of more than 60 mL/min/1.73 m2 in eight weeks and microalbuminuria were randomized to two groups which will receive pentoxifylline 1200 mg/day or placebo added to regular medications for 6 months. albuminuria; eGFR was evaluated at three- and six-month follow-up period. Results. Baseline characteristics were similar between the two groups. At six months, the mean estimated GFR and albuminuria were not different between two groups at 3- and 6-month follow-up. Trend of albumin to creatinine ratio, systolic and diastolic blood pressure, and eGFR in both groups were decreased, but no significant differences were noted between two groups (P value > 0.05. Conclusion. Pentoxifylline has not a significant additive antimicroalbuminuric effect compared with placebo in patients with type 2 diabetes with early stage of kidney disease; however, further clinical investigations are necessary to be done.

Moxibustion for breech version: a randomized controlled trial.

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Guittier, Marie-Julia; Pichon, Michelle; Dong, Hongguang; Irion, Olivier; Boulvain, Michel

2009-11-01

To estimate the efficacy of moxibustion between 34 and 38 weeks of gestation to facilitate the cephalic version of fetuses in breech presentation and the acceptability of this method by women. We conducted a randomized controlled trial in a Swiss university hospital maternity unit. We proposed to stimulate the acupoint BL 67 by moxibustion daily for 2 weeks for 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation. We did the intervention three times weekly in the hospital and a teaching session and information leaflet on the technique for additional daily therapy at home. The control group received expectant management care. The availability of external cephalic version was maintained for both groups. The main outcome measure was the comparison of the proportion of women with cephalic presentation at delivery. Baseline characteristics were similar between groups, except more nulliparous women were randomized to moxibustion. The percentage of versions was similar between groups: 18% in the moxibustion group compared with 16% in the control group (relative risk 1.12, 95% confidence interval 0.62 to 2.03). Adjustment for the imbalance in parity did not change these results. The frequency of cesarean delivery was similar (64% compared with 58% in the moxibustion group and the control group, respectively). Acceptability of the intervention and women's perceptions of moxibustion were favorable. We observed no beneficial effect of moxibustion to facilitate the cephalic version of fetuses in breech presentation. Despite this lack of proven effectiveness, women had positive opinions on the intervention. ClinicalTrials.gov, www.clinicaltrials.gov,NCT00890474. I.

Mask ventilation with two different face masks in the delivery room for preterm infants: a randomized controlled trial.

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Cheung, D; Mian, Q; Cheung, P-Y; O'Reilly, M; Aziz, K; van Os, S; Pichler, G; Schmölzer, G M

2015-07-01

If an infant fails to initiate spontaneous breathing after birth, international guidelines recommend a positive pressure ventilation (PPV). However, PPV by face mask is frequently inadequate because of leak between the face and mask. Despite a variety of available face masks, none have been prospectively compared in a randomized fashion. We aimed to evaluate and compare leak between two commercially available round face masks (Fisher & Paykel (F&P) and Laerdal) in preterm infants mask PPV in the delivery room routinely had a flow sensor placed between the mask and T-piece resuscitator. Infants were randomly assigned to receive PPV with either a F&P or Laerdal face mask. All resuscitators were trained in the use of both face masks. We compared mask leak, airway pressures, tidal volume and ventilation rate between the two groups. Fifty-six preterm infants (n=28 in each group) were enrolled; mean±s.d. gestational age 28±3 weeks; birth weight 1210±448 g; and 30 (52%) were male. Apgar scores at 1 and 5 min were 5±3 and 7±2, respectively. Infants randomized to the F&P face mask and Laerdal face mask had similar mask leak (30 (25-38) versus 35 (24-46)%, median (interquartile range), respectively, P=0.40) and tidal volume (7.1 (4.9-8.9) versus 6.6 (5.2-8.9) ml kg(-1), P=0.69) during PPV. There were no significant differences in ventilation rate, inflation time or airway pressures between groups. The use of either face mask during PPV in the delivery room yields similar mask leak in preterm infants <33 weeks gestational age.

Local drinking water filters reduce diarrheal disease in Cambodia: a randomized, controlled trial of the ceramic water purifier.

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Brown, Joe; Sobsey, Mark D; Loomis, Dana

2008-09-01

A randomized, controlled intervention trial of two household-scale drinking water filters was conducted in a rural village in Cambodia. After collecting four weeks of baseline data on household water quality, diarrheal disease, and other data related to water use and handling practices, households were randomly assigned to one of three groups of 60 households: those receiving a ceramic water purifier (CWP), those receiving a second filter employing an iron-rich ceramic (CWP-Fe), and a control group receiving no intervention. Households were followed for 18 weeks post-baseline with biweekly follow-up. Households using either filter reported significantly less diarrheal disease during the study compared with a control group of households without filters as indicated by longitudinal prevalence ratios CWP: 0.51 (95% confidence interval [CI]: 0.41-0.63); CWP-Fe: 0.58 (95% CI: 0.47-0.71), an effect that was observed in all age groups and both sexes after controlling for clustering within households and within individuals over time.

The effectiveness of a Housing First adaptation for ethnic minority groups: findings of a pragmatic randomized controlled trial

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Vicky Stergiopoulos

2016-10-01

Full Text Available Abstract Background Little is known about the effectiveness of Housing First (HF among ethnic minority groups, despite its growing popularity for homeless adults experiencing mental illness. This randomized controlled trial tests the effectiveness of a HF program using rent supplements and intensive case management, enhanced by anti-racism and anti-oppression practices for homeless adults with mental illness from diverse ethnic minority backgrounds. Methods This unblinded pragmatic field trial was carried out in community settings in Toronto, Canada. Participants were 237 adults from ethnic minority groups experiencing mental illness and homelessness, who met study criteria for moderate needs for mental health services. Participants were randomized to either adapted HF (n = 135 or usual care (n = 102 and followed every 3 months for 24 months. The primary study outcome was housing stability; secondary outcomes included physical and mental health, social functioning, quality of life, arrests and health service use. Intention to treat statistical analyses examined the effectiveness of the intervention compared to usual care. Results During the 24-month study period, HF participants were stably housed a significantly greater proportion of time compared to usual care participants, 75 % (95 % CI 70 to 81 vs. 41 % (95 % CI 35 to 48, respectively, for a difference of 34 %, 95 % CI 25 to 43. HF also led to improvements in community integration over the course of the study: the change in the mean difference between treatment groups from baseline to 24-months was significantly greater among HF participants compared to those in usual care (change in mean difference = 2.2, 95 % CI 0.06 to 4.3. Baseline diagnosis of psychosis was associated with reduced likelihood of being housed ≥ 50 % of the study period (OR = 0.37, 95 % CI 0.18 to 0.72. Conclusion Housing First enhanced with anti-racism and anti-oppression practices can

Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue: a multicenter, nonblinded, randomized controlled trial.

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Kim, Jung-Eun; Seo, Byung-Kwan; Choi, Jin-Bong; Kim, Hyeong-Jun; Kim, Tae-Hun; Lee, Min-Hee; Kang, Kyung-Won; Kim, Joo-Hee; Shin, Kyung-Min; Lee, Seunghoon; Jung, So-Young; Kim, Ae-Ran; Shin, Mi-Suk; Jung, Hee-Jung; Park, Hyo-Ju; Kim, Sung-Phil; Baek, Yong-Hyeon; Hong, Kwon-Eui; Choi, Sun-Mi

2015-07-26

The causes of chronic fatigue syndrome (CFS) and idiopathic chronic fatigue (ICF) are not clearly known, and there are no definitive treatments for them. Therefore, patients with CFS and ICF are interested in Oriental medicine or complementary and alternative medicine. For this reason, the effectiveness of complementary and alternative treatments should be verified. We investigated the effectiveness of two forms of acupuncture added to usual care for CFS and ICF compared to usual care alone. A three-arm parallel, non-blinded, randomized controlled trial was performed in four hospitals. We divided 150 participants into treatment and control groups at the same ratio. The treatment groups (Group A, body acupuncture; Group B, Sa-am acupuncture) received 10 sessions for 4 weeks. The control group (Group C) continued usual care alone. The primary outcome was the Fatigue Severity Scale (FSS) at 5 weeks after randomization. Secondary outcomes were the FSS at 13 weeks and a short form of the Stress Response Inventory (SRI), the Beck Depression Inventory (BDI), the Numeric Rating Scale (NRS), and the EuroQol-5 Dimension (EQ-5D) at 5 and 13 weeks. Group A showed significantly lower FSS scores than Group C at 5 weeks (P = 0.023). SRI scores were significantly lower in the treatment groups than in the control group at 5 (Group A, P = 0.032; B, P fatigue in CFS and ICF patients. Clinical Research Information Service (CRIS) KCT0000508; Registered on 12 August 2012.

Analysis of Postural Control During Quiet Standing in a Population with Diabetic Peripheral Neuropathy Undergoing Moderate Intensity Aerobic Exercise Training: A Single Blind, Randomized Controlled Trial.

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Dixit, Snehil; Maiya, Arun; Shastry, Barkur A; Guddattu, Vasudev

2016-07-01

The aim of this study was to investigate the effect of 8 wks of moderate-intensity aerobic exercise on postural control during quiet standing in type 2 diabetic peripheral neuropathy. Individuals were included in the study if they had type 2 diabetes with clinical neuropathy, defined by a minimum score of 7 on the Michigan Diabetic Neuropathy Score, following which the patients were randomly assigned to an 8-wk program by computer-generated random number tables to study or control group. Repeated-measures analysis of variance was used for data analysis (P < 0.05 was considered significant). After final randomization, there were 36 patients in the study group and 45 in the control group. On comparison of results for control and study groups using repeated-measures analysis of variance only in the eyes closed on foam condition was there was a significant difference between the two groups for sway velocity along the x-axis (df1, df2 = 1, 18, F = 3.86, P = 0.04) and mediolateral displacement (df1, df2 = 1, 18, F = 4.04, P = 0.03). Aerobic exercise training could exert a therapeutic effect on center of pressure movement only along the x-axis in the eyes closed condition on foam surface during quiet standing.

Local endometrial scratching under ultrasound-guidance after failed intrauterine insemination and cycle outcome: A randomized controlled trial

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Badeea S. Soliman

2017-03-01

Full Text Available Background: Interaction between the embryo and endometrium plus endometrial receptivity is considered as two strong issues affecting the implantation outcome. Purpose: To investigate the effect of local endometrial scratching on pregnancy rate after failed previous intra uterine insemination. Study design: A prospective, randomized, control trial. Setting: At Cytogenetic and Endoscopy Unit, Zagazig University Hospital. Patients and methods: A total of 226 women either with unexplained or with mild male factor infertility were divided randomly into approximately two groups: in study group, 114 women and in control group, 112 women. For both groups, folliculometry was started at cycle day 7 additionally and at the same setting; endometrial scratching was done only for the study group. Outcome results: Biochemical and clinical pregnancy rates. Results: The biochemical and clinical pregnancy rates were significantly higher in the endometrial scratching group compared to the control group [27/106 (25.5% vs. 15/106 (14.1% p = 0.03 and 24/106 (22.6% vs. 12/106 (11.3%; p = 0.02] respectively. Also, ongoing pregnancy rate was statistically significantly different between both groups [22/106 (20.7% vs. 11/106 (10.4%; p = 0.03]. Conclusion: Endometrial scratching is useful in increasing pregnancy rates after failed previous intra uterine insemination trials when it is performed in the mid proliferative phase.

A comparison of two short education programs for improving low back pain-related disability in the elderly: a cluster randomized controlled trial.

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Kovacs, Francisco; Abraira, Víctor; Santos, Severo; Díaz, Elena; Gestoso, Mario; Muriel, Alfonso; Gil del Real, María Teresa; Mufraggi, Nicole; Noguera, Juan; Zamora, Javier

2007-05-01

Cluster randomized clinical trial. To assess the effectiveness of 2 minimal education programs for improving low back pain (LBP)-related disability in the elderly. No education program has shown effectiveness on low back pain (LBP)-related disability in the elderly. A total of 129 nursing homes (6389 residents) in northern Spain were invited to participate in the study. The actual participants were 12 nursing homes randomly assigned to 3 groups and 661 subjects. An independent physician gave a 20-minute talk with slide projections summarizing the content of the Back Book (active management group), the Back Guide (postural hygiene group), and a pamphlet on cardiovascular health (controls). Disability was measured with the Roland-Morris questionnaire (RMQ). Blind assessments were performed before the intervention, and 30 and 180 days later. The effect of the intervention on disability was estimated by generalized mixed linear random effects models. Mean age of participants ranged between 79.9 and 81.2 years. Disability improved in all groups, but at the 30-day assessment the postural education group showed an additional improvement of 1.1 (95% confidence interval, 0.2-1.9), RMQ points and at the 180-day assessment the active education group an additional improvement of 2.0 (95% confidence interval, 0.6-3.4). In the subset of subjects with LBP when entering the study, postural education had no advantages over controls, while an additional improvement of 3.0 (95% confidence interval, 1.5- 4.5) RMQ points at the 180-day assessment was observed in the active education group. In institutionalized elderly, the handing out of the Back Book supported by a 20-minute group talk improves disability 6 months later, and is even more effective in those subjects with LBP.

Fundamental movement skills in preschoolers: a randomized controlled trial targeting object control proficiency.

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Donath, L; Faude, O; Hagmann, S; Roth, R; Zahner, L

2015-11-01

Adequately developed fundamental movement skills, particularly object control dimensions, are considered essential to learn more complex movement patterns and to increase the likelihood to successfully participate in organized and non-organized sports during later years. Thus, the present randomized controlled trial aimed at improving object control dimensions at an early state in a kindergarten setting. Catching, throwing, kicking, rolling and stationary dribbling were assessed via gross motor development 2 (TGMD-2) testing in 41 normally developed preschoolers. On a cluster-randomized basis [strata: age, sex and body mass index (BMI)], three kindergartens were randomly assigned to an intervention group (n = 22, INT, age: 4.6 ± 1.0 years; BMI: 16.2 ± 1.1 kg/m(2) ) and three to a control group (n = 19, CON: age: 4.5 ± 1.2 years; BMI: 16.8 ± 1.2 kg/m(2) ). Twelve structured training sessions were given within 6 weeks (12 sessions). The total training volume was 330 min. Moderate time × group interaction were observed for the total sum score (Δ+22%, P = 0.05) and dribbling (Δ+41%, P = 0.002). Adjusting for baseline differences analyses of covariance did not affect these results. Interestingly, likely to most likely practically worthwhile effects were detected for the total sum score, catching and dribbling. Object control dimensions such as dribbling and catching that apparently rely on rhythmical movement patterns and anticipatory eye-hand coordination seem to benefit from short-term object control training. These skills are considered important for successful team-sport participation and appropriate sportive motor development. © 2015 John Wiley & Sons Ltd.

Child oral health-related quality of life and early childhood caries: a non-inferiority randomized control trial.

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Arrow, P; Klobas, E

2016-06-01

The aim of this study was to compare changes in child oral health-related quality of life (COHRQoL) after treatment for early childhood caries (ECC) using two alternative treatment approaches. A randomized control trial with random allocation of parent/child dyads with ECC to test (minimum intervention) or control (standard care). Participating parents completed the Early Childhood Oral Health Impact Scale (ECOHIS) at baseline and follow-up. Changes in ECOHIS scores and extent of COHRQoL impacts between and within groups were tested using the chi-squared statistic for groups, Wilcoxon's rank-sum test, and matched-pairs signed-rank test. Two hundred and fifty-four children were randomized (test = 127; control = 127). At baseline, mean ECOHIS score 11.1, sd 8.2; mean age = 3.8 years, sd 0.90; mean dmft = 4.9, sd 4.0; and 59% male. After a mean interval of 11.4 months, 210 children were followed-up and returned a completed questionnaire (test = 111; control = 99). There was no significant difference in COHRQoL changes between test and control. For all the children combined, there were significantly fewer impacts at follow-up in the child and family domains and the total ECOHIS, Wilcoxon signed-rank test, p test and control in the extent of the improvement. © 2016 Australian Dental Association.

Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

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Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

2017-06-01

The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

The feasibility of progressive resistance training in women with polycystic ovary syndrome: a pilot randomized controlled trial.

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Vizza, Lisa; Smith, Caroline A; Swaraj, Soji; Agho, Kingsley; Cheema, Birinder S

2016-01-01

To evaluate the feasibility of executing a randomized controlled trial of progressive resistance training (PRT) in women with polycystic ovary syndrome (PCOS). Women with PCOS were randomized to an experimental (PRT) group or a no-exercise (usual care) control group. The PRT group was prescribed two supervised and two unsupervised (home-based) training sessions per week for 12 weeks. Feasibility outcomes included recruitment and attrition, adherence, adverse events, and completion of assessments. Secondary outcomes, collected pre and post intervention, included a range of pertinent physiological, functional and psychological measures. Fifteen participants were randomised into the PRT group (n = 8) or control group (n = 7); five women (n = 2 in PRT group and n = 3 in control group) withdrew from the study. The most successful recruitment sources were Facebook (40 %) and online advertisement (27 %), while least successful methods were referrals by clinicians, colleagues and flyers. In the PRT group, attendance to supervised sessions was higher (95 %; standard deviation ±6 %) compared to unsupervised sessions (51 %; standard deviation ±28 %). No adverse events were attributed to PRT. Change in menstrual cycle status was not significantly different between groups over time (p = 0.503). However, the PRT group significantly increased body weight (p = 0.01), BMI (p = 0.04), lean mass (p = 0.01), fat-free mass (p = 0.005) and lower body strength (p = 0.03), while reducing waist circumference (p = 0.03) and HbA1c (p = 0.033) versus the control group. The PRT group also significantly improved across several domains of disease-specific and general health-related quality of life, depression, anxiety and exercise self-efficacy. A randomized controlled trial of PRT in PCOS would be feasible, and this mode of exercise may elicit a therapeutic effect on clinically important outcomes in this cohort. The success of a large

Building Kindergartners’ Number Sense: A Randomized Controlled Study

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Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

2015-01-01

Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups (n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures. PMID:25866417

Self-tracking of physical activity in people with type 2 diabetes : a randomized controlled trial

NARCIS (Netherlands)

Kooiman, Thea; de Groot, Martijn; Hoogenberg, Klaas; Krijnen, Wim P; van der Schans, Cees P; Kooy, Adriaan

2018-01-01

The purpose of this study was to determine the efficacy of an online self-tracking program on physical activity, glycated hemoglobin, and other health measures in patients with type 2 diabetes. Seventy-two patients with type 2 diabetes were randomly assigned to an intervention or control group. All

Short-term intensive psychodynamic group therapy versus cognitive-behavioral group therapy in day treatment of anxiety disorders and comorbid depressive or personality disorders: study protocol for a randomized controlled trial.

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Suszek, Hubert; Holas, Paweł; Wyrzykowski, Tomasz; Lorentzen, Steinar; Kokoszka, Andrzej

2015-07-29

Psychodynamic and cognitive-behavioral group therapies are frequently applied in day hospitals for the treatment of anxiety disorders and comorbid depressive or personality disorders in Poland and other Eastern European countries. Yet there is not enough evidence as to their effectiveness in this environment; this study addresses this gap. The aim of the study is to determine the effectiveness of these two kinds of day treatment care consisting of intensive, short-term group psychodynamic and cognitive-behavioral therapy, for patients with anxiety disorders and/or comorbid depressive or personality disorders. Our objectives are to: 1) show the effectiveness of each treatment in a day-care setting relative to the wait-list control group; 2) demonstrate the relative short- and long-term effectiveness of the two active treatments; 3) carry out a preliminary examination of the predictors and moderators of treatment response; 4) carry out a preliminary examination of the mediators of therapeutic change; and 5) compare the impact of both methods of treatment on the outcome of the measures used in this study. In this randomized controlled trial, a total of 199 patients with anxiety disorders and comorbid depressive and/or personality disorders will be assigned to one of three conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; or 3) wait-list control group. The therapy will last 12 weeks. Both treatments will be manualized (the manuals will address comorbidity). Primary outcome measures will include self-reported symptoms of anxiety, observer-rated symptoms of anxiety, global improvement, and recovery rate. Secondary outcome measures will include the number of pathological personality traits, depression, self-esteem, defense mechanisms, beliefs about self and others, interpersonal problems, object relations, parental bonding, meta-cognition, and quality of life. Measures will be taken at baseline, post-treatment, and at six months following

A randomized controlled trial of a brief versus standard group parenting program for toddler aggression.

Science.gov (United States)

Tully, Lucy A; Hunt, Caroline

2017-05-01

Physical aggression (PA) in the toddler years is common and developmentally normal, however, longitudinal research shows that frequent PA is highly stable and associated with long-term negative outcomes. Significant research has demonstrated the efficacy of parenting interventions for reducing externalizing behavior in children yet their typical length may overburden families, leading to low participation rates and high attrition rates. To increase the reach of parenting interventions and impact on the prevalence of externalizing behavior problems, brief interventions are needed. This RCT compared a standard (8 session) group Triple P to a brief (3 session) discussion group and a waitlist control for reducing toddler PA, dysfunctional parenting and related aspects of parent functioning. Sixty-nine self-referred families of toddlers with PA were randomized to the respective conditions. At post-assessment, families in the standard intervention had significantly lower levels of observed child aversive behavior, mother reports of PA and dysfunctional parenting, and higher levels of mother- and partner-rated behavioral self-efficacy than the waitlist control. Families in the standard intervention also had significantly lower levels mother-rated dysfunctional parenting than the brief intervention, and the brief intervention had significantly lower levels of mother-rated dysfunctional parenting than waitlist. There were no significant group differences at post-assessment for measures of parental negative affect or satisfaction with the partner relationship. By 6 month follow-up, families in the brief and standard intervention did not differ significantly on any measure. The implications of the findings to delivery of brief parenting interventions are discussed. Aggr. Behav. 43:291-303, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Community-based group exercise for persons with Parkinson disease: a randomized controlled trial.

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Combs, Stephanie A; Diehl, M Dyer; Chrzastowski, Casey; Didrick, Nora; McCoin, Brittany; Mox, Nicholas; Staples, William H; Wayman, Jessica

2013-01-01

The purpose of this study was to compare group boxing training to traditional group exercise on function and quality of life in persons with Parkinson disease (PD). A convenience sample of adults with PD (n = 31) were randomly assigned to boxing training or traditional exercise for 24-36 sessions, each lasting 90 minutes, over 12 weeks. Boxing training included: stretching, boxing (e.g. lateral foot work, punching bags), resistance exercises, and aerobic training. Traditional exercise included: stretching, resistance exercises, aerobic training, and balance activities. Participants were tested before and after completion of training on balance, balance confidence, mobility, gait velocity, gait endurance, and quality of life. The traditional exercise group demonstrated significantly greater gains in balance confidence than the boxing group (p effect size for the gait endurance (d = 0.65). Both groups demonstrated significant improvements with the balance, mobility, and quality of life with large within-group effect sizes (d ≥ 0.80). While groups significantly differed in balance confidence after training, both groups demonstrated improvements in most outcome measures. Supporting options for long-term community-based group exercise for persons with PD will be an important future consideration for rehabilitation professionals.

Tensor renormalization group with randomized singular value decomposition

Science.gov (United States)

Morita, Satoshi; Igarashi, Ryo; Zhao, Hui-Hai; Kawashima, Naoki

2018-03-01

An algorithm of the tensor renormalization group is proposed based on a randomized algorithm for singular value decomposition. Our algorithm is applicable to a broad range of two-dimensional classical models. In the case of a square lattice, its computational complexity and memory usage are proportional to the fifth and the third power of the bond dimension, respectively, whereas those of the conventional implementation are of the sixth and the fourth power. The oversampling parameter larger than the bond dimension is sufficient to reproduce the same result as full singular value decomposition even at the critical point of the two-dimensional Ising model.

Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial.

Science.gov (United States)

Faurholt-Jepsen, M; Frost, M; Ritz, C; Christensen, E M; Jacoby, A S; Mikkelsen, R L; Knorr, U; Bardram, J E; Vinberg, M; Kessing, L V

2015-10-01

The number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence. Nevertheless, the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder. A total of 78 patients with bipolar disorder according to ICD-10 criteria, aged 18-60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups. Intention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms. There was a tendency towards more sustained depressive symptoms in the intervention group (B = 2.02, 95% confidence interval -0.13 to 4.17, p = 0.066). Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group. These results highlight that electronic self-monitoring, although intuitive and appealing, needs critical consideration and further clarification before it is implemented as a clinical tool.

Effects of oral vitamin E on treatment of atopic dermatitis: A randomized controlled trial.

Science.gov (United States)

Jaffary, Fariba; Faghihi, Gita; Mokhtarian, Arghavan; Hosseini, Sayed Mohsen

2015-11-01

The pathogenesis of atopic dermatitis (AD) remains to be determined; recently a possible change in the immune system with production of immunoglobulins is proposed. As vitamin E is a potent antioxidant, with the ability to decrease the serum levels of immunoglobulin E (IgE) in atopic patients, we aimed to evaluate the effect of oral vitamin E on treatment of AD. This randomized, double-blind, placebo-controlled trial comprised seventy participants with mild-to-moderate AD, based on the Hanifin and Rajka diagnostic criteria. The patients were randomly selected from teaching skin clinics in Isfahan, Iran. They were randomly assigned to two groups of equal number, receiving vitamin E (400 IU/day) and placebo for four 4 months. Each month, the extent, severity, and subjective symptoms including itch and sleeplessness were measured by SCORAD index. Three months after the end of intervention, the recurrence rate was assessed. The improvement in all symptoms, except sleeplessness, was significantly higher in the group receiving vitamin E than in controls (-1.5 vs. 0.218 in itching, -10.85 vs. -3.54 in extent of lesion, and -11.12 vs. -3.89 in SCORAD index, respectively, P vitamin E compared to the placebo group was 1.17, without significant differences between the two groups (P > 0.05). This study suggests that vitamin E can improve the symptoms and the quality of life in patients with AD. As vitamin E has no side effects with a dosage of 400 IU/day, it can be recommended for the treatment of AD.

Laparoscopic Surgical Treatment of Severe Obesity Combined with Gastroesophageal Reflux Disease: A Pilot Randomized Two-Arm Controlled Clinical Study

Science.gov (United States)

Ospanov, Oral B.; Orekeshova, Akzhunis M.; Fursov, Roman A.; Yelemesov, Aset A.

2016-01-01

Obesity and gastroesophageal reflux disease (GERD) are serious medical, social, and economic problems of modern society. A pilot randomized two-arm controlled clinical study was conducted to compare laparoscopic plication of the greater gastric curvature combined with Nissen fundoplication (LFN+LGP) versus only Nissen fundoplication (LFN). The…

Effects of park walks and relaxation exercises during lunch breaks on recovery from job stress : Two randomized controlled trials

NARCIS (Netherlands)

de Bloom, Jessica; Sianoja, Marjaana; Korpela, Kalevi; Tuomisto, Martti; Lilja, Ansa; Geurts, Sabine; Kinnunen, Ulla

Lunch breaks constitute the longest within-workday rest period, but it is unclear how they affect recovery from job stress. We conducted two randomized controlled trials with 153 Finnish knowledge workers who engaged for 15 min daily in prescribed lunch break activities for ten consecutive working

Design and rationale of the medical students learning weight management counseling skills (MSWeight) group randomized controlled trial.

Science.gov (United States)

Ockene, Judith K; Ashe, Karen M; Hayes, Rashelle B; Churchill, Linda C; Crawford, Sybil L; Geller, Alan C; Jolicoeur, Denise; Olendzki, Barbara C; Basco, Maria Theresa; Pendharkar, Jyothi A; Ferguson, Kristi J; Guck, Thomas P; Margo, Katherine L; Okuliar, Catherine A; Shaw, Monica A; Soleymani, Taraneh; Stadler, Diane D; Warrier, Sarita S; Pbert, Lori

2018-01-01

Physicians have an important role addressing the obesity epidemic. Lack of adequate teaching to provide weight management counseling (WMC) is cited as a reason for limited treatment. National guidelines have not been translated into an evidence-supported, competency-based curriculum in medical schools. Weight Management Counseling in Medical Schools: A Randomized Controlled Trial (MSWeight) is designed to determine if a multi-modal theoretically-guided WMC educational intervention improves observed counseling skills and secondarily improve perceived skills and self-efficacy among medical students compared to traditional education (TE). Eight U.S. medical schools were pair-matched and randomized in a group randomized controlled trial to evaluate whether a multi-modal education (MME) intervention compared to traditional education (TE) improves observed WMC skills. The MME intervention includes innovative components in years 1-3: a structured web-course; a role play exercise, WebPatientEncounter, and an enhanced outpatient internal medicine or family medicine clerkship. This evidence-supported curriculum uses the 5As framework to guide treatment and incorporates patient-centered counseling to engage the patient. The primary outcome is a comparison of scores on an Objective Structured Clinical Examination (OSCE) WMC case among third year medical students. The secondary outcome compares changes in scores of medical students from their first to third year on an assessment of perceived WMC skills and self-efficacy. MSWeight is the first RCT in medical schools to evaluate whether interventions integrated into the curriculum improve medical students' WMC skills. If this educational approach for teaching WMC is effective, feasible and acceptable it can affect how medical schools integrate WMC teaching into their curriculum. Copyright © 2017 Elsevier Inc. All rights reserved.

Effects of joint mobilization on chronic ankle instability: a randomized controlled trial.

Science.gov (United States)

Cruz-Díaz, David; Lomas Vega, Rafael; Osuna-Pérez, Maria Catalina; Hita-Contreras, Fidel; Martínez-Amat, Antonio

2015-01-01

To evaluate the effects of joint mobilization, in which movement is applied to the ankle's dorsiflexion range of motion, on dynamic postural control and on the self-reported instability of patients with chronic ankle instability (CAI). A double-blind, placebo-controlled, randomized trial with repeated measures and a follow-up period. Ninety patients with a history of recurrent ankle sprain, self-reported instability, and a limited dorsiflexion range of motion, were randomly assigned to either the intervention group (Joint Mobilizations, 3 weeks, two sessions per week) the placebo group (Sham Mobilizations, same duration as joint mobilization) or the control group, with a 6 months follow-up. Dorsiflexion Range of Motion (DFROM), Star Excursion Balance Test (SEBT) and CAI Tool (CAIT) were outcome measures. A separate 3 × 4 mixed model analysis of variance was performed to examine the effect of treatment conditions and time, and intention-to-treat (ITT) analysis was applied to evaluate the effect of the independent variable. The application of joint mobilization resulted in better scores of DFROM, CAIT, and SEBTs in the intervention group when compared with the placebo or the control groups (p ankle DFROM, postural control, and self-reported instability. These results suggest that joint mobilization could be applied to patients with recurrent ankle sprain to help restore their functional stability. Implications for Rehabilitation Functional instability is a very common sequela in patients with CAI, resulting in reduced quality of living due to the limitations it imposes on daily life activities. The mobilization with movement technique presented by Mulligan, and based on the joint mobilization accompanied by active movement, appears as a valuable tool to be employed by physical therapists to restore ankle function after a recurrent ankle sprain history. ROM restriction, subjective feeling of instability and dynamic postural control are benefiting from the joint

The role of telenursing in the management of Diabetes Type 1: A randomized controlled trial.

Science.gov (United States)

Kotsani, Konstantia; Antonopoulou, Vasiliki; Kountouri, Aikaterini; Grammatiki, Maria; Rapti, Eleni; Karras, Spyridon; Trakatelli, Christina; Tsaklis, Panagiotis; Kazakos, Kiriakos; Kotsa, Kalliopi

2018-04-01

Diabetes Mellitus type 1 (T1DM) is a chronic disease that requires patients' self-monitoring and self-management to achieve glucose targets and prevent complications. Telenursing implicates technology in the interaction of a specialized nurse with patients with chronic diseases in order to provide personalized care and support. To evaluate the effect of telenursing on T1DM patients' compliance with glucose self-monitoring and glycemic control. Randomized controlled study. Outpatient Department of Diabetes, Endocrinology and Metabolism of a University Hospital in Northern Greece. Ninety-four T1DM patients were recruited and randomized in two groups by a random number generator. The intervention group (N = 48) was provided with telenursing services. A specialized nurse made a weekly contact via telephone motivating patients to frequently measure blood glucose and adopt a healthy lifestyle. The control group (N = 46) received standard diabetes advice and care in the clinic. The primary outcome was the effect of the intervention in glucose control and glucose variability. The secondary outcome was the effect on frequency of self-monitoring. SPSS 20.0 was used for data analysis. The two groups did not differ in age, sex, physical activity or initial HbA1c. In the intervention group, blood glucose significantly decreased at the end of the study in all predefined measurements, compared to control group: morning (93.18 ± 13.30 mg/dl vs. 105.17 ± 13.74 mg/dl, p < 0.005), pre-prandial (114.76 ± 9.54 mg/dl vs. 120.84 ± 4.05 mg/dl, p < 0.005), post-prandial (193.35 ± 25.36 mg/dl vs. 207.84 ± 18.80 mg/dl, p < 0.005), and HbA1c decreased significantly over time in the intervention group (8.3 ± 0.6% at the beginning of the study vs. 7.8 ± 1% at the end of the study, p = 0.03). In the intervention group there were also fewer omitted glucose measurements than in the control group. Patients in the

Partner randomized controlled trial: study protocol and coaching intervention

Directory of Open Access Journals (Sweden)

Garbutt Jane M

2012-04-01

Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

The effects of Bobath-based trunk exercises on trunk control, functional capacity, balance, and gait: a pilot randomized controlled trial.

Science.gov (United States)

Kılınç, Muhammed; Avcu, Fatma; Onursal, Ozge; Ayvat, Ender; Savcun Demirci, Cevher; Aksu Yildirim, Sibel

2016-02-01

The aim of this study was to investigate the effects of Bobath-based individually designed trunk exercises on trunk control, upper and lower extremity function, and walking and balance in stroke patients. The main aim of treatment was to eliminate individual trunk impairments during various patient functions. The study was planned as an assessor-blinded, randomized controlled trial. A total of 22 patients volunteered to participate in the study. Trunk function, functional capacity, and gait were assessed with the Trunk Impairment Scale (TIS), stroke rehabilitation assessment of movement (STREAM), and a 10-m walking test, respectively. The Berg Balance Test (BBT), functional reach (FR), and timed up-and-go (TUG) tests were used to evaluate balance. After the initial assessment, the patients were divided randomly into two groups, the study group (12 patients) and the control group (10 patients). The mean age of the patients in the study group was 55.91 years (duration of stroke 58.66 months) and that of the control group was 54.00 years (duration of stroke 67.20 months). Individual training programs were determined for the patients in the study group, taking into consideration their evaluation results; and strengthening, stretching, range of motion, and mat exercises were determined for the control group according to their functional level. The participants in both groups were taken into the physiotherapy program for 12 weeks, 3 days a week for 1 hour a day. In group analyses, both groups showed improvement in STREAM, TIS, and TUG tests. Only the study group produced significant gains in the BBT, FR, and 10 m walking tests (P 0.05). Individually developed exercise programs in the Bobath concept improve trunk performance, balance, and walking ability in stroke patients more than do conventional exercises.

Genome-wide association data classification and SNPs selection using two-stage quality-based Random Forests.

Science.gov (United States)

Nguyen, Thanh-Tung; Huang, Joshua; Wu, Qingyao; Nguyen, Thuy; Li, Mark

2015-01-01

Single-nucleotide polymorphisms (SNPs) selection and identification are the most important tasks in Genome-wide association data analysis. The problem is difficult because genome-wide association data is very high dimensional and a large portion of SNPs in the data is irrelevant to the disease. Advanced machine learning methods have been successfully used in Genome-wide association studies (GWAS) for identification of genetic variants that have relatively big effects in some common, complex diseases. Among them, the most successful one is Random Forests (RF). Despite of performing well in terms of prediction accuracy in some data sets with moderate size, RF still suffers from working in GWAS for selecting informative SNPs and building accurate prediction models. In this paper, we propose to use a new two-stage quality-based sampling method in random forests, named ts-RF, for SNP subspace selection for GWAS. The method first applies p-value assessment to find a cut-off point that separates informative and irrelevant SNPs in two groups. The informative SNPs group is further divided into two sub-groups: highly informative and weak informative SNPs. When sampling the SNP subspace for building trees for the forest, only those SNPs from the two sub-groups are taken into account. The feature subspaces always contain highly informative SNPs when used to split a node at a tree. This approach enables one to generate more accurate trees with a lower prediction error, meanwhile possibly avoiding overfitting. It allows one to detect interactions of multiple SNPs with the diseases, and to reduce the dimensionality and the amount of Genome-wide association data needed for learning the RF model. Extensive experiments on two genome-wide SNP data sets (Parkinson case-control data comprised of 408,803 SNPs and Alzheimer case-control data comprised of 380,157 SNPs) and 10 gene data sets have demonstrated that the proposed model significantly reduced prediction errors and outperformed

[Immediate analgesic effect of wrist-ankle acupuncture for acute lumbago: a randomized controlled trial].

Science.gov (United States)

Su, Jiang-tao; Zhou, Qing-hui; Li, Rui; Zhang, Jie; Li, Wei-hong; Wang, Qiong

2010-08-01

To assess the immediate analgesic effect of wrist-ankle acupuncture on acute lumbago and the relationship between the analgesic effect and the expectation of patients. A randomized, single-blind, sham-controlled trial was designed. Sixty cases of acute lumbago were randomly divided into two groups, 30 cases in each one. In observation group, wrist-ankle acupuncture was adopted to the Lower 5 and Lower 6 bilaterally, no requirement of Deqi (arrival of qi). In control group, sham acupuncture was adopted. The treatment was applied once in either group, with the needles retained for 30 min. The Short-form McGill Pain Questionnaire (SF-MPQ) and the Modified-Modified Schober (MMS) test were used to assess the motion related pain and the situation of spinal flexion in 3 min before treatment and 5 min, 10 min, 15 min, during treatment and 30 min (needle removed), respectively. The Expectation and Treatment Credibility Scale (ETCS) was applied to analyze the relationship between the expectation of patients and the analgesic effect. The adverse reaction was recorded. There were no statistically significant differences in SF-MPQ, MMS and ETCS before treatment between two groups (all P>0.05). In 5 min after needles insertion, the scores of the items in SF-MPQ in observation group were lower than those in control group (P0.05). No adverse reaction was reported. Wrist-ankle acupuncture can reduce acute lumbago immediately and significantly. The higher the expectation on the analgesic effect of wrist-ankle acupuncture the patients have, the better the analgesic effect will be. This therapy is highly safe in the treatment.

A Novel Religious/Spiritual Group Psychotherapy Reduces Depressive Symptoms in a Randomized Clinical Trial.

Science.gov (United States)

Chida, Yoichi; Schrempft, Stephanie; Steptoe, Andrew

2016-10-01

This randomized controlled trial aimed to examine the effect of the Happy Science doctrine-based group psychotherapy on depressive symptoms in 118 Japanese mental disorder outpatients. The treatment group (n = 58) took part in five 90-min sessions at one-week intervals, while the control group (n = 60) received standard care including medication. Depressive symptoms were assessed before the intervention, 5 weeks after the intervention, and at 3-month follow-up. Compared to the control group, the treatment group showed a significant reduction in depressive symptoms both at post-intervention and at 3-month follow-up. In conclusion, this group psychotherapy might be of benefit in treating depressive symptoms.

The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study--a randomized controlled trial

DEFF Research Database (Denmark)

Toft, Ulla; Kristoffersen, Lis; Ladelund, Steen

2008-01-01

Few studies have investigated the specific effect of single intervention components in randomized controlled trials. The purpose was to investigate the effect of adding group-based diet and exercise counselling to individual life-style counselling on long-term changes in dietary habits....

[Relieving pre-exam anxiety syndrome with wrist-ankle acupuncture: a randomized controlled trial].

Science.gov (United States)

Shu, Shi; Li, Tong-ming; Fang, Fan-fu; He, Hou-luo; Zhou, Qing-hui; Gu, Wei; Zhou, Shuang

2011-06-01

Pre-exam anxiety syndrome is a common condition occurring in pre-exam students and directly affects their examination performance and physical state. Wrist-ankle acupuncture has significant therapeutic effects in treating mental disorders and may also relieve the symptoms of pre-exam anxiety syndrome. To assess the therapeutic effect of wrist-ankle acupuncture on pre-exam anxiety syndrome. A total of 60 students who met the inclusion criteria of pre-exam anxiety syndrome were enrolled from a university in Shanghai and they were randomly divided into treatment group and control group. There were 30 cases in each group, and no case failed to follow-up. In the treatment group, wrist-ankle acupuncture was adopted to point upper 1 bilaterally (impression between flexor carpi ulnaris tendon and ulnar margin), and there was no requirement for Deqi (arrival of qi). In the control group, sham acupuncture was adopted. The treatment was applied 3 times totally in both groups one week before the exam, once every other day, each time with the needles retained for 30 min. The therapeutic effects were compared between two groups. Before and after 3 treatments, Sarason Test Anxiety Scale (TAS) and Expectation and Treatment Credibility Scale (ETCS) were measured and evaluated. The therapeutic effect experienced by the treatment group was better than that of the control group (PETCS before treatment between the two groups. The scores of TAS after treatment in two groups were higher than those before treatment (PETCS than those in the control group (P<0.05, P<0.01). No adverse reaction was reported. Wrist-ankle acupuncture can relieve the symptoms of pre-exam anxiety syndrome significantly, and this therapy is highly safe.

Moxibustion for pain relief in patients with primary dysmenorrhea: A randomized controlled trial.

Science.gov (United States)

Yang, Mingxiao; Chen, Xiangzhu; Bo, Linna; Lao, Lixing; Chen, Jiao; Yu, Siyi; Yu, Zheng; Tang, Hongzhi; Yi, Ling; Wu, Xi; Yang, Jie; Liang, Fanrong

2017-01-01

Though moxibustion is frequently used to treat primary dysmenorrhea in China, relevant evidence supporting its effectiveness is still scanty. This study was a pragmatic randomized, conventional drug controlled, open-labeled clinical trial. After initial screen, 152 eligible participants were averagely randomized to receive two different treatment strategies: Moxibustion and conventional drugs. Participants and practitioners were not blinded in this study. The duration of each treatment was 3 months. The primary outcome was pain relief measured by the Visual Analogue Scale. The menstrual pain severity was recorded in a menstrual pain diary. 152 eligible patients were included but only 133 of them eventually completed the whole treatment course. The results showed that the menstrual pain intensity in experimental group and control group was reduced from 6.38±1.28 and 6.41±1.29, respectively, at baseline, to 2.54±1.41 and 2.47±1.29 after treatment. The pain reduction was not significantly different between these two groups (P = 0.76), however; the pain intensity was significantly reduced relative to baseline for each group (Ppain-related symptoms. The serum levels of pain mediators, such as PGF2α, OT, vWF, β-EP, PGE2, were significantly improved after treatment in both groups (Ppain, given their treatment effects and economic costs. This study as a pragmatic trial only demonstrates the effectiveness, not the efficacy, of moxibustion for menstrual pain. It can't rule out the effect of psychological factors during treatment process, because no blind procedure or sham control was used due to availability. In clinical practice, moxibustion should be used at the discretion of patients and their physicians. ClinialTrials.gov NCT01972906.

A Comparison of Web-based and Small-Group Palliative and End-of-Life Care Curricula: A Quasi-Randomized Controlled Study at One Institution

Science.gov (United States)

Day, Frank C.; Srinivasan, Malathi; Der-Martirosian, Claudia; Griffin, Erin; Hoffman, Jerome R.; Wilkes, Michael S.

2014-01-01

Purpose Few studies have compared the effect of web-based eLearning versus small-group learning on medical student outcomes. Palliative and end-of-life (PEOL) education is ideal for this comparison, given uneven access to PEOL experts and content nationally. Method In 2010, the authors enrolled all third-year medical students at the University of California, Davis School of Medicine into a quasi-randomized controlled trial of web-based interactive education (eDoctoring) compared to small-group education (Doctoring) on PEOL clinical content over two months. All students participated in three 3-hour PEOL sessions with similar content. Outcomes included a 24-item PEOL-specific self-efficacy scale with three domains (diagnosis/treatment [Cronbach’s alpha = 0.92, CI: 0.91–0.93], communication/prognosis [alpha = 0.95; CI: 0.93–0.96], and social impact/self-care [alpha = 0.91; CI: 0.88–0.92]); eight knowledge items; ten curricular advantage/disadvantages, and curricular satisfaction (both students and faculty). Results Students were randomly assigned to web-based eDoctoring (n = 48) or small-group Doctoring (n = 71) curricula. Self-efficacy and knowledge improved equivalently between groups: e.g., prognosis self-efficacy, 19%; knowledge, 10–42%. Student and faculty ratings of the web-based eDoctoring curriculum and the small group Doctoring curriculum were equivalent for most goals, and overall satisfaction was equivalent for each, with a trend towards decreased eDoctoring student satisfaction. Conclusions Findings showed equivalent gains in self-efficacy and knowledge between students participating in a web-based PEOL curriculum, in comparison to students learning similar content in a small-group format. Web-based curricula can standardize content presentation when local teaching expertise is limited, but may lead to decreased user satisfaction. PMID:25539518

Effectiveness of a discharge education program in reducing the severity of postpartum depression: a randomized controlled evaluation study.

Science.gov (United States)

Ho, Shiao-Ming; Heh, Shu-Shya; Jevitt, Cecilia M; Huang, Lian-Hua; Fu, Yu-Ying; Wang, Li-Lin

2009-10-01

The effectiveness of a hospital discharge education program including information on postnatal depression was evaluated to reduce psychological morbidity after childbirth. A randomized controlled trial (RCT) was conducted in a regional hospital in Taipei. Two hundred first-time mothers agreed to take part and were randomly allocated to an intervention group (n=100) or control group (n=100). The intervention group received discharge education on postnatal depression provided by postpartum ward nurses. The control group received general postpartum education. The main outcome measure was the Edinburgh Postnatal Depression Scale (EPDS) administered by postal questionnaire at six weeks and three months after delivery. Women who received discharge education intervention on postnatal depression were less likely to have high depression scores when compared to the control group at three months postpartum. A discharge educational intervention including postnatal depression information given to women during the postpartum stay benefits psychological well-being. A postpartum discharge education program including information on postnatal depression should be integrated into postpartum discharge care in general practice. 2009 Elsevier Ireland Ltd.

Topical propolis improves wound healing in patients with diabetic foot ulcer: a randomized controlled trial.

