Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 8, 2020
Date Accepted: Nov 5, 2020
“Just in Time” – An Intervention with Dance and Yoga for Girls with Functional Abdominal Pain Disorders: Study Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Functional abdominal pain disorders (FAPDs) affect many children worldwide, predominantly girls, and cause considerable suffering and often long-term negative consequences for the individuals and the society. Evidence-based and cost-effective treatments are therefore strongly needed. Physical activity has shown promising effects in the practical management of FAPDs. Dance and yoga are both popular activities that has been shown to provide significant psychological and pain-related benefits with minimal risk. The activities complement each other in that dance involves dynamic, rhythmic physical activity, while yoga enhances relaxation and focus.
Objective:
This study aims to evaluate the effects of a dance and yoga intervention among 9- to 13-year-old girls with FAPDs.
Methods:
The study is a prospective randomized controlled trial among girls 9-13 years of age with functional abdominal pain and/or irritable bowel syndrome. The intervention consists of dance- and yoga sessions twice weekly for 8 months; controls receive standard care. Outcomes are measured at baseline and after 4, 8, 12 and 24 months, and long-term follow-up will be conducted 5 years from baseline. Questionnaires, interviews and biomarker measures, such as cortisol in saliva and fecal samples, are used. The primary outcome is the proportion of girls in each group with reduced pain, measured by the Faces Pain Scale -revised in a pain diary immediately after the intervention. Secondary outcomes include gastrointestinal symptoms, general health, mental health, stress and physical activity. The study also includes qualitative evaluations and health economic analyses. This study was approved by the Regional Ethical Review Board in Uppsala (Dnr 2016/082 1-2).
Results:
Data collection began in October 2016. The intervention has been performed during three periods from 2016 through 2019. The final 5-years follow-up is anticipated to be completed by fall 2023.
Conclusions:
Cost-effective and easily accessible interventions are warranted to reduce the negative consequences arising from FAPDs in young girls. Physical activity is an effective strategy but intervention studies are needed to better understand what type of activities that facilitate regular participation for this target group. The “Just in Time”-study will provide insights regarding the effectiveness of dance and yoga and is anticipated to contribute to the challenging work of reducing the burden of FAPDs for young girls. The results will be published in peer-reviewed journals and academic conferences and will compose parts of PhD theses. Clinical Trial: Clinical Trials (NCT02920268)
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