randomised control trial
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2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Pierre Schydlowsky ◽  
Marcin Szkudlarek ◽  
Ole Rintek Madsen

Abstract Background There is no consensus on the best training regimen for subacromial impingement syndrome (SIS). Several have been suggested, but never tested. The purpose of the study is to compare a comprehensive supervised training regimen (STR) based on latest evidence including heavy slow resistance training with a validated home-based regimen (HTR). We hypothesized that the STR would be superior to the HTR. Methods Randomised control trial with blinded assessor. 126 consecutive patients with SIS were recruited and equally randomised to 12 weeks of either supervised training regimen (STR), or home-based training regimen (HTR). Primary outcomes were Constant Score (CS) and Shoulder Rating Questionnaire (SRQ) from baseline and 6 months after completed training. Results were analyzed according to intention-to treat principles. The study was retrospectively registered in ClinicalTrials.gov. Date of registration: 07/06/2021. Identification number: NCT04915430. Results CS improved by 22.7 points for the STR group and by 23,7 points for the HTR (p = 0.0001). The SRQ improved by 17.7 and 18.1 points for the STR and the HTR groups respectively (p = 0.0001). The inter-group changes were non-significant. All secondary outcomes (passive and active range of motion, pain on impingement test, and resisted muscle tests) improved in both groups, without significant inter-group difference. Conclusion We found no significant difference between a comprehensive supervised training regimen including heavy training principles, and a home-based training program in patients with SIS.


2022 ◽  
Vol 9 (1) ◽  
pp. 40-41
Author(s):  
Sarah Moore ◽  
Denese Playford ◽  
Hanh Ngo ◽  
Rita Barbour ◽  
Kirsten Auret ◽  
...  

BACKGROUNDMedical students experience high levels of stress during their training. Literature suggests that mindfulness can reduce stress and increase self-compassion levels in medical students. However, most mindfulness training programs are delivered face-to-face and require significant time commitments, which can be challenging for rurally-based students with heavy academic workloads and limited support networks. PURPOSETo evaluate the feasibility and efficacy of a brief online Mindfulness training program for medical students based in rural areas, with regards to reducing stress, increasing self-compassion, mindfulness and study engagement. METHODSThis is a non-registered randomised control trial. Participants included both urban and rural medical students from UWA, University of Notre Dame and the RCSWA from 2018-2020. Participants were randomised to the intervention group, an 8-week online mindfulness training program, or the control group. Using quantitative-qualitative mixed-methods approach, we measured the frequency, duration and quality of the participants mindfulness meditation practice, and assessed changes in their perceived stress, self-compassion, mindfulness and study engagement levels. Further, the intervention group recorded a weekly reflective journal documenting their experience of the program. RESULTS114 participants were recruited to the study. 61 were randomised to the intervention, and 53 to the control. Quantitative analysis of the frequency, duration and quality of mindfulness meditation practice and changes in stress, self-compassion, mindfulness and study engagement is currently being conducted. Preliminary qualitative results reveal that participants experienced increased self-awareness, more mindfulness of their day-to-day activities, improved emotional regulation and increased productivity, while also facing difficulties with making time for their mindfulness practice. CONCLUSIONWe anticipate that this study will demonstrate that an online mindfulness training program tailored to reach rurally located medical students is feasible and effective in modifying their stress levels and psychological wellbeing. 


BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e047509
Author(s):  
Ingrid Larsson ◽  
Katarina Aili ◽  
Jens M Nygren ◽  
Pia Johansson ◽  
Håkan Jarbin ◽  
...  

