Dataset Information

Prevention of striae gravidarum: study protocol for a pilot randomised controlled trial.

ABSTRACT: BACKGROUND:Striae gravidarum (stretch marks) are considered the most common connective tissue/skin change in pregnancy. Though not a health issue they can affect women in different ways, for example, cause stress or be an aesthetic or cosmetic concern. Many women use one or more of the commercially available products to try and prevent their development during pregnancy despite the fact that that there is a lack of high-quality evidence to support their use. There is a dearth of studies on the prevention of striae gravidarum and large, robust trials are lacking. Until such time as more products are investigated, much of the knowledge remains anecdotal. This pilot study will evaluate the feasibility of conducting a study to evaluate the effectiveness of a commercially available moisturising oil compared to no treatment for the prevention and reduction in severity of striae gravidarum. METHODS:The definitive study will be a randomised controlled trial to evaluate the effectiveness of a moisturising oil (commercially available moisturising oil) compared to no treatment for the prevention and reduction in severity of striae gravidarum. This protocol is for a pilot randomised trial to evaluate the feasibility of conducting such a study. The pilot study will be a two-arm, unblinded, pragmatic parallel randomised trial with a 1:1 randomisation ratio between control and intervention groups. Women in the intervention group will be asked to apply a moisturising oil to their abdomen during pregnancy, while women in the control group will not use any treatment. It is proposed to recruit 20 primigravida, who are 12-16 weeks pregnant from an Irish Maternity Hospital, in each arm to assess the feasibility of running such a trial. DISCUSSION:This pilot trial will evaluate the feasibility of conducting the main study to evaluate the effectiveness of a moisturising oil (commercially available moisturising oil) compared to no treatment for the prevention and reduction in severity of striae gravidarum. It will potentially initiate the generation of high-quality evidence to guide women in their choice of anti-stretch mark product. TRIAL REGISTRATION:ISRCTN Registry, ISRCTN76992326 . Registered on 14 July 2017.

SUBMITTER: Brennan M

PROVIDER: S-EPMC6186113 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Prevention of striae gravidarum: study protocol for a pilot randomised controlled trial.

Brennan Miriam M Clarke Mike M Newell John J Devane Declan D

Trials 20181012 1

<h4>Background</h4>Striae gravidarum (stretch marks) are considered the most common connective tissue/skin change in pregnancy. Though not a health issue they can affect women in different ways, for example, cause stress or be an aesthetic or cosmetic concern. Many women use one or more of the commercially available products to try and prevent their development during pregnancy despite the fact that that there is a lack of high-quality evidence to support their use. There is a dearth of studies ...[more]

PMID: 30314504

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Project description:IntroductionStroke is a globally common disease that has detrimental effects on the individual and, more broadly, on society. Lifestyle change can contribute to reducing risk factors for stroke. Although a healthy lifestyle has direct benefits, sustaining and incorporating healthy activities into everyday life is a challenge. Engaging everyday activities have the potential to support lifestyle change and to promote sustainable activity patterns. Current healthcare is failing to reduce modifiable risk factors in people at risk, and in addition to current practice, there is a need for systematic and efficient non-pharmacological and non-surgical stroke-prevention strategies. The aim of the pilot study was to increase knowledge about the effects of a prevention programme and its feasibility to promote sustainable and healthy activity patterns among persons at risk of stroke.Methods and analysisThe proposed pilot study will be a two-armed randomised, assessor-blinded, parallel pilot trial. The study will include feasibility data, investigating acceptability and delivery of the intervention. Persons at risk of stroke (n=60) will be included in a mobile phone-supported prevention programme. The 10-week programme will be conducted at primary healthcare clinics, combining group meetings and online resources to support self-management of lifestyle change. Main outcomes are stroke risk, lifestyle habits and healthy activity patterns. Assessments will be performed at baseline and at follow-up (immediately following the end of the programme and at 6 and 12 months). Effects of the programme will be analysed using inferential statistics. Feasibility will be analysed using both qualitative and quantitative methods.Ethics and disseminationThe study has been approved by the Regional Ethical Review Board in Stockholm, Sweden, being granted reference numbers 2015/834-31, 2016/2203-32 and 2019/01444. Study results will be disseminated through peer-review journals and presentations to mixed audiences at regional and international conferences.Trial registration numberNCT03730701.

