NCT02920268

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

7.7 years

First QC Date

September 29, 2016

Last Update Submit

April 2, 2025

Conditions

Keywords

dance-interventionyogaadolescentsrecurrent abdominal pain

Outcome Measures

Primary Outcomes (1)

  • Faces pain scale (FPS-R)

    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).

    Immediately after the intervention compared to the control group

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention with dance and yoga sessions, two times a week in 8 months.

Other: Dance and yoga intervention

Controls

NO INTERVENTION

No intervention

Interventions

Eligibility Criteria

Age9 Years - 13 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University health care research center, Region Örebro county

Örebro, 70116, Sweden

Location

Related Publications (5)

  • Duberg A, Eriksson M, Philipson A. Parent-child agreement in reporting somatic distress, gastrointestinal symptoms, mental health, and general health in girls with functional abdominal pain. Eur J Pediatr. 2025 Nov 22;184(12):780. doi: 10.1007/s00431-025-06640-5.

  • Hogstrom S, Eriksson M, Morelius E, Duberg A. "A source of empowerment and well-being": Experiences of a dance and yoga intervention for young girls with functional abdominal pain disorders. Front Pediatr. 2023 Apr 21;11:1040713. doi: 10.3389/fped.2023.1040713. eCollection 2023.

  • Philipson A, Duberg A, Hagberg L, Hogstrom S, Lindholm L, Moller M, Ryen L. The Cost-Effectiveness of a Dance and Yoga Intervention for Girls with Functional Abdominal Pain Disorders. Pharmacoecon Open. 2023 Mar;7(2):321-335. doi: 10.1007/s41669-022-00384-w. Epub 2023 Jan 16.

  • 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.

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Anna Duberg, PhD

    University health care research center, Region Örebro county

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 29, 2016

First Posted

September 30, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations