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

This study has been completed.
Sponsor:
Collaborators:
The Swedish Research Council
Stockholm County Council, Sweden
Information provided by:
Stockholm University
ClinicalTrials.gov Identifier:
NCT00931294
First received: June 30, 2009
Last updated: July 1, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention
Irritable Bowel Syndrome
Behavioral: Choir singing
Behavioral: Information Group

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

Resource links provided by NLM:


Further study details as provided by Stockholm University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Significant increase in saliva testosterone concentration during study period in choir group. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Behavioral: 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.
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931294

Locations
Sweden
Stockholm, Sweden
Sponsors and Collaborators
Stockholm University
The Swedish Research Council
Stockholm County Council, Sweden
Investigators
Principal Investigator: Töres Theorell, MD, PhD, Professor Stress Research Institute at Stockholm University
  More Information

Additional Information:
Publications:
Responsible Party: Stress Research Institute
ClinicalTrials.gov Identifier: NCT00931294     History of Changes
Other Study ID Numbers: SI 5.1 2007-17
Study First Received: June 30, 2009
Last Updated: July 1, 2009
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on April 16, 2014