Science.gov (United States)

Afkhamizadeh, Mozhgan; Aboutorabi, Robab; Ravari, Hassan; Fathi Najafi, Mohsen; Ataei Azimi, Sajad; Javadian Langaroodi, Adineh; Yaghoubi, Mohammad Ali; Sahebkar, Amirhossein

2017-08-22

In this randomized controlled trial, diabetic patients with foot ulcers (Wagner grades 1 and 2) were randomly assigned to conventional therapies for diabetic foot ulcer plus topical propolis ointment (5%; twice daily) or conventional therapies alone. The process of ulcer healing was observed during 4 weeks and compared between the two groups regarding the size, erythema, exudates, white blood cell (WBC) count and erythrocyte sedimentation rate (ESR). The process of ulcer size reduction during the four-week period of study was significantly different between the groups. However, this difference was not significant between the third and fourth weeks. There was no significant difference between two groups regarding erythema and exudate reduction as well as WBC count and ESR. Administration of topical propolis ointment in addition to the conventional treatments of diabetic foot ulcer could reduce the size of ulcers with Wagner grades 1 and 2.

Ibuprofen Versus Fennel for the Relief of Postpartum Pain: A Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

Parvin Asti

2011-06-01

Full Text Available Objective: The present study aimed to compare the value of ibuprofen and fennel for postpartum painrelief in women with normal vaginal delivery.Materials and methods:In this randomized clinical trial we studied 90 women referring to obstetricsward for Normal Vaginal Delivery (NVD in Assali hospital in Khoramabad. Women were randomlyallocated to receive either oral ibuprofen or oral fennel by stratified random sampling technique. Allwomen were asked to give pain score by visual analogue scale before and at 1, 2, 3 and 4 hours aftertreatment.Results: Difference between fennel and ibuprofen groups was not significant considering severity of painbefore (P=0.22. Difference between two groups considering mean severity of pain one hour aftertreatment (P=0.57 was not significant. But comparing the mean of pain severity in two groups, showedsignificant difference after two (p<0.023, three (p<0.001 and four (p<0.001 hours after treatment.Conclusion: Ibuprofen and fennel were effective for relief of postpartum pain without any notable sideeffects, but in general ibuprofen was more effective than fennel. More studies are needed to confirm theefficacy of fennel in pain relief especially in postpartum women which must be compared to a notreatment control group.

Early intervention in panic: randomized controlled trial and cost-effectiveness analysis

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van Balkom Anton

2008-11-01

Full Text Available Abstract Background Panic disorder (PD is a common, severe and persistent mental disorder, associated with a high degree of distress and occupational and social disability. A substantial proportion of the population experiences subthreshold and mild PD and is at risk of developing a chronic PD. A promising intervention, aimed at preventing panic disorder onset and reducing panic symptoms, is the 'Don't Panic' course. It consists of eight sessions of two hours each. The purpose of this study is to evaluate the effectiveness of this early intervention – based on cognitive behavioural principles – on the reduction of panic disorder symptomatology. We predict that the experimental condition show superior clinical and economic outcomes relative to a waitlisted control group. Methods/design A pragmatic, pre-post, two-group, multi-site, randomized controlled trial of the intervention will be conducted with a naturalistic follow-up at six months in the intervention group. The participants are recruited from the general population and are randomized to the intervention or a waitlist control group. The intervention is offered by community mental health centres. Included are people over 18 years of age with subthreshold or mild panic disorder, defined as having symptoms of PD falling below the cut-off of 13 on the Panic Disorder Severity Scale-Self Report (PDSS-SR. Primary outcomes are panic disorder and panic symptoms. Secondary outcomes are symptoms of agoraphobia, anxiety, cognitive aspects of panic disorder, depressive symptoms, mastery, health-related quality of life, and cost-effectiveness. We will examine the following variables as potential mediators: cognitive aspects of panic disorder, symptoms of agoraphobia, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics, panic disorder, agoraphobia, treatment credibility and mastery. Discussion This study was designed to evaluate the (cost effectiveness of an

Minimum intervention dentistry approach to managing early childhood caries: a randomized control trial.

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Arrow, Peter; Klobas, Elizabeth

2015-12-01

A pragmatic randomized control trial was undertaken to compare the minimum intervention dentistry (MID) approach, based on the atraumatic restorative treatment procedures (MID-ART: Test), against the standard care approach (Control) to treat early childhood caries in a primary care setting. Consenting parent/child dyads were allocated to the Test or Control group using stratified block randomization. Inclusion and exclusion criteria were applied. Participants were examined at baseline and at follow-up by two calibrated examiners blind to group allocation status (κ = 0.77), and parents completed a questionnaire at baseline and follow-up. Dental therapists trained in MID-ART provided treatment to the Test group and dentists treated the Control group using standard approaches. The primary outcome of interest was the number of children who were referred for specialist pediatric care. Secondary outcomes were the number of teeth treated, changes in child oral health-related quality of life and dental anxiety and parental perceptions of care received. Data were analyzed on an intention to treat basis; risk ratio for referral for specialist care, test of proportions, Wilcoxon rank test and logistic regression were used. Three hundred and seventy parents/carers were initially screened; 273 children were examined at baseline and 254 were randomized (Test = 127; Control = 127): mean age = 3.8 years, SD 0.90; 59% male, mean dmft = 4.9, SD 4.0. There was no statistically significant difference in age, sex, baseline caries experience or child oral health-related quality of life between the Test and Control group. At follow-up (mean interval 11.4 months, SD 3.1 months), 220 children were examined: Test = 115, Control = 105. Case-notes review of 231 children showed Test = 6 (5%) and Control = 53 (49%) were referred for specialist care, P < 0.0001. More teeth were filled in the Test group (mean = 2.93, SD 2.48) than in the Control group (mean = 1.54, SD

Comprehensive self-control training benefits depressed college students: A six-month randomized controlled intervention trial.

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Yang, Xueling; Zhao, Jiubo; Chen, Yu; Zu, Simeng; Zhao, Jingbo

2018-01-15

Depressive disorder was associated with dysfunctional self-regulation. The current study attempted to design and test a comprehensive self-control training (CSCT) program with an overall emphasis on behaviral activation in depressed Chinese college students. Participants included 74 students who had diagnosed with major depression, they were randomly assigned to one of the two groups: intervention group (n=37), and control group (n=37). The intervention participants received an eight-week CSCT and four-month follow-up consolidation program, as compared to the control group who received only pre-post-and-follow-up measurements. All participants measured Beck Depression Inventory (BDI-Ⅱ) and Self-control Scale (SCS) at three time points: baseline, post-training, and four-month follow-up. The dropout rates were 6 (8.1%) in the intervention group and 3 (4.1%) in the control group at the end of six-month intervention. The general linear model repeated measures analysis of variance revealed that comparing with the control group, the intervention group participants had more increase in their trait self-control score, at the meantime, their depressive symptoms had significantly improved. Univariate and logistic regression analyses revealed that participants with milder baseline depressive symptoms were more likely to benefit from CSCT interventions; depression improvement was also associated with the number of sessions attended. The main limitation was related to the small sample size which consisted of college students who were relatively young and well educated. The current study demonstrates that CSCT program could temporarily enhance self-control capacity as well as improve depressive symptoms; participants who are mildly to moderately depressed, and who could adhere to the training protocol are more likely to benefit from the intervention. Copyright © 2017 Elsevier B.V. All rights reserved.

Handcrafted Vacuum-Assisted Device for Skin Ulcers Treatment Versus Traditional Therapy, Randomized Controlled Trial.

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Gonzalez, Israel Gonzalez; Angel, Medina Andrade Luis; Baez, Maria Valeria Jimenez; Ruiz Flores, Brenda; de Los Angeles Martinez Ferretiz, Maria; Woolf, Stephanny Vanestty; López, Israel; Sandoval-Jurado, Luis; Pat-Espadas, Fany Guadalupe; Cruz, Alan Alejandro Reyes; Delgado, Arsenio Torres

2017-02-01

Chronic lower limb ulcers constitute a public health problem, with important socioeconomic implications and high attention cost. This trial evaluates handcrafted vacuum-assisted therapy versus traditional treatment effectiveness for lower limbs ulcers. It was a prospective randomized clinical trial conducted over 144 patients with lower limbs ulcers. Patients were randomized into two groups of 72 patients: Experimental group were treated with debridement, cure and a handcrafted vacuum-assisted device that was changed every 72 h. Control group was treated with debridement and cure with soap every 24 h. Ulcers were evaluated every 72 h and on 10th day. The presence of systemic inflammatory response, pain, granulation tissue and viability for discharge was registered and analyzed . After exclusion of 18 patients, 126 were included, 65.1% were men with an average of 58 years. Sole region ulcer by diabetic foot was the more frequent in both groups (73%). Leukocytes count, systemic inflammatory response and pain were significantly lower in experimental group (p ulcers. This system would benefit patients favoring earlier infection control, faster granulation tissue appearance and earlier discharge. Clinical trials registered in https://www.clinicaltrials.gov/ Number NCT02512159.

Irisin and exercise training in humans - results from a randomized controlled training trial.

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Hecksteden, Anne; Wegmann, Melissa; Steffen, Anke; Kraushaar, Jochen; Morsch, Arne; Ruppenthal, Sandra; Kaestner, Lars; Meyer, Tim

2013-11-05

The recent discovery of a new myokine (irisin) potentially involved in health-related training effects has gained great attention, but evidence for a training-induced increase in irisin remains preliminary. Therefore, the present study aimed to determine whether irisin concentration is increased after regular exercise training in humans. In a randomized controlled design, two guideline conforming training interventions were studied. Inclusion criteria were age 30 to 60 years, Physical performance provided positive control for the overall efficacy of training. Differences between groups were tested for significance using analysis of variance. For post hoc comparisons with the control group, Dunnett's test was used. Maximum performance increased significantly in the training groups compared with controls (controls: ±0.0 ± 0.7 km/h; AET: 1.1 ± 0.6 km/h, P error probability = 0.7). The general upward trend was mainly accounted for by a negative association of irisin concentration with the storage duration of frozen serum samples (P storage of samples from initial tests.

Making Healthy Eating Policy Practice: A Group Randomized Controlled Trial on Changes in Snack Quality, Costs, and Consumption in After-School Programs.

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Beets, Michael W; Weaver, R Glenn; Turner-McGrievy, Gabrielle; Huberty, Jennifer; Ward, Dianne S; Freedman, Darcy; Hutto, Brent; Moore, Justin B; Beighle, Aaron

2016-09-01

The aim of this study was to evaluate an intervention designed to assist after-school programs (ASPs) in meeting snack nutrition policies that specify that a fruit or vegetable be served daily and sugar-sweetened beverages/foods and artificially flavored foods eliminated. The study used a 1-year group-randomized controlled trial. The study took place in ASPs operating in South Carolina, United States. Twenty ASPs serving over 1700 children were recruited, match-paired postbaseline on enrollment size and days fruits/vegetables were served per week, and randomized to either intervention (n = 10) or control (n = 10) groups. The study used Strategies To Enhance Practice for Healthy Eating (STEPs-HE), a multistep adaptive intervention framework that assists ASP leaders and staff to serve snacks that meet nutrition policies while maintaining cost. Direct observation of snacks served and consumed and monthly snack expenditures as determined by receipts were used. The study used nonparametric and mixed-model repeated measures. By postassessment, intervention ASPs increased serving of fruits/vegetables to 3.9 ± 2.1 vs. 0.7 ± 1.7 d/wk and decreased serving sugar-sweetened beverages to 0.1 ± 0.7 vs. 1.8 ± 2.4 d/wk and sugar-sweetened foods to 0.3 ± 1.1 vs. 2.7 ± 2.5 d/wk compared to controls, respectively. Cost of snacks increased by $0.02/snack in the intervention ASPs ($0.36 to $0.38) compared to a $0.01 per snack decrease in the control group ($0.39 to $0.38). Across both assessments and groups, 80% to 100% of children consumed FVs. The STEPs-HE intervention can assist ASPs in meeting nationally endorsed nutrition policies with marginal increases in cost. © 2016 by American Journal of Health Promotion, Inc.

One-site versus two-site phacotrabeculectomy: a prospective randomized study

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Moschos MM

2015-08-01

Full Text Available Marilita M Moschos,1 Irini P Chatziralli,2 Michael Tsatsos3 1First Department of Ophthalmology, University of Athens, 2Second Department of Ophthalmology, Ophthalmiatrion Athinon, Athens, Greece; 3Department of Ophthalmology, Cambridge University Hospital NHS, Cambridge, UK Purpose: The purpose of this study is to compare the efficacy and safety of one-site and two-site combined phacotrabeculectomy with foldable posterior chamber intraocular lens implantation.Methods: Thirty-four patients (41 eyes with glaucoma and cataract were randomly assigned to undergo either a one-site (22 eyes or a two-site (19 eyes combined procedure. One-site approach consisted of a standard superior phacotrabeculectomy with a limbus-based conjunctival flap, while two-site approach consisted of a clear cornea phacoemulsification and a separate superior trabeculectomy with a limbus-based conjunctival flap.Results: Mean follow-up period was 54 months (standard deviation [SD] 2.3. Mean preoperative intraocular pressure (IOP in the one-site group was 21.3 mmHg (SD 2.8 and in the two-site group was 21.8 mmHg (SD 3.0 (P>0.1. Mean postoperative IOP significantly decreased in both groups compared to the preoperative level and was 15.6 mmHg (SD 3.5 in the one-site group and 14.9 mmHg (SD 2.7 in the two-site group. Three months later, the difference between the two groups was not statistically significant (P=0.058. The one-site group required significantly more medications than the two-site group (P=0.03. Best-corrected visual acuity (BCVA improved similarly in both groups, but there was less postoperative (induced astigmatism in the two-site group in a marginal statistical level (P=0.058. Intra- and postoperative complications were comparable in the two groups.Conclusion: Both techniques yielded similar results concerning final BCVA and IOP reduction. However, the two-site group had less induced astigmatism and a better postoperative IOP control with less required

Does the incorporation of portion-control strategies in a behavioral program improve weight loss in a 1-year randomized controlled trial?

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Rolls, B J; Roe, L S; James, B L; Sanchez, C E

2017-03-01

Controlling food portion sizes can help reduce energy intake, but the effect of different portion-control methods on weight management is not known. In a 1-year randomized trial, we tested whether the efficacy of a behavioral weight-loss program was improved by incorporating either of the two portion-control strategies instead of standard advice about eating less. The Portion-Control Strategies Trial included 186 women with obesity (81%) or overweight (19%). Participants were randomly assigned to one of three equally intensive behavioral programs, consisting of 19 individual sessions over 12 months. The Standard Advice Group was instructed to eat less food while making healthy choices, the Portion Selection Group was instructed to choose portions based on the energy density using tools such as food scales and the Pre-portioned Foods Group was instructed to structure meals around pre-portioned foods such as single-serving main dishes, for which some vouchers were provided. In an intention-to-treat analysis, a mixed-effects model compared weight loss trajectories across 23 measurements; at month 12, weight was measured for 151 participants (81%). The trajectories showed that the Pre-portioned Foods Group initially lost weight at a greater rate than the other two groups (P=0.021), but subsequently regained weight at a greater rate (P=0.0005). As a result, weight loss did not differ significantly across groups at month 6 (mean±s.e. 5.2±0.4 kg) or month 12 (4.5±0.5 kg). After 1 year, measured weight loss averaged 6% of baseline weight. The frequency of using portion-control strategies initially differed across groups, then declined over time and converged at months 6 and 12. Incorporating instruction on portion-control strategies within a 1-year behavioral program did not lead to a greater weight loss than standard advice. Using pre-portioned foods enhanced early weight loss, but this was not sustained over time. Long-term maintenance of behavioral strategies to

Benfotiamine in the treatment of diabetic polyneuropathy--a three-week randomized, controlled pilot study (BEDIP study).