Introduction and objectivesChildren with attention deficit hyperactivity disorder (ADHD) have an increased risk of sleep problems. Weighted blankets are one possible non-pharmacological intervention for these problems in this group of children. However, the effectiveness of weighted blankets is insufficiently investigated. This study aims to investigate the effectiveness of weighted blankets in terms of sleep, health-related outcomes and cost-effectiveness as well as to explore children’s and parents’ experiences of a sleep intervention with weighted blankets.Methods and analysisThis study is a randomised placebo-controlled crossover trial comparing the effect of weighted fibre blankets (active) with fibre blankets without weight (control). Children aged 6–13 years, recently diagnosed with uncomplicated ADHD with verified sleep problems, were included in the study. The study period is 4 weeks for each condition, respectively, and then an 8-week follow-up. A total of 100 children diagnosed with ADHD and sleep problems will enter the study. The primary outcomes are sleep and cost per quality-adjusted life years. The secondary outcomes are health-related quality of life, ADHD symptoms, psychological distress and anxiety. Interviews with a subsample of the participating children and parents will be conducted for exploring the experiences of the intervention.Ethics and disseminationEthical approval of the trial has been obtained from the Swedish Ethical Review Authority (number 2019–-2158) and conforms to the principles outlined in the Declaration of Helsinki (WMA, 2013). Results will be reported as presentations at peer-review conferences, in articles in peer-review journals and meetings with healthcare providers.Trial registration numberNCT04180189.


BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e047426
Author(s):  
Peter Gichangi ◽  
Lianne Gonsalves ◽  
Jefferson Mwaisaka ◽  
Mary Thiongo ◽  
Ndema Habib ◽  
...  

ObjectivesThe objective of this randomised controlled trial in Kenya was to assess the effect of delivering sexual and reproductive health (SRH) information via text message to young people on their ability to reject contraception-related myths and misconceptions.Design and settingA three-arm, unblinded randomised controlled trial with a ratio of 1:1:1 in Kwale County, Kenya.Participants and interventionsA total of 740 youth aged 18–24 years were randomised. Intervention arm participants could access informational SRH text messages on-demand. Contact arm participants received once weekly texts instructing them to study on an SRH topic on their own. Control arm participants received standard care. The intervention period was 7 weeks.Primary outcomeWe assessed change myths believed at baseline and endline using an index of 10 contraception-related myths. We assessed change across arms using difference of difference analysis.ResultsAcross arms, <5% of participants did not have any formal education, <10% were living alone, about 50% were single and >80% had never given birth. Between baseline and endline, there was a statistically significant drop in the average absolute number of myths and misconceptions believed by intervention arm (11.1%, 95% CI 17.1% to 5.2%), contact arm (14.4%, 95% CI 20.5% to 8.4%) and control arm (11.3%, 95% CI 17.4% to 5.2%) participants. However, we observed no statistically significant difference in the magnitude of change across arms.ConclusionsWe are unable to conclusively state that the text message intervention was better than text message ‘contact’ or no intervention at all. Digital health likely has potential for improving SRH-related outcomes when used as part of multifaceted interventions. Additional studies with physical and geographical separation of different arms is warranted.Trial registration numberISRCTN85156148.


2021 ◽  
Author(s):  
Sharon K Millard ◽  
Suzanne Murphy ◽  
Garry Barton ◽  
Maria Lethersich ◽  
Lorna Rixon ◽  
...  

Abstract Background: Having a stammer can have a significant effect on a child’s social, emotional and educational development. With approximately 66,000 children in the UK having a stammer, there is a need to establish an adequate evidence base to inform clinical practise. We describe a feasibility trial to explore the effectiveness of a new therapy programme for children aged 8-14: Palin Stammering Therapy for School Children (Palin STSC(8-14)). Preliminary data from the Michael Palin Centre, where the programme was developed, indicate that Palin STSC(8-14) is effective in reducing stammering frequency and impact for children, with beneficial effects for parents too. We will investigate the feasibility of the methods required for a definitive randomised control trial to investigate the application of this therapy by NHS speech and language therapists (SLTs), compared with ‘treatment as usual’ (TAU), beyond the specialist context in which it was developed.Methods: This is a two-arm feasibility cluster-randomised controlled trial of Palin STSC(8-14) with TAU control arm, and randomisation at the level of the SLT. Quantitative and qualitative data will be collected to examine: the recruitment and retention of therapists and families; the acceptability of the research processes and the therapeutic intervention; the appropriateness of the therapy outcome measures. Assessments will be completed by children and parents at baseline and six months later, including measures of: stammering severity; the impact of child’s stammering on both children and parents; child temperament, behaviour, peer relations, anxiety; quality of life; and, economic outcomes. There will also be a qualitative process evaluation, including interviews with parents, children, SLTs and SLT managers to explore the acceptability of both the research and therapy methods. Treatment fidelity will be examined through analysis of therapy session records and recordings. Discussion: The findings of this feasibility trial will inform the decision as to whether to progress to a full-scale randomised controlled trial to explore the effectiveness of Palin STSC(8-14) when compared to Treatment as Usual in NHS SLT services. There is a strong need for an evidence based intervention for school age children who stammer. Trial registration: ISRCTN. ISRCTN17058884. Registered 18th December 2019. https://www.isrctn.com/ISRCTN17058884


