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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 May 2023
Main ID:  NCT02920268
Date of registration: 29/09/2016
Prospective Registration: No
Primary sponsor: Region Örebro County
Public title: Just in TIME - Intervention With Dance and Yoga for Girls With Recurrent Abdominal Pain Just in TIME
Scientific title: Just in TIME - Intervention With Dance and Yoga for Girls With Recurrent Abdominal Pain
Date of first enrolment: April 2016
Target sample size: 121
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT02920268
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Sweden
Contacts
Name:     Margareta Möller, Professor
Address: 
Telephone:
Email:
Affiliation:  University health care research center, Region Örebro county
Key inclusion & exclusion 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.



Age minimum: 9 Years
Age maximum: 13 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Functional Abdominal Pain
IBS
Intervention(s)
Other: Dance and yoga intervention
Primary Outcome(s)
Faces pain scale (FPS-R) [Time Frame: 24 months]
Secondary Outcome(s)
Secondary ID(s)
209695
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Örebro University, Sweden
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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