Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-03-11 @ 7:36 AM
Study NCT ID:
NCT03147235
Status:
COMPLETED
Last Update Posted:
2018-05-01
First Post:
2017-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of a Music Therapist Designed Listening Program on Intraoperative Vitrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014821', 'term': 'Vitrectomy'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2017-05-08', 'studyFirstSubmitQcDate': '2017-05-08', 'lastUpdatePostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-operative pain', 'timeFrame': 'during post-operative recovery time, approximately 2 hours', 'description': 'post-operative pain as measured by the Wong-Baker Faces pain scale, 0 is no pain, 10 is the worst pain'}], 'secondaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': 'during postoperative recovery time, approximately 2 hours', 'description': 'patient satisfaction as measured by a modified version of the The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey'}, {'measure': 'anti-anxiety medication', 'timeFrame': 'start to finish of surgery, approximately 1.5 hours', 'description': 'amount of anti-anxiety medication administered during surgery'}, {'measure': 'pain médication', 'timeFrame': 'start to finish of surgery, approximately 1.5 hours', 'description': 'amount of pain medication administered during surgery'}, {'measure': 'blood pressure', 'timeFrame': 'start to finish of surgery, approximately 1.5 hours', 'description': 'blood pressure during the surgical procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Music Therapy']}, 'descriptionModule': {'briefSummary': 'This will be a prospective, randomized controlled trial with patients randomly assigned to either the experimental or control group. The experimental group will be exposed to the independent variable (IV) and the control group will not be exposed to the IV. The IV will be a music therapist- designed listening program during surgery. A total of 60 patients will be consecutively enrolled and undergo block randomization to either a music listening group or a control group (no music). Trained medical research personnel will assist with various parts of the study and will be defined as those individuals who have completed and are up-to-date on the Collaborative Institutional Training Initiative (CITI) training. These individuals will consist of a board certified music therapist, practicing ophthalmologists, and physicians-in-training.', 'detailedDescription': 'This prospective trial will block randomize a consecutive cohort of patients undergoing routine vitrectomy surgery at an university hospital to a designed listening program during surgery or to nothing in order to determine whether music listening during surgery can measurably result in decreased patient pain assessed by the Wong-Baker Faces Pain scale. Secondary outcome measures will be blood pressure, need for anxiety medication, postoperative pain medication, and patient overall experience.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria will consist of patients already scheduled for elective vitrectomy surgery at a tertiary academic university hospital.\n\nExclusion Criteria:\n\n* Exclusion criteria consist of: patients with deafness or unilateral or bilateral severe hearing loss, unwillingness or inability to complete post-surgical surveys, previous vitrectomy surgeries, diagnosed anxiety disorder (claustrophobia, etc.), and/or chronic narcotic or substance abuse.'}, 'identificationModule': {'nctId': 'NCT03147235', 'briefTitle': 'The Effects of a Music Therapist Designed Listening Program on Intraoperative Vitrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'The Effects of a Music Therapist Designed Listening Program on Intraoperative Vitrectomy', 'orgStudyIdInfo': {'id': '#170400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vitrectomy with music listening', 'description': 'Patients undergoing vitrectomy surgery will listen to a designed playlist of music during the entire duration of surgery', 'interventionNames': ['Behavioral: vitrectomy with music listening']}, {'type': 'NO_INTERVENTION', 'label': 'vitrectomy without music listening', 'description': 'Patients undergoing vitrectomy surgery will not be exposed to music listening.'}], 'interventions': [{'name': 'vitrectomy with music listening', 'type': 'BEHAVIORAL', 'description': 'Those randomized to music listening will be exposed to a standardized playlist of previously validated relaxation music.', 'armGroupLabels': ['vitrectomy with music listening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Stephen J Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Stephen J. Kim, MD', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}