Saliva Testosterone Increases in Irritable Bowel Syndrome (IBS) Patients Beginning Choir Singing
1 other identifier
interventional
55
1 country
1
Brief Summary
The hypothesis was that a one-year experience of choir singing once a week is more beneficial than group discussions to saliva concentration of testosterone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 30, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedJuly 2, 2009
July 1, 2009
1 year
June 30, 2009
July 1, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
More reduction in bowel pain according to standardised international IBS questionnaire in choir group than in study group after one year.
1 year
Secondary Outcomes (1)
Significant increase in saliva testosterone concentration during study period in choir group.
1 year
Interventions
Choir group participated in various relaxation, breathing and vocal exercises with the choir leader, and received the material "To Live with IBS" for home studies, weekly for 1 year. Saliva testosterone assessed 6 times per occasion; baseline, after 6, 9 and 12 months.
Meet in groups, studying and discussing on the same materials under the direction of a group leader, weekly, for 1 year. Saliva testosterone assessed 6 times per occasion; baseline, after 6, 9 and 12 months.
Eligibility Criteria
You may qualify if:
- IBS according to physician certificates.
- Wish to start choir singing but no such experience during past ten years.
- Acceptance of randomisation condition.
You may not qualify if:
- No serious somatic diseases.
- No abuse of alcohol or drugs.
- No ongoing acute psychiatric condition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stockholm Universitylead
- The Swedish Research Councilcollaborator
- Region Stockholmcollaborator
Study Sites (1)
Unknown Facility
Stockholm, Sweden
Related Publications (1)
Christina Grape RN, Theorell T, Wikstrom BM, Ekman R. Choir singing and fibrinogen. VEGF, cholecystokinin and motilin in IBS patients. Med Hypotheses. 2009 Feb;72(2):223-5. doi: 10.1016/j.mehy.2008.09.019. Epub 2008 Oct 31. No abstract available.
PMID: 18951728RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Töres Theorell, MD, PhD, Professor
Stress Research Institute at Stockholm University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 30, 2009
First Posted
July 2, 2009
Study Start
May 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
July 2, 2009
Record last verified: 2009-07