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Just in TIME - Intervention With Dance and Yoga for Girls With Recurrent Abdominal Pain (Just in TIME)

Primary Purpose

Functional Abdominal Pain, IBS

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Dance and yoga intervention
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Functional Abdominal Pain focused on measuring dance-intervention, yoga, adolescents, recurrent abdominal pain

Eligibility Criteria

9 Years - 13 Years (Child)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University health care research center, Region Örebro county

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Controls

Arm Description

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

No intervention

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
September 29, 2016
Last Updated
April 25, 2023
Sponsor
Region Örebro County
Collaborators
Örebro University, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02920268
Brief Title
Just in TIME - Intervention With Dance and Yoga for Girls With Recurrent Abdominal Pain
Acronym
Just in TIME
Official Title
Just in TIME - Intervention With Dance and Yoga for Girls With Recurrent Abdominal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2016 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Örebro County
Collaborators
Örebro University, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Abdominal Pain, IBS
Keywords
dance-intervention, yoga, adolescents, recurrent abdominal pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention with dance and yoga sessions, two times a week in 8 months.
Arm Title
Controls
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Dance and yoga intervention
Primary Outcome Measure Information:
Title
Faces pain scale (FPS-R)
Description
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).
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margareta Möller, Professor
Organizational Affiliation
University health care research center, Region Örebro county
Official's Role
Study Chair
Facility Information:
Facility Name
University health care research center, Region Örebro county
City
Örebro
ZIP/Postal Code
70116
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34529293
Citation
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.
Results Reference
derived
PubMed Identifier
33320103
Citation
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.
Results Reference
derived

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Just in TIME - Intervention With Dance and Yoga for Girls With Recurrent Abdominal Pain

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