Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 8:45 AM
Study NCT ID:
NCT01156935
Status:
UNKNOWN
Last Update Posted:
2010-07-12
First Post:
2010-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Laugh-yoga Intervention on Mood and Quality of Life Among Oncologic Patients in a Oncologic Clinic Setting.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-09', 'studyFirstSubmitDate': '2010-07-01', 'studyFirstSubmitQcDate': '2010-07-02', 'lastUpdatePostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life Questionnaire - QLQ-C30 & Positive-Negative Affect', 'timeFrame': 'Participants will fill QLQ-C30 & Positive -Negative Affect will be assessed before intervention and after three laugh - yoga sessions (that is after three weeks)'}], 'secondaryOutcomes': [{'measure': 'Blood analysis for WBC, CRP, T&B Lymphocytes', 'timeFrame': 'Before intervention and after three laugh-yoga interventions, that is after three weeks.'}]}, 'conditionsModule': {'keywords': ['Neoplasm', 'Laugh-Yoga', 'Mood', 'Quality of life'], 'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'Previous studies report low levels of mood and of quality of life among cancer patients. Laugh has been proved to improve mood and immune system function. The investigators propose to assess in a prospective randomised case-control study the affects of laugh-yoga intervention on mood levels and quality of life among cancer patients in a cancer clinic. The main hypothesis is that patients in laugh-yoga group will report higher mood and quality o life levels after intervention in comparison with no-intervention group. The second hypothesis is that immune system is the mediator of the effects of laugh-yoga intervention on mood and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* oncologic patients treated in oncologic clinic in Wolfson MC,\n* must be able to participate in Laugh Yoga session\n\nExclusion Criteria:\n\n* psychiatric or cognitive impairment,\n* deterioration in physical status,\n* treatment discontinuation'}, 'identificationModule': {'nctId': 'NCT01156935', 'briefTitle': 'Effects of Laugh-yoga Intervention on Mood and Quality of Life Among Oncologic Patients in a Oncologic Clinic Setting.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'Effects of Laugh-yoga Intervention on Mood and Quality of Life Among Oncologic Patients', 'orgStudyIdInfo': {'id': '0073-10-WOMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laugh yoga', 'description': 'experimental laugh yoga', 'interventionNames': ['Other: Laugh Yoga']}], 'interventions': [{'name': 'Laugh Yoga', 'type': 'OTHER', 'description': '1 hour including laugh, respiratory exercises and guided imagination by a group instructor specialized in laugh yoga', 'armGroupLabels': ['Laugh yoga']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Yossef Brener', 'oldOrganization': 'Wolfson MC'}}}}