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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00931294
First Posted: July 2, 2009
Last Update Posted: July 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Swedish Research Council
Stockholm County Council, Sweden
Information provided by:
Stockholm University
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Significant increase in saliva testosterone concentration during study period in choir group. [ Time Frame: 1 year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: June 30, 2009
First Posted: July 2, 2009
Last Update Posted: July 2, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents