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Completed

NCT Number: NCT00931294

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Choir singing

Behavioral

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

Behavioral

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 outcomes

  1. 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 outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Stockholm University

Other

Collaborators

  • Region Stockholm
  • The Swedish Research Council

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 2, 2009
Registry last updated
Jul 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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