Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT00931294
Status:
COMPLETED
Last Update Posted:
2009-07-02
First Post:
2009-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Saliva Testosterone Increases in Irritable Bowel Syndrome (IBS) Patients Beginning Choir Singing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-01', 'studyFirstSubmitDate': '2009-06-30', 'studyFirstSubmitQcDate': '2009-07-01', 'lastUpdatePostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'More reduction in bowel pain according to standardised international IBS questionnaire in choir group than in study group after one year.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Significant increase in saliva testosterone concentration during study period in choir group.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '18951728', 'type': 'RESULT', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.stressforskning.su.se', 'label': 'Stress Research Institute homepage'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IBS according to physician certificates.\n* Wish to start choir singing but no such experience during past ten years.\n* Acceptance of randomisation condition.\n\nExclusion Criteria:\n\n* No serious somatic diseases.\n* No abuse of alcohol or drugs.\n* No ongoing acute psychiatric condition.'}, 'identificationModule': {'nctId': 'NCT00931294', 'briefTitle': 'Saliva Testosterone Increases in Irritable Bowel Syndrome (IBS) Patients Beginning Choir Singing', 'organization': {'class': 'OTHER', 'fullName': 'Stockholm University'}, 'officialTitle': 'Saliva Testosterone Increases in Choir Singer Beginners: a Randomised Controlled Trial to Test the Efficacy of Choir Singing in Irritable Bowel Syndrome (IBS) Patients', 'orgStudyIdInfo': {'id': 'SI 5.1 2007-17'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Choir singing', 'type': 'BEHAVIORAL', '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.'}, {'name': 'Information Group', 'type': 'BEHAVIORAL', '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.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Töres Theorell, MD, PhD, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stress Research Institute at Stockholm University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stockholm University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Swedish Research Council', 'class': 'OTHER_GOV'}, {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Stress Research Institute'}}}}