Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-01-20 @ 3:30 PM
Study NCT ID:
NCT00569933
Status:
COMPLETED
Last Update Posted:
2015-05-22
First Post:
2007-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Audio Recording for Improved Surgical Outcome (ARISO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000087983', 'term': 'Sound Recordings'}], 'ancestors': [{'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2007-12-06', 'studyFirstSubmitQcDate': '2007-12-07', 'lastUpdatePostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post Op pain', 'timeFrame': 'Day 1 to 3'}], 'secondaryOutcomes': [{'measure': 'Blood Loss, Nausea, sleep', 'timeFrame': 'Day 1 to Day 3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hip Surgery', 'Perioperative', 'suggestions/imagery'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Use of audio recordings (with suggestions and imagery for a better surgical outcome) studied in orthopedic patients.', 'detailedDescription': 'Pt undergoing orthopedic surgery are randomized into 3 groups. These interventionals will be listening to CD recording just prior to and during orthopedic surgery. The 2nd group will be listening to a recording before and during surgery without any positive suggestions. The 3rd group will be receiving usual care. Prior to hospital discharge patients will fill out a questionaire assessing their perception of their surgery and hospital stay. Pt. charts will be reviewed for use of pain, sleep, anesthesia and nausea medication and for the number of units of blood transfused. Pt. outcomes will be asssessed with this data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for total hip replacement under reginal anethesia at Mayo Clinic in Jacksonville, Fl.\n* Willingness to sign consent.\n* Age 18 or greater.'}, 'identificationModule': {'nctId': 'NCT00569933', 'briefTitle': 'Audio Recording for Improved Surgical Outcome (ARISO)', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Audio Recording for Improved Surgical Outcome', 'orgStudyIdInfo': {'id': '06-002226'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A/B/C', 'description': 'Patients are randomized to voice/music/ or no CD', 'interventionNames': ['Behavioral: Audio recording']}], 'interventions': [{'name': 'Audio recording', 'type': 'BEHAVIORAL', 'description': 'Using audio recording to investigate if possitive affirmations help with pain management and other post of compllication.', 'armGroupLabels': ['A/B/C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'James H. Stewart, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'James H. Stewart, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}