Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-05 @ 8:51 AM
Study NCT ID:
NCT02837133
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2016-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Single Session of Integrated Yoga Therapy Compared With Other Relaxation Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-07-14', 'studyFirstSubmitDate': '2016-07-07', 'studyFirstSubmitQcDate': '2016-07-14', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of scores on the Subjective Units of Distress (SUD) scale', 'timeFrame': '1) immediately after the subjects arrived at the facility (baseline) and 2) immediately after the intervention', 'description': 'SUD is a scale of 0 (comfort) to 10 (discomfort) for measuring the subjective intensity of disturbance or distress currently experienced by an individual covering both physical and mental aspects.'}]}, 'conditionsModule': {'conditions': ['Yoga']}, 'descriptionModule': {'briefSummary': 'Typically a course of yoga therapy for stress management takes place over a week, however, investigators are often asked to provide a single session for workers. The aim of this study is to assess the benefits of a single session of an integrated yoga program compared with other relaxation techniques for the staff of schools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* school staff members, including school managers, teachers, school nurses, school office workers, nutritionists and cooks\n* volunteers attending a stress management workshop\n\nExclusion Criteria:\n\n* those who had any previous experience of practicing yoga or any relaxation procedures'}, 'identificationModule': {'nctId': 'NCT02837133', 'briefTitle': 'Effects of a Single Session of Integrated Yoga Therapy Compared With Other Relaxation Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Hiroshima University'}, 'orgStudyIdInfo': {'id': 'HiroshimaU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'other techniques group', 'description': 'theory and practice of pair massage with tapping, stretching of the ankle and neck, and autogenic training', 'interventionNames': ['Behavioral: integrated yoga program']}], 'interventions': [{'name': 'integrated yoga program', 'type': 'BEHAVIORAL', 'description': 'the program as a one-time session for 3 hours as a component of a Stress Management Education program', 'armGroupLabels': ['other techniques group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hiroshima University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Institute of Biomedical & Health Sciences', 'investigatorFullName': 'Hitoshi Okamura', 'investigatorAffiliation': 'Hiroshima University'}}}}