Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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8 May 2023 |
Main ID: |
NCT02920268 |
Date of registration:
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29/09/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Just in TIME - Intervention With Dance and Yoga for Girls With Recurrent Abdominal Pain
Just in TIME |
Scientific title:
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Just in TIME - Intervention With Dance and Yoga for Girls With Recurrent Abdominal Pain |
Date of first enrolment:
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April 2016 |
Target sample size:
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121 |
Recruitment status: |
Active, not recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02920268 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Margareta Möller, Professor |
Address:
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Telephone:
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Email:
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Affiliation:
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University health care research center, Region Örebro county |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Functional Abdominal Pain
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IBS
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Intervention(s)
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Other: Dance and yoga intervention
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Primary Outcome(s)
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Faces pain scale (FPS-R)
[Time Frame: 24 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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