Functional Abdominal PainJust in TIMENCT02920268
Just in TIME - Intervention With Dance and Yoga for Girls With Recurrent Abdominal Pain
A study testing Dance and yoga intervention in people with Functional Abdominal Pain and IBS, run by Anna Duberg at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 13 years, women only
- Conditions the study is for
- Functional Abdominal Pain, IBS
- What is being tested?
- Dance and yoga intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2016to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University health care research center, Region Örebro county
Örebro, 70116
About this study
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.
Read more
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.
- Conditions
- Functional Abdominal Pain, IBS
- Being tested
- Dance and yoga intervention
- Keywords
- dance-intervention, yoga, adolescents, recurrent abdominal pain
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance and yoga interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention with dance and yoga sessions, two times a week in 8 months. Receives: Other: Dance and yoga intervention |
| Controls | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately after the intervention compared to the control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Functional Abdominal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Duberg
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden, Region Västmanland
- Responsible party
- Sponsor-investigator, Anna Duberg, Region Örebro County
- Investigators
- Anna Duberg, PhD, Principal investigator, University health care research center, Region Örebro county
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920268
- Sponsor's protocol ID
- 209695
- Acronym
- Just in TIME
- Status last verified
- Apr 2025
- First submitted
- 29 Sep 2016
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Folkesson M, Sarnblad S, Bringman L, Duberg A, Philipson A. Physical Activity in Young Girls With Functional Abdominal Pain Disorders: Findings of a Randomized Controlled Intervention Trial With Dance and Yoga. Clin J Pain. 2026 Jul 24. doi: 10.1097/AJP.0000000000001407. Online ahead of print.
PubMed 42494249Duberg 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.
PubMed 41273450Hogstrom 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.
PubMed 37152307Philipson 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.
PubMed 36646863Hogstrom 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.
PubMed 34529293Philipson 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.
PubMed 33320103
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Just in TIME - Intervention With Dance and Yoga for Girls With Recurrent Abdominal Pain
- ClinicalTrials.gov ID
- NCT02920268
- Acronym / sponsor ID
- Just in TIME / 209695
- Conditions
- Functional Abdominal Pain, IBS
- Keywords
- dance-intervention, yoga, adolescents, recurrent abdominal pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Anna DubergUniversity, hospital or other
- Collaborators
- Örebro University, Sweden, Region Västmanland
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Dance and yoga interventionIntervention with dance and yoga sessions, two times a week in 8 months. |
| Controls | No intervention | –No intervention |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance and yoga intervention | Other | Intervention |
Primary outcome
Faces pain scale (FPS-R)
Time frame: Immediately after the intervention compared to the control group
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Derived from this study: PubMed 42494249Folkesson M, Sarnblad S, Bringman L, Duberg A, Philipson A. Physical Activity in Young Girls With Functional Abdominal Pain Disorders: Findings of a Randomized Controlled Intervention Trial With Dance and Yoga. Clin J Pain. 2026 Jul 24. doi: 10.1097/AJP.0000000000001407. Online ahead of print.
- Derived from this study: PubMed 41273450Duberg 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.
- Derived from this study: PubMed 37152307Hogstrom 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.
- Derived from this study: PubMed 36646863Philipson 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.
- Derived from this study: PubMed 34529293Hogstrom 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.
- Derived from this study: PubMed 33320103Philipson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Duberg, PhD principal investigator
University health care research center, Region Örebro county
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance and yoga intervention in people with Functional Abdominal Pain and IBS, run by Anna Duberg at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faces pain scale (FPS-R) (time frame: Immediately after the intervention compared to the control group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02920268, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.