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Haupt, E; Ledermann, H; Köpcke, W

2005-02-01

The aim of the study was to evaluate the efficacy of benfotiamine administered over three weeks (allithiamine; a lipid-soluble vitamin B1 prodrug with high bioavailability) to patients with diabetic polyneuropathy in a randomized, placebo-controlled, double-blind, two-center pilot study. Forty inpatients (23 male, 18 female, age range 18 - 70 years) with a history of type 1 or 2 diabetes and polyneuropathy of not longer than two years, were included in the study. Twenty Patients received two 50 mg benfotiamine tablets four times daily and 20 patients received placebo over the three-week study period. Two clinical units were involved with 10 patients receiving placebo and 10 patients benfotiamine in each. The neuropathy score according to Katzenwadel et al. [1987] was used to evaluate symptoms of polyneuropathy, vibration perception threshold and both the physician's and the patient's own assessment were documented. A statistically significant (p = 0.0287) improvement in the neuropathy score was observed in the group given active drug when compared to the placebo-treated controls. There was no statistically significant change observed in the tuning fork test. The most pronounced effect on complaints was a decrease in pain (p = 0.0414). More patients in the benfotiamine-treated group than in the placebo group considered their clinical condition to have improved (p = 0.052). No side effects attributable to benfotiamine were observed. The differences between the groups cannot be attributed to a change in metabolic parameters since there were no significant alterations in the HbA1 levels and blood sugar profiles. The body mass index of the two groups did not differ. This pilot investigation (BEDIP Study) has confirmed the results of two earlier randomized controlled trials and has provided further evidence for the beneficial effects of benfotiamine in patients with diabetic neuropathy.

Dry cupping for plantar fasciitis: a randomized controlled trial.

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Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

2017-05-01

[Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59 years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome measurements included the Visual Analogue Pain Scale (VAS) (at rest, first in the morning, and with activities), the Foot and Ankle Ability Measure (FAAM), the Lower Extremity Functional Scale (LEFS), as well as the pressure pain threshold. [Results]The data indicated that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function significantly in the population tested, as all the 95% Confidence Intervals (CIs) did not include 0 except for the pressure pain threshold. There was no significant difference between the dry cupping therapy and electrical stimulation groups in all the outcome measurements. [Conclusion] These results support that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function in the population tested.

The effects of laughter therapy on mood state and self-esteem in cancer patients undergoing radiation therapy: a randomized controlled trial.

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Kim, So Hee; Kook, Jeong Ran; Kwon, Moonjung; Son, Myeong Ha; Ahn, Seung Do; Kim, Yeon Hee

2015-04-01

To investigate whether laughter therapy lowers total mood disturbance scores and improves self-esteem scores in patients with cancer. Randomized controlled trial in a radio-oncology outpatient setting. Sixty-two patients were enrolled and randomly assigned to the experimental group (n=33) or the wait list control group (n=29). Three laughter therapy sessions lasting 60 minutes each. Mood state and self-esteem. The intention-to-treat analysis revealed a significant main effect of group: Experimental group participants reported a 14.12-point reduction in total mood disturbance, while the wait list control group showed a 1.21-point reduction (p=0.001). The per-protocol analysis showed a significant main effect of group: The experimental group reported a 18.86-point decrease in total mood disturbance, while controls showed a 0.19-point reduction (plaughter therapy can improve mood state and self-esteem and can be a beneficial, noninvasive intervention for patients with cancer in clinical settings.

Effects of fixed orthodontic treatment and two new mouth rinses on gingival health: A prospective cohort followed by a single-blind placebo-controlled randomized clinical trial.

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Sobouti, Farhad; Rakhshan, Vahid; Heydari, Mohaddeseh; Keikavusi, Shohreh; Dadgar, Sepideh; Shariati, Mahsa

2018-03-01

Routine brushing protocols might not suffice to reduce the increased plaque accumulation in orthodontic patients. Antimicrobial mouth rinses are favorable in this regard. This two-phase study evaluated the effects of orthodontic treatment and the application of two mouthwashes not studied before on oral health indices. In this two-phase study (a prospective cohort followed by a parallel randomized controlled trial), plaque index (PI), gingival index (GI), gingival bleeding index (GBI), and pocket probing depth (PPD) were measured in 54 orthodontic patients before orthodontic treatment and 4 months later. Then patients were randomized into three groups of mouthrinses: Persica (herbal), Ortho-Kin (containing diluted chlorhexidine), and Placebo (n=18×3). The effects of orthodontic treatment and mouthrinses were analyzed statistically (α=0.05). All the 4 indices increased between the baseline and 4th month of treatment (P values<0.01, paired t-test). They decreased back to baseline levels or below them, after one month of mouthwash application (P values<0.002). Both mouthwashes showed therapeutic effects compared to placebo in terms of PI and GBI. In the case of GI, only Persica showed significantly better results compared to placebo. Regarding PPD, only Ortho-Kin acted better than placebo (P values≤0.05, Tukey). Lack of positive control (regular chlorhexidine mouth rinse) and negative control (a group with no mouthwashes, even without the placebo). Lack of sample size predetermination based on a priori power calculations. The difference between the regime of Persica with that of Ortho-Kin and placebo (which had similar application protocols) disallowed perfectly effective blinding of the patients (hence, single-blind). Fixed orthodontic treatment might disrupt gingival health. Antimicrobial mouthwashes might reverse this. Both evaluated mouthwashes might have therapeutic effects. Copyright © 2018 CEO. Published by Elsevier Masson SAS. All rights reserved.

Prosthodontic maintenance of overdentures on zirconia implants: 1-year results of a randomized controlled trial.

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Osman, Reham B; Ma, Sunyoung

2014-01-01

The purpose of this study was to determine the prosthodontic outcomes of one-piece zirconia implants and their attachment systems in edentulous participants with maxillary and mandibular overdentures after 1 year of a randomized controlled trial. Random allocation of 24 edentulous participants (age range: 45 to 86 years) into titanium (control) or zirconia (test) groups using onepiece implants and a planned unsplinted prosthodontic design was performed. Four maxillary implants (one midpalatal; three anterior crestal) and three mandibular implants (one midsymphyseal; two bilateral distal) were conventionally loaded with the overdentures. Similar attachment systems were used throughout: ball abutment-type patrices (diameter: 2.25 to 3.1 mm as part of the one-piece implants) and custommade plastic matrices (with or without metal housings depending on the patrix size). Prosthodontic outcomes were documented during the first year of the clinical trial. Following three deaths and two dropouts, there were 19 participants who were available at the 1-year recall. Of these participants, 3 had early maxillary implant failure and had to be converted to conventional maxillary complete dentures opposing mandibular implant overdentures. There were 79 maintenance events, 34 in the titanium (control) group and 45 in the zirconia (test) group. Patrix loss occurred as a result of three zirconia implant fractures (one mandibular and two crestal maxillary implants). Maintenance events were principally the replacement of matrices and overdenture fracture. Although relines and replacement overdentures also occurred, overall there were no significant differences in prosthodontic maintenance between the control and test groups. A six-field prosthodontic-success analysis table showed no statistically significant difference between the two groups; however, 50% of participants in each group were allocated to the retreatment (repair) field, which produced a low prosthodontic success rate

A randomized controlled trial of cell salvage in routine cardiac surgery.

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Klein, Andrew A; Nashef, Samer A M; Sharples, Linda; Bottrill, Fiona; Dyer, Matthew; Armstrong, Johanna; Vuylsteke, Alain

2008-11-01

Previous trials have indicated that cell salvage may reduce allogeneic blood transfusion during cardiac surgery, but these studies have limitations, including inconsistent use of other blood transfusion-sparing strategies. We designed a randomized controlled trial to determine whether routine cell salvage for elective uncomplicated cardiac surgery reduces blood transfusion and is cost effective in the setting of a rigorous transfusion protocol and routine administration of antifibrinolytics. Two-hundred-thirteen patients presenting for first-time coronary artery bypass grafting and/or cardiac valve surgery were prospectively randomized to control or cell salvage groups. The latter group had blood aspirate during surgery and mediastinal drainage the first 6 h after surgery processed in a cell saver device and autotransfused. All patients received tranexamic acid and were subjected to an algorithm for red blood cell and hemostatic blood factor transfusion. There was no difference between the two groups in the proportion of patients exposed to allogeneic blood (32% in both groups, relative risk 1.0 P = 0.89). At current blood products and cell saver prices, the use of cell salvage increased the costs per patient by a minimum of $103. When patients who had mediastinal re-exploration for bleeding were excluded (as planned in the protocol), significantly fewer units of allogeneic red blood cells were transfused in the cell salvage compared with the control group (65 vs 100 U, relative risk 0.71 P = 0.04). In patients undergoing routine first-time cardiac surgery in an institution with a rigorous blood conservation program, the routine use of cell salvage does not further reduce the proportion of patients exposed to allogeneic blood transfusion. However, patients who do not have excessive bleeding after surgery receive significantly fewer units of blood with cell salvage. Although the use of cell savage may reduce the demand for blood products during cardiac surgery, this

Two new mini-slings compared with transobturator tension-free vaginal tape for treatment of stress urinary incontinence: A 1-year follow-up randomized controlled trial.

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Gaber, Mohamed E; Borg, Tamer; Samour, Hazem; Nawara, Mai; Reda, Ahmed

2016-12-01

The aim of this study was to compare the outcome of two single-incision mini-slings (the Contasure-Needleless [C-NDL] and the endopelvic free anchorage) with the standard midurethral transobturator tension-free vaginal tape (TVT-O) procedure. A double blind randomized controlled study was conducted at Ain Shams University Maternity Hospital from August 2014 until July 2015. A total of 209 patients were randomized into three groups. The first group underwent the TVT-O procedure, the second group underwent the endopelvic free anchorage procedure and the third group underwent the C-NDL procedure. Patients were followed up for 12 months in terms of subjective cure, objective cure, and complications rate. After 12 months of follow-up, there were no differences among the three groups in terms of objective cure rate, subjective cure rate, patient satisfaction, or incidence of complications (de novo urge, hemorrhage, infection, and mesh erosion). The C-NDL was associated with a shorter operative time (P < 0.001) and less blood loss (P = 0.021) than the standard TVT-O. The new single-incision mini-slings showed similar efficacy and patient acceptance to that of the standard TVT-O for up to 12 months postoperatively with no difference in the complications rate. The C-NDL is associated with shorter operative time and less blood loss. © 2016 Japan Society of Obstetrics and Gynecology.

Nifedipine as a uterine relaxant for external cephalic version: a randomized controlled trial.

Science.gov (United States)

Kok, Marjolein; Bais, Joke M; van Lith, Jan M; Papatsonis, Dimitri M; Kleiverda, Gunilla; Hanny, Dahrs; Doornbos, Johannes P; Mol, Ben W; van der Post, Joris A

2008-08-01

To estimate the effectiveness of nifedipine as a uterine relaxant during external cephalic version to correct breech presentation. In this randomized, double-blind, placebo-controlled trial, women with a singleton fetus in breech presentation and a gestational age of 36 weeks or more were eligible for enrollment. Participating women received two doses of either nifedipine 10 mg or placebo, 30 and 15 minutes before the external cephalic version attempt. The primary outcome was a cephalic-presenting fetus immediately after the procedure. Secondary outcome measures were cephalic presentation at delivery, mode of delivery, and adverse events. A sample size of 292 was calculated to provide 80% power to detect a 17% improvement of the external cephalic version success rate, assuming a placebo group rate of 40% and alpha of .05. Outcome data for 310 of 320 randomly assigned participants revealed no significant difference in external cephalic version success rates between treatment (42%) and control group (37%) (relative risk 1.1, 95%; 95% confidence interval 0.85-1.5). The cesarean delivery rate was 51% in the treatment group and 46% in the control group (relative risk 1.1, 95% confidence interval 0.88-1.4). Nifedipine did not significantly improve the success of external cephalic version. Future use of nifedipine to improve the outcome of external cephalic version should be limited to large clinical trials.

Effect of continuous oral suctioning on the development of ventilator-associated pneumonia: a pilot randomized controlled trial.

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Chow, Meyrick C M; Kwok, Shu-Man; Luk, Hing-Wah; Law, Jenny W H; Leung, Bartholomew P K

2012-11-01

Both continuous and intermittent aspiration of subglottic secretions by means of specially designed endotracheal tubes containing a separate dorsal lumen that opens into the subglottic region have been shown to be useful in reducing ventilator-associated pneumonia (VAP). However, the high cost of these tubes restricts their use. The aim of this pilot randomized controlled trial was to test the effect of a low-cost device (saliva ejector) for continuous oral suctioning (COS) on the incidence of VAP in patients receiving mechanical ventilation. The study was conducted in the six-bed medical-surgical ICU of a hospital with over 400 beds that provides comprehensive medical services to the public. The design of this study was a parallel-group randomized controlled trial. While both the experimental and control groups used the conventional endotracheal tube, the saliva ejector was only applied to patients assigned to the experimental group. The device was put between the patient's cheek and teeth, and then connected to 100mmHg of suction for the continuous drainage of saliva. Fourteen patients were randomized to receive COS and 13 patients were randomized to the control group. The two groups were similar in demographics, reasons for intubation, co-morbidity, and risk factors for acquiring VAP. VAP was found in 3 patients (23.1%; 71 episodes of VAP per 1000 ventilation days) receiving COS and in 10 patients (83.3%; 141 episodes of VAP per 1000 ventilation days) in the control group (relative risk, 0.28; 95% confidence interval, 0.10-0.77; p=0.003). The duration of mechanical ventilation in the experimental group was 3.2 days (SD 1.3), while that in the control group was 5.9 days (SD 2.8) (p=0.009); and the length of ICU stay was 4.8 days (SD 1.6) versus 9.8 days (SD 6.3) for the experimental and control groups, respectively (p=0.019). Continuous clearance of oral secretion by the saliva ejector may have an important role to play in reducing the rate of VAP, decreasing the

CHILE: Outcomes of a group randomized controlled trial of an intervention to prevent obesity in preschool Hispanic and American Indian children.

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Davis, Sally M; Myers, Orrin B; Cruz, Theresa H; Morshed, Alexandra B; Canaca, Glenda F; Keane, Patricia C; O'Donald, Elena R

2016-08-01

We examined the outcomes of the Child Health Initiative for Lifelong Eating and Exercise (CHILE) study, a group randomized controlled trial to design, implement, and test the efficacy of a trans-community intervention to prevent obesity in children enrolled in Head Start centers in rural American Indian and Hispanic communities in New Mexico. CHILE was a 5-year evidence-based intervention that used a socioecological approach to improving dietary intake and increasing physical activity of 1898 children. The intervention included a classroom curriculum, teacher and food service training, family engagement, grocery store participation, and healthcare provider support. Height and weight measurements were obtained four times (fall of 2008, spring and fall of 2009, and spring of 2010), and body mass index (BMI) z-scores in the intervention and comparison groups were compared. At baseline, demographic characteristics in the comparison and intervention groups were similar, and 33% of all the children assessed were obese or overweight. At the end of the intervention, there was no significant difference between the two groups in BMI z-scores. Obesity prevention research among Hispanic and AI preschool children in rural communities is challenging and complex. Although the CHILE intervention was implemented successfully, changes in overweight and obesity may take longer than 2years to achieve. Copyright © 2016 Elsevier Inc. All rights reserved.

Comparison of single-dose nalbuphine versus tramadol for postoperative pain management in children: a randomized, controlled trial.

