Just in TIME - Intervention With Dance and Yoga for Girls With Recurrent Abdominal Pain (Just in TIME)
Recurrent abdominal pain affects up to 37% of school-age children, mostly girls. These problems results in decreased quality-of-life, absence from school, lower sleep quality and increased health-care consumption. Long-term effects are lasting pain-symptoms and increased risk for psychiatric illness.
The scientific evidence for interventions towards long-term pain in children is limited and pharmacological treatment is not effective. Cognitive behavioral therapy has shown some effect but is time- and resource consuming. Dance and yoga can enhance positive protective factors through better body awareness and increased self-regulation. Relaxation in yoga also has positive effect on abdominal pain.
The aim of this study is to evaluate the effects of an intervention with dance and yoga for girls, 9 to 13 years old, with recurrent abdominal pain. The participants will be identified through pediatric clinics in Örebro County, primary health care and school health care. They will be randomized to intervention with weekly dance- and yoga class for 8 months or control group with standard treatment. Primary outcome is the fraction of girls in each group who, direct after intervention, has decreased their maximum pain measured by Faces Pain Scale. Secondary outcomes are stress, psychical health, well-being, school and sleep functions, physical activity and health-economy. The study group will be followed up for two years.
Just-in-TIME is an interdisciplinary research group with expertise in interventions for psychosomatic problems in children and adolescents. TIME, which stands for Try, Identify, Move and Enjoy, also characterizes this project, aiming at decreasing recurrent abdominal pain through an intervention with dance and yoga for 9-13 year old girls.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Örebro, Sweden, 70116
- University Health Care Research Center, Region Örebro County
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Girls 9-13 years old as of pediatricians receive or have received the diagnosis functional abdominal pain or IBS according to the ROME III criteria and stating that they have persist symptoms for at least 2 months after completed investigation from pediatricians. Persistent symptoms are measured by pain diary at baseline and means that the girl at least once in the pain diary estimates 4 or higher as measured by the Faces Pain Scale (FPS-R).
Exclusion Criteria:
- Simultaneous celiac disease or inflammatory bowel disease (IBD).
- Difficulties in following verbal instructions such as hearing impaired or mentally retarded.
- Girls who are deemed to have such serious psychological symptoms that other treatment is required. All participants in the study, which estimates over 13 at the Children's Depression Screener (Child-S), will meet a psychologist / psychiatrist to assess whether they can participate in the study or have direct access to the Children and Youth psychiatry.
- Children treated with CBT.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intervention
Intervention with dance and yoga sessions, two times a week in 8 months.
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No Intervention: Controls
No intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Faces pain scale (FPS-R)
Time Frame: Immediately after the intervention compared to the control group
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Has the perceived abdominal pain decreased by a 8 months long intervention with regular dance and yoga for girls with recurrent abdominal pain, measured immediately after the intervention compared to the control group?
The primary outcome is the proportion of girls in each group that have lowered their maximal abdominal pain measured by Faces Pain Scale (FPS-R).
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Immediately after the intervention compared to the control group
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Duberg, PhD, University Health Care Research Center, Region Örebro County
Publications and helpful links
General Publications
- Hogstrom S, Philipson A, Ekstav L, Eriksson M, Fagerberg UL, Falk E, Moller M, Sandberg E, Sarnblad S, Duberg A. Dance and yoga reduced functional abdominal pain in young girls: A randomized controlled trial. Eur J Pain. 2022 Feb;26(2):336-348. doi: 10.1002/ejp.1862. Epub 2021 Sep 21.
- Philipson A, Sarnblad S, Ekstav L, Eriksson M, Fagerberg UL, Moller M, Morelius E, Duberg A. An Intervention With Dance and Yoga for Girls With Functional Abdominal Pain Disorders (Just in TIME): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Dec 15;9(12):e19748. doi: 10.2196/19748.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 209695
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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