Project description:BackgroundWhile existing psychological treatments for depression are effective for many, a significant proportion of depressed individuals do not respond to current approaches and few remain well over the long-term. Anhedonia (a loss of interest or pleasure) is a core symptom of depression which predicts a poor prognosis but has been neglected by existing treatments. Augmented Depression Therapy (ADepT) has been co-designed with service users to better target anhedonia alongside other features of depression. This mixed methods pilot trial aims to establish proof of concept for ADepT and to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost-effectiveness of ADepT, compared to an evidence-based mainstream therapy (Cognitive Behavioural Therapy; CBT) in the acute treatment of depression, the prevention of subsequent depressive relapse, and the enhancement of wellbeing.MethodsWe aim to recruit 80 depressed participants and randomise them 1:1 to receive ADepT (15 weekly acute and 5 booster sessions in following year) or CBT (20 weekly acute sessions). Clinical and health economic assessments will take place at intake and at 6-, 12-, and 18-month follow-up. Reductions in PHQ-9 depression severity and increases in WEMWBS wellbeing at 6-month assessment (when acute treatment should be completed) are the co-primary outcomes. Quantitative and qualitative process evaluation will assess mechanism of action, implementation issues, and contextual moderating factors. To evaluate proof of concept, intake-post effect sizes and the proportion of individuals showing reliable and clinically significant change on outcome measures in each arm at each follow-up will be reported. To evaluate feasibility and acceptability, we will examine recruitment, retention, treatment completion, and data completeness rates and feedback from patients and therapists about their experience of study participation and therapy. Additionally, we will establish the cost of delivery of ADepT.DiscussionWe will proceed to definitive trial if any concerns about the safety, acceptability, feasibility, and proof of concept of ADepT and trial procedures can be rectified, and we recruit, retain, and collect follow-up data on at least 60% of the target sample.Trial registrationISCRTN85278228, registered 27/03/2017.

Project description:BACKGROUNDIn recent years, the number of arthroscopic shoulder surgeries has increased given that the intervention is minimally invasive. However, postoperative pain is one of the most common symptoms of patients who undergo arthroscopic surgery. Although pharmacological treatments and brachial plexus blocks for reducing pain are currently used, the adherence rate of interventions is low, and adverse effects often occur. Chimsband, made up of silver and optic fibres, is a novel taping therapy that stimulates patients' acupoints and is expected to relieve pain with few adverse effects. The aim of this study is to explore the effectiveness of Chimsband to relieve pain following arthroscopic shoulder surgery.METHODS/DESIGNThis is a randomised, parallel, controlled, exploratory clinical trial. Thirty participants who undergo arthroscopic shoulder surgery will be randomly allocated to an intervention or a control group. Both groups will receive 10 sessions of interferential current therapy within a period of 2 weeks, while the intervention group will additionally receive taping therapy after undergoing physical therapy. Two follow-up visits will be scheduled after the last treatment session. The primary outcome variable will be the difference in the visual analogue scale (VAS) scores between baseline and first follow-up evaluation after the end of 10 treatment sessions. The secondary outcomes will be VAS at the end of the second week, shoulder pain and disability index, range of motion, VAS while sleeping, questionnaire of blood stasis pattern identification at two follow-up visits, and number of bands used per visit. Outcomes will be evaluated at baseline, 2 weeks from visit 1 (+ within 6 days) after commencement, and at 4 weeks from visit 1 (+ within 6 days) follow-up.DISCUSSIONThis study will be the first clinical trial to explore the effect and safety of Chimsband on postoperative shoulder pain. It would provide clinical evidence to conduct further taping therapy studies for relieving musculoskeletal pain.TRIAL REGISTRATIONKorean Clinical Trial Registry, KCT0002355 . Registered on 13 June 2017.