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Liaqat, Naeem; Dar, Sajid Hameed

2017-04-01

Acute postoperative pain control in children is an essential component of postoperative care, particularly in daycare procedures. Giving patients continuous narcotic analgesics can be risky; however, a single dose may be sufficient. This study used a prospective, randomized controlled design and was conducted at the Pediatric Surgery Unit, Services Hospital, Lahore. In total, 150 patients who underwent inguinal herniotomy (age range: 1-12 years) were randomly assigned to two groups: group A (nalbuphine) and group B (tramadol). Patients were given a single dose of either nalbuphine (0.2 mg/kg) or tramadol (2 mg/kg) immediately after surgery and pain was measured at 0, 1, 2, 4, and 8 h. The demographic characteristics were similar between the two groups. The mean pain score was lower in group A than in group B at 0 and 1 h (P pain scores in group A were still lower, but not significantly. In all, 9 patients (12.0%) required rescue analgesics in group A compared to 16 patients (21.3%) in group B (P = 0.051). The mean time for requirement of rescue analgesics was 6.5 ± 0.5 h in group A and 5.3 ± 1.7 h in group B (P = 0.06). A single dose of nalbuphine is sufficient, and superior to tramadol, for postoperative pain management in children who have undergone daycare procedures.

Effect of music in endoscopy procedures: systematic review and meta-analysis of randomized controlled trials.

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Wang, Man Cai; Zhang, Ling Yi; Zhang, Yu Long; Zhang, Ya Wu; Xu, Xiao Dong; Zhang, You Cheng

2014-10-01

Endoscopies are common clinical examinations that are somewhat painful and even cause fear and anxiety for patients. We performed this systematic review and meta-analysis of randomized controlled trials to determine the effect of music on patients undergoing various endoscopic procedures. We searched the Cochrane Library, Issue 6, 2013, PubMed, and EMBASE databases up to July 2013. Randomized controlled trials comparing endoscopies, with and without the use of music, were included. Two authors independently abstracted data and assessed risk of bias. Subgroup analyses were performed to examine the impact of music on different types of endoscopic procedures. Twenty-one randomized controlled trials involving 2,134 patients were included. The overall effect of music on patients undergoing a variety of endoscopic procedures significantly improved pain score (weighted mean difference [WMD] = -1.53, 95% confidence interval [CI] [-2.53, -0.53]), anxiety (WMD = -6.04, 95% CI [-9.61, -2.48]), heart rate (P = 0.01), arterial pressure (P music group, compared with the control group. Furthermore, music had little effect for patients undergoing colposcopy and bronchoscopy in the subanalysis. Our meta-analysis suggested that music may offer benefits for patients undergoing endoscopy, except in colposcopy and bronchoscopy. Wiley Periodicals, Inc.

Efficacy of an internet-based learning module and small-group debriefing on trainees' attitudes and communication skills toward patients with substance use disorders: results of a cluster randomized controlled trial.

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Lanken, Paul N; Novack, Dennis H; Daetwyler, Christof; Gallop, Robert; Landis, J Richard; Lapin, Jennifer; Subramaniam, Geetha A; Schindler, Barbara A

2015-03-01

To examine whether an Internet-based learning module and small-group debriefing can improve medical trainees' attitudes and communication skills toward patients with substance use disorders (SUDs). In 2011-2012, 129 internal and family medicine residents and 370 medical students at two medical schools participated in a cluster randomized controlled trial, which assessed the effect of adding a two-part intervention to the SUDs curricula. The intervention included a self-directed, media-rich Internet-based learning module and a small-group, faculty-led debriefing. Primary study outcomes were changes in self-assessed attitudes in the intervention group (I-group) compared with those in the control group (C-group) (i.e., a difference of differences). For residents, the authors used real-time, Web-based interviews of standardized patients to assess changes in communication skills. Statistical analyses, conducted separately for residents and students, included hierarchical linear modeling, adjusted for site, participant type, cluster, and individual scores at baseline. The authors found no significant differences between the I- and C-groups in attitudes for residents or students at baseline. Compared with those in the C-group, residents, but not students, in the I-group had more positive attitudes toward treatment efficacy and self-efficacy at follow-up (Pcommunication skills toward patients with SUDs among residents. Enhanced attitudes and skills may result in improved care for these patients.

Effects of Gua-Sha therapy on breast engorgement: a randomized controlled trial.

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Chiu, Jin-Yu; Gau, Meei-Ling; Kuo, Shu-Yu; Chang, Yung-Hsien; Kuo, Su-Chen; Tu, Hui-Chuan

2010-03-01

Breast engorgement is a common problem that affects the initiation and duration of breastfeeding. Limited solutions are available to relieve the discomfort associated with breast engorgement. Thus, further investigation of methods to achieve effective relief of symptoms is critical to promote breastfeeding success. : The purpose of this study was to determine the effects of two breast care methods, that is, scraping (Gua-Sha) therapy (administered to the experimental group) and traditional breast care (i.e., massage and heating; administered to the control group). A randomized controlled trial was conducted on 54 postpartum women at a Level III medical teaching hospital. Participant inclusion criteria included postpartum breastfeeding women (a) who had an uncomplicated delivery and (b) who were experiencing breast engorgement problems. The Gua-Sha protocol selected appropriate acupoint positions, which included ST16, ST18, SP17, and CV17. Each position was lightly scraped seven times in two cycles. For the control group, we used hot packs and massage for 20 min in accordance with recommendations given in an obstetrical technique textbook. Results showed no statistical differences between the two groups at baseline. Body temperature, breast temperature, breast engorgement, pain levels, and discomforting levels were statistically different between the two groups at 5 and 30 min after intervention (p account. Our findings provided empirical evidence supporting that Gua-Sha therapy may be used as an effective technique in the management of breast engorgement. By using Gua-Sha therapy, nurses can handle breast engorgement problems more effectively in primary care and hence help patients both physically and psychologically.

Fast neutrons in the treatment of head and neck cancers: the results of a multi-centre randomly controlled trial

International Nuclear Information System (INIS)

Duncan, W.; Arnott, S.J.; Orr, J.A.; Kerr, G.R.; Schmitt, G.

1984-01-01

The results are presented of a multi-centre randomly controlled trial of fast neutron irradiation and mega-voltage X-rays in the treatment of patients with locally advanced squamous cell carcinoma of the head and neck region. No significant difference was observed in local tumour control rates. Salvage surgery was performed in a similar number of patients in the two groups. Late morbidity was also similar in the two treatment groups. Patients in a subgroup with cancer of the larynx treated by photons had a significantly better survival than those in the neutron treated group. (Auth.)

Making healthy eating policy practice: A group randomized controlled trial on changes in snack quality, costs, and consumption in after school programs

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Beets, Michael W.; Weaver, R. Glenn; Turner-McGrievy, Gabrielle; Huberty, Jennifer; Ward, Dianne S.; Freedman, Darcy; Hutto, Brent; Moore, Justin B.; Beighle, Aaron

2017-01-01

Purpose The aim of this study was to evaluate an intervention designed to assist after school programs (ASPs) in meeting snack nutrition policies that specify that a fruit or vegetable (FV) be served daily, and sugar-sweetened beverages/foods and artificially flavored foods eliminated. Design One-year group randomized controlled trial Setting Afterschool programs operating in South Carolina, US. Subjects Twenty ASPs serving over 1,700 children were recruited, match-paired post-baseline on enrollment size and days FV were served/week (days/wk), and randomized to either an intervention (n=10) or control (n=10) groups. Intervention Strategies To Enhance Practice for Healthy Eating (STEPs-HE), a multi-step adaptive intervention framework, which assists ASP leaders and staff to serve snacks that meet nutrition policies while maintaining cost. Measures Direct observation of snacks served and consumed, and monthly snack expenditures via receipts. Analysis Nonparametric and mixed-model repeated-measures Results By post-assessment, intervention ASPs increased serving FV to 3.9±2.1 vs. 0.7±1.7days/wk and decreased serving sugar-sweetened beverages to 0.1±0.7 vs. 1.8±2.4days/wk and foods to 0.3±1.1 vs. 2.7±2.5days/wk compared to controls, respectively. Cost of snacks increased by $0.02/snack in the intervention ASPs ($0.36 to $0.38) compared to a $0.01/snack decrease in the control ($0.39 to $0.38). Across both assessments and groups 80–100% of children consumed FV. Conclusions The STEPs-HE intervention can assist ASPs in meeting nationally endorsed nutrition policies with marginal increases in cost. PMID:26158679

Pain control in laparoscopic gynecologic surgery with/without preoperative (preemptive) parecoxib sodium injection: a randomized study.

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Ratchanon, Sarwinee; Phaloprakarn, Chadakarn; Traipak, Khanitta

2011-10-01

To determine the effectiveness of preoperative parecoxib sodium injection for pain relief after laparoscopic gynecologic surgery. A prospective double-blind, randomized study was conducted in 268 patients who underwent laparoscopic gynecologic surgery at Vajira Hospital between November 1, 2010 and March 31, 2011. The patients were randomly allocated into two groups to receive either single intravenous 40 mg parecoxib (treatment group; n = 133) or normal saline (control group; n = 135) 30 min before surgery. The degree of postoperative pain was assessed every 2 h in the first 8 h postoperation, then every 4 h until completion of 24 h by using a verbal rating scale. Total consumption of meperidine over a 24-h period and the adverse events relevant to parecoxib sodium were also recorded. Mean pain scores at all measured times in the treatment group were insignificantly lower than those in the control group (p = 0.106). The mean 24-h postoperative meperidine consumption in the treatment group was significantly lower compared to that in the control group (26.3 +/- 28.1 mg and 39.1 +/- 34.6 mg, respectively, p = 0.001). The proportion of patients requiring meperidine in the treatment group was significantly lower than that in the control group (58.6% and 70.3%, respectively, p = 0. 045). No serious adverse events were observed in both groups. Preoperative parecoxib sodium significantly reduced postoperative meperidine requirement and consumption, while insignificantly declined the pain scores. Serious adverse events were not encountered

Independent exercise for glottal incompetence to improve vocal problems and prevent aspiration pneumonia in the elderly: a randomized controlled trial.

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Fujimaki, Yoko; Tsunoda, Koichi; Kobayashi, Rika; Tonghyo, Chong; Tanaka, Fujinobu; Kuroda, Hiroyuki; Numata, Tsutomu; Ishii, Toyota; Kuroda, Reiko; Masuda, Sawako; Hashimoto, Sho; Misawa, Hayato; Shindo, Naoko; Mori, Takahiro; Mori, Hiroko; Uchiyama, Naoki; Kamei, Yuichirou; Tanaka, Masashi; Hamaya, Hironobu; Funatsuki, Shingo; Usui, Satoko; Ito, Ikuno; Hamada, Kohei; Shindo, Akihito; Tokumaru, Yutaka; Morita, Yoko; Ueha, Rumi; Nito, Takaharu; Kikuta, Shu; Sekimoto, Sotaro; Kondo, Kenji; Sakamoto, Takashi; Itoh, Kenji; Yamasoba, Tatsuya; Matsumoto, Sumio

2017-08-01

To evaluate the effect of a self-controlled vocal exercise in elderly people with glottal closure insufficiency. Parallel-arm, individual randomized controlled trial. Patients who visited one of 10 medical centers under the National Hospital Organization group in Japan for the first time, aged 60 years or older, complaining of aspiration or hoarseness, and endoscopically confirmed to have glottal closure insufficiency owing to vocal cord atrophy, were enrolled in this study. They were randomly assigned to an intervention or a control group. The patients of the intervention group were given guidance and a DVD about a self-controlled vocal exercise. The maximum phonation time which is a measure of glottal closure was evaluated, and the number of patients who developed pneumonia during the six months was compared between the two groups. Of the 543 patients enrolled in this trial, 259 were allocated into the intervention group and 284 into the control; 60 of the intervention group and 75 of the control were not able to continue the trial. A total of 199 patients (age 73.9 ±7.25 years) in the intervention group and 209 (73.3 ±6.68 years) in the control completed the six-month trial. Intervention of the self-controlled vocal exercise extended the maximum phonation time significantly ( p < 0.001). There were two hospitalizations for pneumonia in the intervention group and 18 in the control group, representing a significant difference ( p < 0.001). The self-controlled vocal exercise allowed patients to achieve vocal cord adduction and improve glottal closure insufficiency, which reduced the rate of hospitalization for pneumonia significantly. gov Identifier-UMIN000015567.

Manage at work: a randomized, controlled trial of a self-management group intervention to overcome workplace challenges associated with chronic physical health conditions.

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Shaw, William S; Besen, Elyssa; Pransky, Glenn; Boot, Cécile R L; Nicholas, Michael K; McLellan, Robert K; Tveito, Torill H

2014-05-28

The percentage of older and chronically ill workers is increasing rapidly in the US and in many other countries, but few interventions are available to help employees overcome the workplace challenges of chronic pain and other physical health conditions. While most workers are eligible for job accommodation and disability compensation benefits, other workplace strategies might improve individual-level coping and problem solving to prevent work disability. In this study, we hypothesize that an employer-sponsored group intervention program employing self-management principles may improve worker engagement and reduce functional limitation associated with chronic disorders. In a randomized controlled trial (RCT), workers participating in an employer-sponsored self-management group intervention will be compared with a no-treatment (wait list) control condition. Volunteer employees (n = 300) will be recruited from five participating employers and randomly assigned to intervention or control. Participants in the intervention arm will attend facilitated group workshop sessions at work (10 hours total) to explore methods for improving comfort, adjusting work habits, communicating needs effectively, applying systematic problem solving, and dealing with negative thoughts and emotions about work. Work engagement and work limitation are the principal outcomes. Secondary outcomes include fatigue, job satisfaction, self-efficacy, turnover intention, sickness absence, and health care utilization. Measurements will be taken at baseline, 6-, and 12-month follow-up. A process evaluation will be performed alongside the randomized trial. This study will be most relevant for organizations and occupational settings where some degree of job flexibility, leeway, and decision-making autonomy can be afforded to affected workers. The study design will provide initial assessment of a novel workplace approach and to understand factors affecting its feasibility and effectiveness

MiDAS ENCORE: Randomized Controlled Study Design and Protocol.

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Benyamin, Ramsin M; Staats, Peter S

2015-01-01

Epidural steroid injections (ESIs) are commonly used for treatment of symptomatic lumbar spinal stenosis (LSS). ESIs are generally administered after failure of conservative therapy. For LSS patients suffering from neurogenic claudication, the mild® procedure provides an alternative to ESIs via minimally invasive lumbar decompression. Both ESIs and mild offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. Prospective, multi-center, randomized controlled, clinical study. Twenty-six interventional pain management centers throughout the United States. To compare patient outcomes following treatment with either mild or ESIs in LSS patients with neurogenic claudication and having verified ligamentum flavum hypertrophy. Study participants include Medicare beneficiaries who meet study inclusion/exclusion criteria. Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment arms, mild (treatment group) or ESI (control group). Each study group will include approximately 150 patients who have experienced neurogenic claudication symptoms for ≥ 3 months duration who have failed to respond to physical therapy, home exercise programs, and oral analgesics. Those randomized to mild are prohibited from receiving lumbar ESIs during the study period, while those randomized to ESI may receive ESIs up to 4 times per year. Patient assessments will occur at baseline, 6 months, and one year. An additional assessment will be conducted for the mild patient group at 2 years. The primary efficacy outcome measure is the proportion of Oswestry Disability Index (ODI) responders from baseline to one year follow-up in the treatment group (mild) versus the control group (ESI). ODI responders are defined as those patients achieving the validated Minimal Important Change (MIC) of ≥ 10 point improvement in ODI from baseline to follow-up as a clinically significant efficacy threshold. Secondary

Cognitive Therapy and Task Concentration Training Applied as Intensified Group Therapies for Social Anxiety Disorder with Fear of Blushing-A Randomized Controlled Trial.