Cancers ◽  
2021 ◽  
Vol 13 (24) ◽  
pp. 6284
Author(s):  
Marcus J. Brookes ◽  
Corey D. Chan ◽  
Fabio Nicoli ◽  
Timothy P. Crowley ◽  
Kanishka M. Ghosh ◽  
...  

Background: Sarcomas are rare, aggressive cancers which can occur in any region of the body. Surgery is usually the cornerstone of curative treatment, with negative surgical margins associated with decreased local recurrence and improved overall survival. Indocyanine green (ICG) is a fluorescent dye which accumulates in sarcoma tissue and can be imaged intraoperatively using handheld near-infrared (NIR) cameras, theoretically helping guide the surgeon’s resection margins. Methods: Patients operated on between 20 February 2019 and 20 October 2021 for intermediate to high grade sarcomas at our centres received either conventional surgery, or were administered ICG pre-operatively followed by intra-operative NIR fluorescence guidance during the procedure. Differences between the unexpected positive margin rates were compared. Results: 115 suitable patients were identified, of which 39 received ICG + NIR fluorescence guided surgery, and 76 received conventional surgery. Of the patients given ICG, 37/39 tumours fluoresced, and surgeons felt the procedure was guided by the intra-operative images in 11 cases. Patients receiving ICG had a lower unexpected positive margin rate (5.1% vs. 25.0%, p = 0.01). Conclusions: The use of NIR fluorescence cameras in combination with ICG may reduce the unexpected positive margin rate for high grade sarcomas. A prospective, multi-centre randomised control trial is now needed to validate these results.


2021 ◽  
Author(s):  
◽  
Amanda Wallis

<p>New Zealand is exposed to many natural hazards and yet, despite its heightened risk, national rates of individual preparedness remain low. Previous research has shown that place attachment is positively associated with disaster preparedness. My work builds on this research and explores (i) the relationship between place attachment and preparedness intentions and behaviours and (ii) the potential for a place attachment intervention to change preparedness and behaviours.  In the first two studies (Chapter 2), I examined 1) participants’ levels of place attachment at different spatial scales, 2) participants’ preparedness (intentions and behaviours), and 3) place attachment as a mediator of previously identified demographic predictors of preparedness. Findings show that place attachment is associated with both preparedness intentions and behaviour when measured simultaneously. When controlling for socio-demographic predictors, participants who reported stronger house and neighbourhood attachment also reported stronger intentions to prepare (Study 1). In Study 2, house attachment was associated with mitigation preparedness behaviour, whereas neighbourhood attachment was associated with community preparedness behaviour. House and neighbourhood attachment mediated the relationship between homeownership, length of residence, and preparedness. These findings suggest that place attachment varies by spatial scale which matters for different types of disaster preparedness.  The second set of studies (Chapter 3) consisted of a pilot study with undergraduate students (Study 3) and a two-wave randomised control trial with a community sample (Study 4) to examine whether the use of a place visualisation intervention would strengthen people’s intentions to prepare (at Time 1) and encourage people to implement preparedness behaviours (at Time 2, two weeks later). I developed and implemented a guided place-based visualisation task, which asked participants to visualise a place they feel attached to (their house or in their neighbourhoods) and compared the effectiveness with visualisation of a neutral place. I expected that visualising one’s house or neighbourhood (i.e. a place people feel attached to) would result in stronger intentions to prepare and higher uptake of preparedness behaviours at a two-week follow-up when compared to people who visualised a neutral place. I did not find any meaningful effect of place visualisation on preparedness intentions or behaviours.  In Study 5 (Chapter 4), I used qualitative methods to gain a deeper understanding of the quantitative findings. I thematically analysed qualitative data gathered as part of a previous survey (Study 1) to understand people’s relationships to places in more depth and to identify what people think is important about their attachment to places at different spatial scales. I identified six key themes (i.e. social, physical, residential, functional, sentimental, psychological) that were important for place attachment across four different spatial scales.  Finally, across two chapters, I further explored my place visualisation intervention and why it may not have been as effective as expected. To this end, I first provided a mixed- methods analysis of how participants engaged with the intervention task (e.g. time spent on the task and number of words written) (Study 6, Chapter 5). Then, I used insights from behaviour change theories (Chapter 6) to discuss the findings from Studies 1-6 as they relate to the advancement of place attachment theory, application to disaster preparedness behaviour-change, and implications for intervention design and implementation. In the final chapter (Chapter 7), I discussed the key findings and implications across the entire thesis and how these can be used to inform theory, practice, and future research directions.</p>


