scholarly journals Community-based doula support for migrant women during labour and birth: study protocol for a randomised controlled trial in Stockholm, Sweden (NCT03461640)

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e031290
Author(s):  
Erica Schytt ◽  
Anna Wahlberg ◽  
Amani Eltayb ◽  
Rhonda Small ◽  
Nataliia Tsekhmestruk ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Well Being ◽  
Ethical Review ◽  
Control Group ◽  
Migrant Women ◽  
Intrapartum Care ◽  
Community Based ◽  
Randomised Controlled

IntroductionMigrant women consistently rate their care during labour and birth more negatively than non-migrant women, due to communication difficulties, lack of familiarity with how care is provided, and discrimination and prejudicial staff attitudes. They also report being left alone, feeling fearful, unsafe and unsupported, and have poorer birth outcomes than non-migrant women. Community-based doulas (CBDs) are bilingual women from migrant communities who are trained in childbirth and labour support, and who facilitate communication between woman-partner-staff during childbirth. This study protocol describes the design, rationale and methods of a randomised controlled trial that aims to evaluate the effectiveness of CBD support for improving the intrapartum care experiences and postnatal well-being of migrant women giving birth in Sweden.Methods and analysisA randomised controlled trial. From six antenatal care clinics in Stockholm, Sweden, we aim to recruit 200 pregnant Somali, Arabic, Polish, Russian and Tigrinya-speaking women who cannot communicate fluently in Swedish, are 18 years or older and with no contraindications for vaginal birth. In addition to standard labour support, women are randomised to CBD support (n=100) or no such support during labour (n=100). Trained CBDs meet with women once or twice before the birth, provide emotional, physical and communication support to women throughout labour and birth in hospital, and then meet with women once or twice after the birth. Women’s ratings of the intrapartum care experiences and postnatal well-being are assessed at 6–8 weeks after the birth using selected questions from the Migrant Friendly Maternity Care Questionnaire and by the Edinburgh Postnatal Depression Scale. The intervention group will be compared with the control group using intention-to-treat analyses. ORs and 95% CIs will be estimated and adjustments made if key participant characteristics differ between trial arms.Ethics and disseminationThe study was approved by the Regional Ethical Review Board in Stockholm (approval number: 2018/12 - 31/2).Trial registration numberNCT03461640; Pre-results.

scholarly journals A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Vladimir Carli ◽  
Danuta Wasserman ◽  
Gergö Hadlaczky ◽  
Nuhamin Gebrewold Petros ◽  
Sara Carletto ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Physiological Data ◽  
Control Group ◽  
Evidence Based ◽  
Treatment As Usual ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Abstract Background Depressive symptoms are common in individuals suffering from severe somatic conditions. There is a lack of interventions and evidence-based interventions aiming to reduce depressive symptoms in patients with severe somatic conditions. The aim of the NEVERMIND project is to address these issues and provide evidence by testing the NEVERMIND system, designed to reduce and prevent depressive symptoms in comparison to treatment as usual. Methods The NEVERMIND study is a parallel-groups, pragmatic randomised controlled trial to assess the effectiveness of the NEVERMIND system in reducing depressive symptoms among individuals with severe somatic conditions. The NEVERMIND system comprises a smart shirt and a user interface, in the form of a mobile application. The system is a real-time decision support system, aiming to predict the severity and onset of depressive symptoms by modelling the well-being condition of patients based on physiological data, body movement, and the recurrence of social interactions. The study includes 330 patients who have a diagnosis of myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants are randomised in blocks of ten to either the NEVERMIND intervention or treatment as usual as the control group. Clinical interviews and structured questionnaires are administered at baseline, at 12 weeks, and 24 weeks to assess whether the NEVERMIND system is superior to treatment as usual. The endpoint of primary interest is Beck Depression Inventory II (BDI-II) at 12 weeks defined as (i) the severity of depressive symptoms as measured by the BDI-II. Secondary outcomes include prevention of the onset of depressive symptoms, changes in quality of life, perceived stigma, and self-efficacy. Discussion There is a lack of evidence-based interventions aiming to reduce and prevent depressive symptoms in patients with severe somatic conditions. If the NEVERMIND system is effective, it will provide healthcare systems with a novel and innovative method to attend to depressive symptoms in patients with severe somatic conditions. Trial registration DRKS00013391. Registered 23 November 2017.

scholarly journals Mindfulness-based and cognitive-based stress prevention in student teachers (startklar): study protocol of a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e021941
Author(s):  
Jasmina Eskic ◽  
Sophie Merle Kuhlmann ◽  
Katharina Kreinbihl ◽  
Florian Hammerle
Keyword(s):  
Randomised Controlled Trial ◽  
Student Teachers ◽  
Study Protocol ◽  
Controlled Trial ◽  
Control Group ◽  
High Risk Population ◽  
Stress Prevention ◽  
Positive Effects ◽  
Randomised Controlled

IntroductionTeachers 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 analysisThis 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 η2values.Ethics and disseminationResults 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 numberDRKS00010897.

scholarly journals Virtual reality for relatives of ICU patients to improve psychological sequelae: study protocol for a multicentre, randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e049704
Author(s):  
Johan H Vlake ◽  
Jasper van Bommel ◽  
Evert-Jan Wils ◽  
Tim Korevaar ◽  
Merel E Hellemons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Virtual Reality ◽  
Intensive Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Icu Patients ◽  
Randomised Controlled

