Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT01351402
Status:
COMPLETED
Last Update Posted:
2011-05-10
First Post:
2011-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Massage Versus Rest on Hormones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008405', 'term': 'Massage'}, {'id': 'C092779', 'term': 'RE1-silencing transcription factor'}], 'ancestors': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'BASIC_SCIENCE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-08', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-09', 'studyFirstSubmitDate': '2011-05-06', 'studyFirstSubmitQcDate': '2011-05-09', 'lastUpdatePostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxytocin', 'timeFrame': 'Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.', 'description': 'Participants receive a blood draw at baseline and immediately following 15 minutes of massage or rest and oxytocin will be measured from this sample.'}], 'secondaryOutcomes': [{'measure': 'Adrenocorticotrophic hormone (ACTH)', 'timeFrame': 'Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.', 'description': 'Participants will receive a blood draw at baseline and immediately following 15 minutes of massage or rest, and ACTH will be measured in these blood samples.'}, {'measure': 'Beta-endorphin', 'timeFrame': 'Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.', 'description': 'Participants will receive a blood draw at baseline and immediately following 15 minutes of massage or rest, and B-endorphin will be measured from these samples.'}, {'measure': 'Interleukin-1alpha (IL-1a)', 'timeFrame': 'Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.', 'description': 'Participants will receive a blood draw at baseline and immediately following 15 minutes of massage or rest, and IL-1a will be measured from these samples.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Massage', 'Rest'], 'conditions': ['Massage', 'Rest']}, 'descriptionModule': {'briefSummary': 'This study will investigate the effects of 15 minutes of massage compared to 15 minutes of quiet rest on physiological variables. Specifically, the investigators will measure the effects on levels of the social hormone oxytocin, and on other physiological variables that interact with oxytocin or that may be influenced by massage (including ACTH, Beta-endorphin, and IL-1alpha). The investigators will also investigate whether, in the case of hormones changes, these influence social decision making.', 'detailedDescription': 'Interested participants will have the experiment explained both verbally and in writing, and asked to give their informed consent in writing. After consent, the participants will be led to a private room for their first 30ml blood draw by a qualified phlebotomist. Participants will then have a second 30ml blood draw.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anyone English speaking and over the age of 18.\n\nExclusion Criteria:\n\n* Minors and anyone who has used illicit drugs or alcohol in the last 24 hours.'}, 'identificationModule': {'nctId': 'NCT01351402', 'briefTitle': 'Effects of Massage Versus Rest on Hormones', 'organization': {'class': 'OTHER', 'fullName': 'Claremont Graduate University'}, 'officialTitle': 'Investigating the Effects of Massage vs. Rest on Oxytocin, ACTH, and B-endorphins', 'orgStudyIdInfo': {'id': '00012002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Massage or Rest', 'type': 'PROCEDURE', 'description': 'Participants either received 15 minutes of moderate pressure Swedish massage on the upper back, or rested quietly sitting in a chair for 15 minutes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cassel, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Claremont Graduate University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gruter Institute', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Paul J. Zak, Ph.D.', 'oldOrganization': 'Center for Neuroeconomic Studies, Claremont Graduate University'}}}}