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Härtling, Samia; Klotsche, Jens; Heinrich, Anke; Hoyer, Jürgen

2016-11-01

The current study examines the efficacy of intensified group therapy for social anxiety disorder with fear of blushing. Task concentration training (TCT) and cognitive therapy (CT) were applied during one weekend and compared with a waiting list condition in a randomized controlled trial including 82 patients. On a second weekend, another intervention was added (resulting in TCT-CT and CT-TCT sequences) to examine order effects. Task concentration training and CT were both superior to the waiting list and equally effective after the first therapy weekend. Also, no differences were found between the sequences TCT-CT and CT-TCT at post-assessment. At 6- and 12-month follow-up, effects remained stable or further improved. At the 6-month follow-up, remission rates in completers, established by diagnostic status, were between 69% and 73%. Intensified group therapy is highly effective in treating social anxiety disorder with fear of blushing. Group formats for patients sharing a common primary concern may contribute to the dissemination of cognitive-behavioural therapy. Copyright © 2015 John Wiley & Sons, Ltd. Key Practitioner Message: This study focuses on blushing from fearful individuals within the SAD spectrum to improve evidence for treatment efficacy in those whose social fears are centred around observable bodily sensations. This study integrates task concentration training into the SAD model of Clark and Wells to combine two evidence-based treatments for SAD under one treatment model. This study uses an innovative format of brief, intensified group therapy, conducted on two full-day weekend group sessions delivered over two weekends, with strong observed effect sizes. Copyright © 2015 John Wiley & Sons, Ltd.

Effectiveness of school dental screening on stimulating dental attendance rates in Vikarabad town: A randomized controlled trial

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Gadde Praveen

2014-01-01

Full Text Available Background: The school dental screening program has been in existence from the beginning of 20 th century. Its value in encouraging attendance among school children is not fully established. Aim: The aim was to determine the effectiveness of school dental screening on stimulating dental attendance rates among school children in Vikarabad town. Objectives: (a To compare the dental attendance rates between 6-9 and 10-13 years old age groups, among male and female school children in Vikarabad town. (b To identify the type of dental treatment received by the school children. Materials and Methods: A randomized controlled trial was conducted among school children aged 6-13 years old from 16 schools that were randomly selected and divided into two groups. Eight schools had a dental screening program (study group = 300 children and had blanket referral cards and 8 schools that did not have the intervention (control group = 300. The dental attendance rates were determined after 3 months of follow-up period by evaluating the blanket referral cards for the study group and by an oral questionnaire for the control group. Results: The dental attendance rate was 27% for the study group and 18% for the control group which is statistically significant. The attendance rate was higher among 10-13 years of children both in test group and control groups. Among the children who visited the dentist, 53% in the control group and 69% from the test group got simple amalgam and glass ionomer cement restorations. Conclusion: The dental attendance rates were improved following school dental screening.

Single Layered Versus Double Layered Intestinal Anastomosis: A Randomized Controlled Trial

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Mohapatra, Vandana; Singh, Surendra; Rath, Pratap Kumar; Behera, Tapas Ranjan

2017-01-01

Introduction Gastrointestinal anastomosis is one of the most common procedures being performed in oesophagogastric, hepatobiliary, bariatric, small bowel and colorectal surgery; however, the safety and efficacy of single layer or double layer anastomotic technique is still unclear. Aim To assess and compare the efficacy, safety and cost effectiveness of single layered versus double layered intestinal anastomosis. Materials and Methods This prospective, double-blind, randomized controlled comparative study comprised of patients who underwent intestinal resection and anastomosis. They were randomly assigned to undergo either single layered extra-mucosal anastomosis (Group-A) or double layered intestinal anastomosis (Group-B). Primary outcome measures included average time taken for anastomosis, postoperative complications, mean duration of hospital stay and cost of suture material used; secondary outcome measures assessed the postoperative return of bowel function. Statistical analysis was done by Chi-square test and student t-test. Results A total of 97 participants were randomized. Fifty patients were allocated to single layered extramucosal continuous anastomosis (Group-A) and 47 patients to double layered anastomosis (Group-B). The patients in each group were well matched for age, sex and diagnosis. The mean time taken for anastomosis (15.12±2.27 minutes in Group-A versus 24.38±2.26 minutes in Group-B) and the length of hospital stay (5.90±1.43 days in Group-A versus 7.29±1.89 days in Group-B) was significantly shorter in Group-A {p-value anastomosis. However, there was no significant difference in the complication rates between the two groups. Conclusion It can be concluded that single layered extramucosal continuous intestinal anastomosis is equally safe and perhaps more cost effective than the conventional double layered method and may represent the optimal choice for routine surgical practice. PMID:28764239

Randomized, Double-Blind, and Placebo-Controlled Clinic Report of Intranasal Low-Intensity Laser Therapy on Vascular Diseases

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Timon Cheng-Yi Liu

2012-01-01

Full Text Available The intranasal low intensity GaInP/AlGaInP diode 650 nm laser therapy (ILGLT might improve blood lipid and hemorheologic behavior of patients in view of its previous research, but it should be further supported by a randomized, double-blind, and placebo-controlled clinical study. In this paper, 90 patients with coronary heart disease or cerebral infarction were randomly divided into two groups, 60 in the treatment group and 30 in the control group, and were blindly treated with ILGLT at 8.38 and 0 mW/cm2 for 30 min each time once a day ten days each session for two sessions between which there were three days for rest, respectively. Fasting blood lipid such as total cholesterol and low/high-density lipoprotein cholesterol and hemorheologic behavior such as blood viscosity, plasma viscosity, redox viscosity and red blood cell aggregation were assessed before the first treatment and after the two sessions and were found to be significantly improved by ILGLT. It was concluded that ILGLT may improve blood lipid and hemorheologic behavior of patients with coronary heart disease or cerebral infarction.

Comparative evaluation of effectiveness between Aloe vera and two commercially available mouth rinses on plaque and gingival status: A randomized control trial

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Sujal Parkar

2011-01-01

Full Text Available Aim: Aloe vera has been suggested for a wide variety of ailments, but its use in dentistry is limited. The purpose of the study was to evaluate the effect of A. vera on the reduction of plaque and gingivitis. This effect was evaluated by randomized, parallel and double-blind clinical trial. Materials and Methods: Total 30 subjects were randomly allocated into three groups; 10 in each for (i chlorhexidine, (ii tea tree leaves and (iii A. vera. Plaque index and gingival index were assessed at days 0 and 21. Subjects were asked to rinse their mouth with the mouth rinse, twice a day, during a 21-day period. Paired t-test was used test the mean difference at 0 day and 21 days. One way analysis of variance was used to check the mean difference among three mouth rinses. Results: All three mouth rinses shows a significant reduction from 0 day to 21 days (P 0.05. Conclusion: A. vera mouth rinse was as effective as two commercially popular mouth rinses in controlling plaque and gingivitis.

Assessing the Effectiveness of Case-Based Collaborative Learning via Randomized Controlled Trial.

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Krupat, Edward; Richards, Jeremy B; Sullivan, Amy M; Fleenor, Thomas J; Schwartzstein, Richard M

2016-05-01

Case-based collaborative learning (CBCL) is a novel small-group approach that borrows from team-based learning principles and incorporates elements of problem-based learning (PBL) and case-based learning. CBCL includes a preclass readiness assurance process and case-based in-class activities in which students respond to focused, open-ended questions individually, discuss their answers in groups of 4, and then reach consensus in larger groups of 16. This study introduces CBCL and assesses its effectiveness in one course at Harvard Medical School. In a 2013 randomized controlled trial, 64 medical and dental student volunteers were assigned randomly to one of four 8-person PBL tutorial groups (control; n = 32) or one of two 16-person CBCL tutorial groups (experimental condition; n = 32) as part of a required first-year physiology course. Outcomes for the PBL and CBCL groups were compared using final exam scores, student responses to a postcourse survey, and behavioral coding of portions of video-recorded class sessions. Overall, the course final exam scores for CBCL and PBL students were not significantly different. However, CBCL students whose mean exam performance in prior courses was below the participant median scored significantly higher than their PBL counterparts on the physiology course final exam. The most common adjectives students used to describe CBCL were "engaging," "fun," and "thought-provoking." Coding of observed behaviors indicated that individual affect was significantly higher in the CBCL groups than in the PBL groups. CBCL is a viable, engaging, active learning method. It may particularly benefit students with lower academic performance.

Prone position as prevention of lung injury in comatose patients: a prospective, randomized, controlled study.

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Beuret, Pascal; Carton, Marie-Jose; Nourdine, Karim; Kaaki, Mahmoud; Tramoni, Gerard; Ducreux, Jean-Claude

2002-05-01

Comatose patients frequently exhibit pulmonary function worsening, especially in cases of pulmonary infection. It appears to have a deleterious effect on neurologic outcome. We therefore conducted a randomized trial to determine whether daily prone positioning would prevent lung worsening in these patients. Prospective, randomized, controlled study. Sixteen-bed intensive care unit. Fifty-one patients who required invasive mechanical ventilation because of coma with Glascow coma scores of 9 or less. In the prone position (PP) group: prone positioning for 4 h once daily until the patients could get up to sit in an armchair; in the supine position (SP) group: supine positioning. The primary end point was the incidence of lung worsening defined by an increase in the Lung Injury Score of at least 1 point since the time of randomization. The secondary end point was the incidence of ventilator-associated pneumonia (VAP). A total of 25 patients were randomly assigned to the PP group and 26 patients to the SP group. The characteristics of the patients from the two groups were similar at randomization. The incidence of lung worsening was lower in the PP group (12%) than in the SP group (50%) ( p=0.003). The incidence of VAP was 20% in the PP group and 38.4% in the SP group ( p=0.14). There was no serious complication attributable to prone positioning, however, there was a significant increase of intracranial pressure in the PP. In a selected population of comatose ventilated patients, daily prone positioning reduced the incidence of lung worsening.

A prospective randomized controlled trial of the two-window technique without membrane versus the solo-window technique with membrane over the osteotomy window for maxillary sinus augmentation.

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Yu, Huajie; He, Danqing; Qiu, Lixin

2017-12-01

Maturation of the grafted volume after lateral sinus elevation is crucial for the long-term survival of dental implants. To compare endo-sinus histomorphometric bone formation between the solo- and two-window maxillary sinus augmentation techniques with or without membrane coverage for the rehabilitation of multiple missing posterior teeth. Patients with severely atrophic posterior maxillae were randomized to receive lateral sinus floor elevation via the solo-window technique with membrane coverage (Control Group) or the two-window technique without coverage (Test Group). Six months after surgery, bone core specimens harvested from the lateral aspect were histomorphometrically analyzed. Ten patients in each group underwent 21 maxillary sinus augmentations. Histomorphometric analysis revealed mean newly formed bone values of 26.08 ± 16.23% and 27.14 ± 18.11%, mean connective tissue values of 59.34 ± 12.42% and 50.03 ± 17.13%, and mean residual graft material values of 14.6 ± 14.56% and 22.78 ± 10.83% in the Test and Control Groups, respectively, with no significant differences. The two-window technique obtained comparative maturation of the grafted volume even without membrane coverage, and is a viable alternative for the rehabilitation of severely atrophic posterior maxillae with multiple missing posterior teeth. © 2017 Wiley Periodicals, Inc.

Effectiveness of acupuncture therapy as treatment for tinnitus: a randomized controlled trial

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Marcelo Yugi Doi

Full Text Available ABSTRACT INTRODUCTION: Tinnitus is a subjective sensation of hearing a sound in the absence of an external stimulus, which significantly worsens the quality of life in 15-25% of affected individuals. OBJECTIVE: To assess the effectiveness of acupuncture therapy for tinnitus. METHODS: Randomized clinical trial (REBEC: 2T9T7Q with 50 participants with tinnitus, divided into two groups: 25 participants in the acupuncture group and 25 participants in the control group. The acupuncture group received acupuncture treatment and the control group received no treatment. After a period of 5 weeks, they were called to perform the final evaluation and the control group received acupuncture treatment for ethical reasons. RESULTS: A statistically significant result was found for the primary outcome, reducing the intensity of tinnitus, with p = 0.0001 and the secondary endpoint, showing improvement in quality of life, with p = 0.0001. CONCLUSION: Chinese scalp acupuncture associated with bilateral electroacupuncture demonstrated, in the short term, a statistically significant improvement by reducing the level of tinnitus intensity, as well as improving the quality of life of individuals with tinnitus.

Effectiveness of acupuncture therapy as treatment for tinnitus: a randomized controlled trial.

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Doi, Marcelo Yugi; Tano, Simone Sayomi; Schultz, Adriane Rocha; Borges, Ricardo; Marchiori, Luciana Lozza de Moraes

2016-01-01

Tinnitus is a subjective sensation of hearing a sound in the absence of an external stimulus, which significantly worsens the quality of life in 15-25% of affected individuals. To assess the effectiveness of acupuncture therapy for tinnitus. Randomized clinical trial ( 2T9T7Q) with 50 participants with tinnitus, divided into two groups: 25 participants in the acupuncture group and 25 participants in the control group. The acupuncture group received acupuncture treatment and the control group received no treatment. After a period of 5 weeks, they were called to perform the final evaluation and the control group received acupuncture treatment for ethical reasons. A statistically significant result was found for the primary outcome, reducing the intensity of tinnitus, with p=0.0001 and the secondary endpoint, showing improvement in quality of life, with p=0.0001. Chinese scalp acupuncture associated with bilateral electroacupuncture demonstrated, in the short term, a statistically significant improvement by reducing the level of tinnitus intensity, as well as improving the quality of life of individuals with tinnitus. Copyright © 2016 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

Virtual reality exercise improves mobility after stroke: an inpatient randomized controlled trial.

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McEwen, Daniel; Taillon-Hobson, Anne; Bilodeau, Martin; Sveistrup, Heidi; Finestone, Hillel

2014-06-01

Exercise using virtual reality (VR) has improved balance in adults with traumatic brain injury and community-dwelling older adults. Rigorous randomized studies regarding its efficacy, safety, and applicability with individuals after stroke are lacking. The purpose of this study was to determine whether an adjunct VR therapy improves balance, mobility, and gait in stroke rehabilitation inpatients. A blinded randomized controlled trial studying 59 stroke survivors on an inpatient stroke rehabilitation unit was performed. The treatment group (n=30) received standard stroke rehabilitation therapy plus a program of VR exercises that challenged balance (eg, soccer goaltending, snowboarding) performed while standing. The control group (n=29) received standard stroke rehabilitation therapy plus exposure to identical VR environments but whose games did not challenge balance (performed in sitting). VR training consisted of 10 to 12 thirty-minute daily sessions for a 3-week period. Objective outcome measures of balance and mobility were assessed before, immediately after, and 1 month after training. Confidence intervals and effect sizes favored the treatment group on the Timed Up and Go and the Two-Minute Walk Test, with both groups meeting minimal clinical important differences after training. More individuals in the treatment group than in the control group showed reduced impairment in the lower extremity as measured by the Chedoke McMaster Leg domain (P=0.04) immediately after training. This VR exercise intervention for inpatient stroke rehabilitation improved mobility-related outcomes. Future studies could include nonambulatory participants as well as the implementation strategies for the clinical use of VR. http://www.ANZCTR.org.au/. Unique identifier: ACTRN12613000710729. © 2014 American Heart Association, Inc.

Random Assignment of Schools to Groups in the Drug Resistance Strategies Rural Project: Some New Methodological Twists

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Pettigrew, Jonathan; Miller-Day, Michelle; Krieger, Janice L.; Zhou, Jiangxiu; Hecht, Michael L.