2021 ◽  
Author(s):  
◽  
Amanda Wallis

<p>New Zealand is exposed to many natural hazards and yet, despite its heightened risk, national rates of individual preparedness remain low. Previous research has shown that place attachment is positively associated with disaster preparedness. My work builds on this research and explores (i) the relationship between place attachment and preparedness intentions and behaviours and (ii) the potential for a place attachment intervention to change preparedness and behaviours.  In the first two studies (Chapter 2), I examined 1) participants’ levels of place attachment at different spatial scales, 2) participants’ preparedness (intentions and behaviours), and 3) place attachment as a mediator of previously identified demographic predictors of preparedness. Findings show that place attachment is associated with both preparedness intentions and behaviour when measured simultaneously. When controlling for socio-demographic predictors, participants who reported stronger house and neighbourhood attachment also reported stronger intentions to prepare (Study 1). In Study 2, house attachment was associated with mitigation preparedness behaviour, whereas neighbourhood attachment was associated with community preparedness behaviour. House and neighbourhood attachment mediated the relationship between homeownership, length of residence, and preparedness. These findings suggest that place attachment varies by spatial scale which matters for different types of disaster preparedness.  The second set of studies (Chapter 3) consisted of a pilot study with undergraduate students (Study 3) and a two-wave randomised control trial with a community sample (Study 4) to examine whether the use of a place visualisation intervention would strengthen people’s intentions to prepare (at Time 1) and encourage people to implement preparedness behaviours (at Time 2, two weeks later). I developed and implemented a guided place-based visualisation task, which asked participants to visualise a place they feel attached to (their house or in their neighbourhoods) and compared the effectiveness with visualisation of a neutral place. I expected that visualising one’s house or neighbourhood (i.e. a place people feel attached to) would result in stronger intentions to prepare and higher uptake of preparedness behaviours at a two-week follow-up when compared to people who visualised a neutral place. I did not find any meaningful effect of place visualisation on preparedness intentions or behaviours.  In Study 5 (Chapter 4), I used qualitative methods to gain a deeper understanding of the quantitative findings. I thematically analysed qualitative data gathered as part of a previous survey (Study 1) to understand people’s relationships to places in more depth and to identify what people think is important about their attachment to places at different spatial scales. I identified six key themes (i.e. social, physical, residential, functional, sentimental, psychological) that were important for place attachment across four different spatial scales.  Finally, across two chapters, I further explored my place visualisation intervention and why it may not have been as effective as expected. To this end, I first provided a mixed- methods analysis of how participants engaged with the intervention task (e.g. time spent on the task and number of words written) (Study 6, Chapter 5). Then, I used insights from behaviour change theories (Chapter 6) to discuss the findings from Studies 1-6 as they relate to the advancement of place attachment theory, application to disaster preparedness behaviour-change, and implications for intervention design and implementation. In the final chapter (Chapter 7), I discussed the key findings and implications across the entire thesis and how these can be used to inform theory, practice, and future research directions.</p>


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