Saliva Testosterone Increases in Irritable Bowel Syndrome (IBS) Patients Beginning Choir Singing

Irritable Bowel Syndrome Clinical Trial

Official title:

Saliva Testosterone Increases in Choir Singer Beginners: a Randomised Controlled Trial to Test the Efficacy of Choir Singing in Irritable Bowel Syndrome (IBS) Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931294
• Other study ID #: SI 5.1 2007-17
• Status: Completed
• Phase: N/A
• First received: June 30, 2009
• Last updated: July 1, 2009
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: July 2009
• Source: Stockholm University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The project aimed to study the health effects of regular choir singing for persons who are in a psychosomatic condition (Irritable Bowel syndrome - IBS). A group of IBS patients were randomized to choir singing or an information group were followed during one year with biological and psychosocial assessments. The 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. At the same time a comparison group with IBS patients meet in groups, studying and discussing on the same materials under the direction of a group leader. Both groups meet once per week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• IBS according to physician certificates.

• Wish to start choir singing but no such experience during past ten years.

• Acceptance of randomisation condition.

Exclusion Criteria:

• No serious somatic diseases.

• No abuse of alcohol or drugs.

• No ongoing acute psychiatric condition.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• Choir singing
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.
• Information Group
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Stockholm University	Stockholm County Council, Sweden, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Christina Grape RN, Theorell T, Wikström 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	More reduction in bowel pain according to standardised international IBS questionnaire in choir group than in study group after one year.		1 year	No
Secondary	Significant increase in saliva testosterone concentration during study period in choir group.		1 year	No

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