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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Choir singing
Information Group
Sponsored by
Stockholm University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

More reduction in bowel pain according to standardised international IBS questionnaire in choir group than in study group after one year.

Secondary Outcome Measures

Significant increase in saliva testosterone concentration during study period in choir group.

Full Information

First Posted
June 30, 2009
Last Updated
July 1, 2009
Sponsor
Stockholm University
Collaborators
The Swedish Research Council, Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT00931294
Brief Title
Saliva Testosterone Increases in Irritable Bowel Syndrome (IBS) Patients Beginning Choir Singing
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stockholm University
Collaborators
The Swedish Research Council, Region Stockholm

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Choir singing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Information Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
More reduction in bowel pain according to standardised international IBS questionnaire in choir group than in study group after one year.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Significant increase in saliva testosterone concentration during study period in choir group.
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Töres Theorell, MD, PhD, Professor
Organizational Affiliation
Stress Research Institute at Stockholm University
Official's Role
Principal Investigator
Facility Information:
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
18951728
Citation
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.
Results Reference
result
Links:
URL
http://www.stressforskning.su.se
Description
Stress Research Institute homepage

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

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