2014-01-01

Random assignment to groups is the foundation for scientifically rigorous clinical trials. But assignment is challenging in group randomized trials when only a few units (schools) are assigned to each condition. In the DRSR project, we assigned 39 rural Pennsylvania and Ohio schools to three conditions (rural, classic, control). But even with 13 schools per condition, achieving pretest equivalence on important variables is not guaranteed. We collected data on six important school-level variables: rurality, number of grades in the school, enrollment per grade, percent white, percent receiving free/assisted lunch, and test scores. Key to our procedure was the inclusion of school-level drug use data, available for a subset of the schools. Also, key was that we handled the partial data with modern missing data techniques. We chose to create one composite stratifying variable based on the seven school-level variables available. Principal components analysis with the seven variables yielded two factors, which were averaged to form the composite inflate-suppress (CIS) score which was the basis of stratification. The CIS score was broken into three strata within each state; schools were assigned at random to the three program conditions from within each stratum, within each state. Results showed that program group membership was unrelated to the CIS score, the two factors making up the CIS score, and the seven items making up the factors. Program group membership was not significantly related to pretest measures of drug use (alcohol, cigarettes, marijuana, chewing tobacco; smallest p>.15), thus verifying that pretest equivalence was achieved. PMID:23722619

Effectiveness of herbal and nonherbal fluoridated toothpaste on plaque and gingivitis: A randomized controlled trial

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Roopali Gupta

2015-01-01

Full Text Available Introduction: Dental plaque is a well-known etiologic factor for gingivitis. Ayurvedic drugs have been used since ancient times to treat diseases including periodontal diseases. Toothpastes made from herbal medicines are used in periodontal therapy to control bleeding and reduce inflammation. Aim: To compare the effectiveness of herbal and nonherbal fluoridated toothpaste on plaque and gingivitis among residents of ladies hostel in Mathura City. Materials and Methods: A randomized controlled clinical trial was carried out on 60 participants aged 18-30 years residing in a ladies hostel of Mathura City. The 60 participants were randomly allocated into two groups: Group-I: Experimental group using herbal toothpaste, Group-II: Control group using fluoridated toothpaste. The subjects were asked to brush twice daily with the assigned dentifrice using standardized brushing technique for 46 days. The plaque and gingival indices were recorded according to Silness and Loe (1964 and Loe and Silness (1963, respectively. These parameters were assessed at baseline, 3 weeks, and 6 weeks. Data were analyzed by Student paired t-test and unpaired t-test using Statistical Package for the Social Sciences version 21 manufactured by IBM Corporation - Armonk, New York, US. Results: Baseline plaque and gingival scores were found 1.02 ± 0.02 and 0.88 ± 0.06 for the experimental group and 1.02 ± 0.03 and 0.81 ± 0.08 for control group, respectively. After 6 weeks plaque and gingival scores were found 0.77 ± 0.07 and 0.72 ± 0.08 for experimental group and 0.78 ± 0.07 and 0.73 ± 0.11 for control group, respectively. Statistically significant differences were obtained before and after intervention in both groups (P ≤ 0.05. Conclusion: The herbal toothpaste was as effective as the conventionally formulated fluoride dentifrice in controlling plaque and gingivitis.

A randomized clinical study of two interceptive approaches to palatally displaced canines.

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Baccetti, Tiziano; Leonardi, Maria; Armi, Pamela

2008-08-01

This study evaluated the effectiveness of two interceptive approaches to palatally displaced canines (PDC), i.e. extraction of the primary canines alone or in association with the use of a cervical-pull headgear. The randomized prospective design comprised 75 subjects with PDC (92 maxillary canines) who were randomly assigned to three groups: extraction of the primary canine only (EG), extraction of the primary canine and cervical-pull headgear (EHG), and an untreated control group (CG). Panoramic radiographs were evaluated at the time of initial observation (T1) and after an average period of 18 months (T2). At T2, an evaluation of the success of canine eruption was undertaken. Between-group statistical comparisons, Kruskal-Wallis test with Bonferroni correction, were performed on the T1-T2 changes of the diagnostic parameters on panoramic radiographs and the prevalence rates of success in canine eruption. A superimposition study on lateral cephalograms at T1 and T2 was carried out to evaluate the changes in the sagittal position of the upper molars in the three groups. The removal of the primary canine as an isolated measure to intercept palatal displacement of maxillary canines showed a success rate of 65.2 per cent, which was significantly greater than that in the untreated controls (36 per cent). The additional use of a headgear resulted in successful eruption in 87.5 per cent of the subjects, with a significant improvement in the measurements for intraosseous canine position. The cephalometric superimposition study showed a significant mesial movement of the upper first molars in the CG and EG when compared with the EHG.

Flunarizine in the prophylaxis of migrainous vertigo: a randomized controlled trial.

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Lepcha, Anjali; Amalanathan, Sophia; Augustine, Ann Mary; Tyagi, Amit Kumar; Balraj, Achamma

2014-11-01

Migrainous vertigo is a common cause of dizziness presenting to an otorhinolaryngology/otoneurology clinic. Although it causes a substantial burden to the individual and society there are no randomized controlled trails on prophylactic medication for this condition. Flunarizine, a calcium channel blocker has been used effectively in both migraine and vestibular conditions. This randomized control trial was undertaken in a tertiary academic referral center to evaluate the efficacy of flunarizine in patients with migrainous vertigo when compared to non-specific vestibular treatment of betahistine and vestibular exercises. The effect of flunarizine on two particularly disabling symptoms of vertigo and headache was studied. A total of 48 patients who were diagnosed with definitive migrainous vertigo completed the study of 12 weeks duration. Patients in arm A received 10-mg flunarizine daily along with betahistine 16 mg and paracetamol 1 gm during episodes, and arm B received only betahistine and paracetamol during episodes. Symptom scores were noted at the start of the study and at the end of 12 weeks. Analysis of the frequency of vertiginous episodes showed a significant difference between arm A and arm B (p = 0.010) and improvement in severity of vertigo between the two groups (p = 0.046). Headache frequency and severity did not improve to a significant degree in arm A as compared to arm B. The main side effects were weight gain and somnolence and this was not significantly different between the two groups. Flunarizine (10 mg) is effective in patients with migrainous vertigo who suffer from considerable vestibular symptoms.

Completion report : Effect of Comprehensive Yogic Breathing program on type 2 diabetes: A randomized control trial

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V P Jyotsna

2014-01-01

Full Text Available Background: Yoga has been shown to be benefi cial in diabetes in many studies, though randomized control trials are few. The aim of this randomized control trial was to see the effect of Sudarshan Kriya and related practices (comprehensive yogic breathing program on quality of life, glycemic control, and cardiac autonomic functions in diabetes. Diabetes mellitus is a risk factor for sudden cardiac death. Cardiac autonomic neuropathy has been implicated in the causation of sudden cardiac death. Therefore, a maneuver to prevent progression of cardiac autonomic neuropathy holds signifi cance. Materials and Methods: A total of 120 patients of diabetes on oral medication and diet and exercise advice were randomized into two groups: (1 Continued to receive standard treatment for diabetes. (2 Patients administered comprehensive yogic breathing program and monitored to regularly practice yoga in addition to standard treatment of diabetes. At 6 months, quality of life and postprandial plasma glucose signifi cantly improved in the group practicing yoga compared to baseline, but there was no significant improvement in the fasting plasma glucose and glycated hemoglobin. Results: On per protocol analysis, sympathetic cardiac autonomic functions signifi cantly improved from baseline in the group practicing comprehensive yogic breathing. Conclusion: This randomized control trial points towards the beneficial effect of yogic breathing program in preventing progression of cardiac neuropathy. This has important implications as cardiac autonomic neuropathy has been considered as one of the factors for sudden cardiac deaths.Keywords: comprehensive yogic breathing program, diabetes mellitus, cardiac autonomic function

Treatment for symptomatic bacterial vaginosis: a randomized controlled trial

International Nuclear Information System (INIS)

Tariq, N.; Basharat, A.; Fahim, A.

2017-01-01

Objective: To compare the efficacy of multiple doses of vaginal clindamycin with a single oral dose of secnidazole for the treatment of bacterial vaginosis. Study Design: Double-blinded randomized controlled trial. Place and Duration of Study: Shifa Foundation Community Health Center, from March 2012 till February 2015. Methodology: After obtaining written informed consent, a pelvic examination was performed for the confirmation of symptoms of milky white vaginal discharge on speculum examination, positive Amine test and presence of clue cells on microscopy. Pregnant women, known diabetes or any immunocompromised condition, were excluded. Blinding of the patient, doctor, and the pharmacist was done. Study cohort was then divided into two groups, Group A received medicine pack A which contained active clindamycin and placebo oral preparation, whereas group B was given pack B which contained active 2-gm secnidazole with placebo vaginal cream. Primary outcome and therapeutic success were defined by correction of two out of three (normal Nugent score, negative Amine test, and no milky white discharge) on day 15. Results: At 15th day of treatment, 96.6% participants in vaginal clindamycin group (Group A), recovered from the bacterial vaginosis; whereas, (group B) 23% patients were cured in oral secnidazole group. Conclusion: Multiple doses of vaginal clindamycin are superior to single dose of oral secnidazole for the treatment of bacterial vaginosis. (author)

The ACTIVATE study: results from a group-randomized controlled trial comparing a traditional worksite health promotion program with an activated consumer program.

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Terry, Paul E; Fowles, Jinnet Briggs; Xi, Min; Harvey, Lisa

2011-01-01

PURPOSE. This study compares a traditional worksite-based health promotion program with an activated consumer program and a control program DESIGN. Group randomized controlled trial with 18-month intervention. SETTING. Two large Midwestern companies. SUBJECTS. Three hundred and twenty employees (51% response). INTERVENTION. The traditional health promotion intervention offered population-level campaigns on physical activity, nutrition, and stress management. The activated consumer intervention included population-level campaigns for evaluating health information, choosing a health benefits plan, and understanding the risks of not taking medications as prescribed. The personal development intervention (control group) offered information on hobbies. The interventions also offered individual-level coaching for high risk individuals in both active intervention groups. MEASURES. Health risk status, general health status, consumer activation, productivity, and the ability to evaluate health information. ANALYSIS. Multivariate analyses controlled for baseline differences among the study groups. RESULTS. At the population level, compared with baseline performance, the traditional health promotion intervention improved health risk status, consumer activation, and the ability to recognize reliable health websites. Compared with baseline performance, the activated consumer intervention improved consumer activation, productivity, and the ability to recognize reliable health websites. At the population level, however, only the activated consumer intervention improved any outcome more than the control group did; that outcome was consumer activation. At the individual level for high risk individuals, both traditional health coaching and activated consumer coaching positively affected health risk status and consumer activation. In addition, both coaching interventions improved participant ability to recognize a reliable health website. Consumer activation coaching also

Cognitive behaviour therapy for violent men with antisocial personality disorder in the community: an exploratory randomized controlled trial.

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Davidson, K M; Tyrer, P; Tata, P; Cooke, D; Gumley, A; Ford, I; Walker, A; Bezlyak, V; Seivewright, H; Robertson, H; Crawford, M J

2009-04-01

Little information exists on treatment effectiveness in antisocial personality disorder (ASPD). We investigated the feasibility and effectiveness of carrying out a randomized controlled trial of cognitive behaviour therapy (CBT) in men with ASPD who were aggressive. This was an exploratory two-centre, randomized controlled trial in a community setting. Fifty-two adult men with a diagnosis of ASPD, with acts of aggression in the 6 months prior to the study, were randomized to either treatment as usual (TAU) plus CBT, or usual treatment alone. Change over 12 months of follow-up was assessed in the occurrence of any act of aggression and also in terms of alcohol misuse, mental state, beliefs and social functioning. The follow-up rate was 79%. At 12 months, both groups reported a decrease in the occurrence of any acts of verbal or physical aggression. Trends in the data, in favour of CBT, were noted for problematic drinking, social functioning and beliefs about others. CBT did not improve outcomes more than usual treatment for men with ASPD who are aggressive and living in the community in this exploratory study. However, the data suggest that a larger study is required to fully assess the effectiveness of CBT in reducing aggression, alcohol misuse and improving social functioning and view of others. It is feasible to carry out a rigorous randomized controlled trial in this group.

Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention.

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Brendryen, Håvar; Kraft, Pål

2008-03-01

To assess the long-term efficacy of a fully automated digital multi-media smoking cessation intervention. Two-arm randomized control trial (RCT). Setting World Wide Web (WWW) study based in Norway. Subjects (n = 396) were recruited via internet advertisements and assigned randomly to conditions. Inclusion criteria were willingness to quit smoking and being aged 18 years or older. The treatment group received the internet- and cell-phone-based Happy Ending intervention. The intervention programme lasted 54 weeks and consisted of more than 400 contacts by e-mail, web-pages, interactive voice response (IVR) and short message service (SMS) technology. The control group received a self-help booklet. Additionally, both groups were offered free nicotine replacement therapy (NRT). Abstinence was defined as 'not even a puff of smoke, for the last 7 days', and assessed by means of internet surveys or telephone interviews. The main outcome was repeated point abstinence at 1, 3, 6 and 12 months following cessation. Participants in the treatment group reported clinically and statistically significantly higher repeated point abstinence rates than control participants [22.3% versus 13.1%; odds ratio (OR) = 1.91, 95% confidence interval (CI): 1.12-3.26, P = 0.02; intent-to-treat). Improved adherence to NRT and a higher level of post-cessation self-efficacy were observed in the treatment group compared with the control group. As the first RCT documenting the long-term treatment effects of such an intervention, this study adds to the promise of digital media in supporting behaviour change.

Effect of providing free glasses on children's educational outcomes in China: cluster randomized controlled trial.

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Ma, Xiaochen; Zhou, Zhongqiang; Yi, Hongmei; Pang, Xiaopeng; Shi, Yaojiang; Chen, Qianyun; Meltzer, Mirjam E; le Cessie, Saskia; He, Mingguang; Rozelle, Scott; Liu, Yizhi; Congdon, Nathan

2014-09-23

To assess the effect of provision of free glasses on academic performance in rural Chinese children with myopia. Cluster randomized, investigator masked, controlled trial. 252 primary schools in two prefectures in western China, 2012-13. 3177 of 19,934 children in fourth and fifth grades (mean age 10.5 years) with visual acuity 6/12 with glasses. 3052 (96.0%) completed the study. Children were randomized by school (84 schools per arm) to one of three interventions at the beginning of the school year: prescription for glasses only (control group), vouchers for free glasses at a local facility, or free glasses provided in class. Spectacle wear at endline examination and end of year score on a specially designed mathematics test, adjusted for baseline score and expressed in standard deviations. Among 3177 eligible children, 1036 (32.6%) were randomized to control, 988 (31.1%) to vouchers, and 1153 (36.3%) to free glasses in class. All eligible children would benefit from glasses, but only 15% wore them at baseline. At closeout glasses wear was 41% (observed) and 68% (self reported) in the free glasses group, and 26% (observed) and 37% (self reported) in the controls. Effect on test score was 0.11 SD (95% confidence interval 0.01 to 0.21) when the free glasses group was compared with the control group. The adjusted effect of providing free glasses (0.10, 0.002 to 0.19) was greater than parental education (0.03, -0.04 to 0.09) or family wealth (0.01, -0.06 to 0.08). This difference between groups was significant, but was smaller than the prespecified 0.20 SD difference that the study was powered to detect. The provision of free glasses to Chinese children with myopia improves children's performance on mathematics testing to a statistically significant degree, despite imperfect compliance, although the observed difference between groups was smaller than the study was originally designed to detect. Myopia is common and rarely corrected in this setting.Trial Registration

Effectiveness of Wii-based rehabilitation in stroke: A randomized controlled study

OpenAIRE

Ayça Utkan Karasu; Elif Balevi Batur; Gülçin Kaymak Karataş

2018-01-01

Objective: To investigate the efficacy of Nintendo Wii Fit®-based balance rehabilitation as an adjunc-tive therapy to conventional rehabilitation in stroke patients. Methods: During the study period, 70 stroke patients were evaluated. Of these, 23 who met the study criteria were randomly assigned to either the experimental group (n = 12) or the control group (n = 11) by block randomization. Primary outcome measures were Berg Balance Scale, Functional Reach Test, Postural Asses...

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

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Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; DE Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick

2017-12-01

Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Male fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.

CoCo trial: Color-coded blood pressure Control, a randomized controlled study

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