Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT02349204
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2015-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Music on Surgical Skill in the Setting of Simulated Intraocular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-20', 'studyFirstSubmitDate': '2015-01-05', 'studyFirstSubmitQcDate': '2015-01-23', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Task score', 'timeFrame': 'Assessed up to 12 weeks after randomization', 'description': 'The participants will perform tasks on a simulator on three separate days. The outcome will be measured at each of these visits.'}], 'secondaryOutcomes': [{'measure': 'Time to complete the task', 'timeFrame': 'Assessed up to 12 weeks after randomization', 'description': 'The participants will perform tasks on a simulator on three separate days. The outcome will be measured at each of these visits.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Simulator', 'Music', 'Mozart Effect'], 'conditions': ['Surgical Performance']}, 'descriptionModule': {'briefSummary': 'Music is commonly heard in operating room. The goal of this study is to measure the effect of music on surgical performance using a intraocular surgery simulator. The music chosen is Sonata for 2 pianos D-440 from Mozart. The participants will complete 2 tasks on the simulator, both with and without music, in a randomized sequence. The results will be subtracted from the simulator and analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ophthalmology residents at Laval University\n* Ophthalmologist at Centre Hospitalier Universitaire de Québec\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02349204', 'briefTitle': 'The Effect of Music on Surgical Skill in the Setting of Simulated Intraocular Surgery', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'The Effect of Music on Surgical Skill in the Setting of Simulated Intraocular Surgery', 'orgStudyIdInfo': {'id': '2015-1938'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exposure to music', 'description': "The participants in this groups will have to complete the tasks on the intraocular surgery simulator while listening to Mozart's sonata for 2 pianos in D-440", 'interventionNames': ["Behavioral: Music - Mozart's sonata for 2 pianos in D-440"]}, {'type': 'NO_INTERVENTION', 'label': 'No exposure', 'description': 'The participants in this groups will have to complete the tasks on the intraocular surgery simulator in silence'}], 'interventions': [{'name': "Music - Mozart's sonata for 2 pianos in D-440", 'type': 'BEHAVIORAL', 'armGroupLabels': ['Exposure to music']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1S 4L8', 'city': 'Québec', 'country': 'Canada', 'facility': "Centre Universitaire d'Ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Mathieu Caissie, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de recherche du CHU de Québec : Université Laval'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}