IntroductionIntensive care unit (ICU) admission of a relative might lead to psychological distress and complicated grief (post-intensive care syndrome–family; PICS-F). Evidence suggests that increased distress during ICU stay increases risk of PICS-F, resulting in difficulty returning to their normal lives after the ICU experience. Effective interventions to improve PICS-F are currently lacking. In the present trial, we hypothesised that information provision using ICU-specific Virtual Reality for Family members/relatives (ICU-VR-F) may improve understanding of the ICU and subsequently improve psychological well-being and quality of life in relatives of patients admitted to the ICU.Methods and analysisThis multicentre, clustered randomised controlled trial will be conducted from January to December 2021 in the mixed medical-surgical ICUs of four hospitals in Rotterdam, the Netherlands. We aim to include adult relatives of 160 ICU patients with an expected ICU length of stay over 72 hours. Participants will be randomised clustered per patient in a 1:1 ratio to either the intervention or control group. Participants allocated to the intervention group will receive ICU-VR-F, an information video that can be watched in VR, while the control group will receive usual care. Initiation of ICU-VR-F will be during their hospital visit unless participants cannot visit the hospital due to COVID-19 regulations, then VR can be watched digitally at home. The primary objective is to study the effect of ICU-VR-F on psychological well-being and quality of life up to 6 months after the patients’ ICU discharge. The secondary outcome is the degree of understanding of ICU treatment and ICU modalities.Ethics and disseminationThe Medical Ethics Committee of the Erasmus Medical Centre, Rotterdam, the Netherlands, approved the study and local approval was obtained from each participating centre (NL73670.078.20). Our findings will be disseminated by presentation of the results at (inter)national conferences and publication in scientific, peer-reviewed journals.Trial registration numberNetherlands Trial Register (TrialRegister.nl, NL9220).

scholarly journals Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e036496 ◽  
Author(s):  
Anna Lena Brorsson ◽  
Ewa-Lena Bratt ◽  
Philip Moons ◽  
Anna Ek ◽  
Elisabeth Jelleryd ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ethical Review ◽  
Control Group ◽  
Randomised Controlled

IntroductionAdolescence is a critical period for youths with chronic conditions, when they are supposed to take over the responsibility for their health. Type 1 diabetes (T1D) is one of the most common chronic conditions in childhood and inadequate self-management increases the risk of short-term and long-term complications. There is a lack of evidence regarding the effectiveness of transition programmes. As a part of the Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS research programme, the objective of this study is to evaluate the effectiveness and experiences of different transitional care models, including a person-centred transition programme aiming to empower adolescents with T1D to become active partners in their health and care.Methods and analysisIn this randomised controlled trial, patients are recruited from two paediatric diabetes clinics at the age of 16 years. Patients are randomly assigned to either the intervention group (n=70) where they will receive usual care plus the structured transition programme, or to the control group (n=70) where they will only receive usual care. Data will be collected at 16, 17 and 18.5 years of age. In a later stage, the intervention group will be compared with adolescents in a dedicated youth clinic in a third setting. The primary outcome is patient empowerment. Secondary outcomes include generic, diabetes-specific and transfer-specific variables.Ethics and disseminationThe study has been approved by the Ethical Review Board in Stockholm (Dnr 2018/1725-31). Findings will be reported following the Consolidated Standards of Reporting Trials statement and disseminated in peer-reviewed journals and at international conferences.Trial registration numberNCT03994536

scholarly journals Effects of a mindfulness-based intervention (MYmind) for children with ADHD and their parents: protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e022514 ◽  
Author(s):  
Stanley Kam Chung Chan ◽  
Dexing Zhang ◽  
Susan M Bögels ◽  
Christian Shaunlyn Chan ◽  
Kelly Yee Ching Lai ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Parenting Styles ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Brain Regions ◽  
Control Group ◽  
Children With Adhd ◽  
Informed Consent Form ◽  
Randomised Controlled

IntroductionMindfulness is one of the potential alternative interventions for children with attention-deficit hyperactivity disorder (ADHD). Some evidence suggests that mindfulness is related to changes in brain regions associated with ADHD. The potential benefits of mindfulness on children with ADHD, as well as the feasibility of this intervention approach, are warranted through prior local and foreign studies. This study aims to evaluate the effect of mindfulness-based group intervention for children with ADHD and their respective parents through a robust research design.Methods and analysisThis study will adopt a randomised controlled trial design including 140 children aged 8–12 years with ADHD together with one of their parents (n=140). These families will be randomised into intervention group (n=70) who will be offered the MYmind programme delivered by trained healthcare professionals, and an active control group (n=70) who will be offered the CBT programme. The intervention includes 8 weekly 90 min group sessions for children with ADHD (aged 8–12 years) and their respective parents. The primary and secondary outcomes will include children’s attention, ADHD-related symptoms, behaviours, executive function and mindfulness levels measured by validated objective measures and parent’s reported instruments. Parents’ parental stress, parenting styles, ADHD related symptoms, well-being, rumination level and mindfulness levels will also be measured. Analysis is by intention to treat. The effects of intervention will be evaluated by comparing outcomes between the two arms, as well as comparing outcomes within subject through comparing measurements at baseline (T0), immediately after the 8 week intervention (T1) and at 3 (T2) and 6 (T3) months postintervention.Ethics and disseminationEthics approval has been granted by the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC). Participants will be required to sign informed consent form from both parents and children. Findings will be reported in conferences and peer-reviewed publications in accordance with recommendations of Consolidated Standards of Reporting Trials.Trial registration numberChiCTR1800014741; Pre-results.

scholarly journals COmmunity-based Rehabilitation after Knee Arthroplasty (CORKA): study protocol for a randomised controlled trial

Trials ◽  
2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Karen L. Barker ◽  
David Beard ◽  
Andrew Price ◽  
Francine Toye ◽  
Martin Underwood ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Knee Arthroplasty ◽  
Controlled Trial ◽  
Community Based ◽  
Community Based Rehabilitation ◽  
Randomised Controlled
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