Project description:INTRODUCTION:Teachers and student teachers in Germany are a high-risk population for stress and stress-related mental health problems. This often leads to early retirement in subsequent professional life. Various trials have demonstrated positive effects of stress prevention training on the perceived stress and stress-related symptoms of teachers. Although many studies show positive effects of mindfulness-based stress interventions, there is not yet any mindfulness-based intervention for teachers or student teachers in Germany. The aim of this trial is to evaluate a training that combines mindfulness-based and cognitive interventions into one programme, addressing to the specific burdens of student teachers. METHODS AND ANALYSIS:This study protocol presents a prospective block-randomised controlled trial. Assessment will take place at three time points (baseline, post-intervention, 3-month follow-up) for an intervention and waiting control group, and at a fourth assessment point for the waiting control group after receiving the training. The aim is to evaluate the effects of mindfulness-based stress prevention on stress, psychological morbidity, burnout and self-efficacy using validated measures. Participants are student teachers from German teacher training colleges and participation will be voluntary. The targeted total sample size is 96 at 3-month follow-up. The training will comprise three 4-hour sessions conducted every 2 weeks. The control group will participate in the training after the 3-month follow-up. The allotment will be randomised with a stratified allocation ratio by gender. After descriptive statistics have been evaluated, inferential statistical analysis will be conducted using repeated measures analysis of variance with interactions between time and group. Effect sizes will be calculated using partial η2 values. ETHICS AND DISSEMINATION:Results will be disseminated at conferences, in specialist magazines and through peer-reviewed publications. The trial has been approved by the ethics review board of the local medical association, Mainz, Germany, under the reference number 837.192.16 (10511). TRIAL REGISTRATION NUMBER:DRKS00010897.

Project description:Feasibility studyObjectives:Refine a bespoke enhanced support intervention (ESI) (including self-help materials, intervention manual and training) for implementation by community pharmacy (CP) staff to people with sub-threshold depression and long-term conditions (LTCs) based upon evidence-supported interventions in primary careDevelop and refine study procedures (recruitment strategies and set up, screening, participant recruitment, assessment, suitability of outcome measures and data collection procedures) for testing in the pilot study phaseDesign: A case series/qualitative studySetting: UK community pharmacyPopulation: Adults with long-term health conditions who screen-positive for depression but who do not reach the threshold for DSM IV Moderate Depressive disorderIntervention: Enhanced support intervention (ESI) delivered by an appropriately trained community pharmacy team member involving four to six sessions over four months. ESI is a modified form of an intervention within the collaborative care framework for sub-threshold depression validated in previous studies in UK primary care which appears suitable for implementation in community settings.Sample size: 20-30 participantsOutcomes: Study implementation (recruitment and attrition rates), quality of data collection at baseline and 4 months and ESI adherence (number of contacts, DNA and drop out) as per objectives 1a/bQualitative evaluation: Semi-structured interviews with up to 10 participants and ESI facilitators and focus group(s) (range of pharmacy staff n =?8-10) will be conducted to explore the acceptability of the intervention and feasibility of the study, training and study procedures.External pilot studyObjectives:Quantify the flow of participants (eligibility, recruitment and follow-up rate)Evaluate proposed recruitment, assessment and outcome measure collection methodsExamine the delivery of the enhanced support intervention in a community pharmacy setting (intervention uptake, retention and dose) to inform process evaluationProcess evaluation, using semi-structured interviews with participants across a range of socio-economic settings, and pharmacy staff to explore the acceptability of the ESI within community pharmacy, elements of the intervention that were considered useful (or not) and appropriateness of study proceduresDesign: Pilot randomised controlled trial, including a prospective economic and qualitative evaluationSetting: As abovePopulation: As aboveIntervention: As above with adaptations post feasibility studyComparator: Usual careSample size: 100 participantsOutcomes: Data will be used to estimate recruitment, intervention delivery and study completion rates as per objectives 2a-d. Definitive estimates of the effectiveness of ESI will not be made.Primary outcome: Depression severity (Patient Health Questionnaire 9) at four months.Secondary outcomes: Patient acceptance, uptake and attrition. ICD10 depression status, anxiety (GAD 7), health-related quality of life (SF-12v2) and health-state utility (EQ5D 3L) will be measured at four months.Economic evaluation: The incremental cost per QALY will be calculated from both the NHS and societal perspective.Process evaluation: Using mixed methods, potential mediators/moderators of the intervention, the acceptability (to participants and pharmacy staff), barriers and facilitators to the use of ESI in community pharmacy, and impact on usual practice will be examined. Semi-structured interviews with approximately 30 study participants, 20 pharmacy staff and eight GPs near participating pharmacies will be conducted.Trial registrationISRCTN: ISRCTN11290592Protocol version number: Version 4.1 (dated 16th January 2018)Study Sponsor Tees Esk and Wear Valleys NHS Foundation Trust.

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Dataset Information

Prevention of striae gravidarum: study protocol for a pilot randomised controlled trial.

Publications

Prevention of striae gravidarum: study protocol for a pilot randomised controlled trial.

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