Ignite Creation Date:
2025-12-17 @ 2:50 PM
Ignite Modification Date:
2025-12-23 @ 5:41 PM
Study NCT ID:
NCT00179595
Status:
COMPLETED
Last Update Posted:
2017-02-16
First Post:
2005-09-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Does the Relaxation Response Inhibit Acute Stress?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.'}], 'secondaryOutcomes': [{'measure': 'To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nitric oxide, volumetric oxygen consumption'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purposes of this study are:\n\n1. To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.\n2. To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.\n\nSince stress is a factor in the development of many health conditions, a further understanding of the mechanisms of the RR should be developed. The project is designed to determine how the RR can improve the quality of life that has been adversely affected by stress.', 'detailedDescription': 'The purposes of this study are:\n\n1. To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.\n2. To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.\n\nSince stress is a factor in the development of many health conditions, a further understanding of the mechanisms of the RR should be developed. The project is designed to determine how the RR can improve the quality of life that has been adversely affected by stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy individual\n* age:18-49 years\n* able to read and understand English\n* able to attend al study visits\n* access to a telephone (to schedule visits)\n\nExclusion Criteria:\n\n* current smoking\n* asthma\n* current use of any prescription or psychoactive medications or supplements\n* either:\n\n 1. no prior experience with RR eliciting techniques\n 2. at least 3 years of regular RR elicitation (at least 20 min/day)\n* BMI \\>30\n* exhaled nitric oxide levels \\>60 ppb\n* abnormal lab values (Hct \\<32,creatinine \\>1.3, glucose \\>200\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT00179595', 'briefTitle': 'Does the Relaxation Response Inhibit Acute Stress?', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Does the Relaxation Response Inhibit Acute Stress?', 'orgStudyIdInfo': {'id': '2001P001747'}, 'secondaryIdInfos': [{'id': 'H75-CCH-123424'}, {'id': 'H75-CCH-119124'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'relaxation response- meditation', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth-Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Herbert Benson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}