Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-30 @ 3:53 AM
Study NCT ID:
NCT01184950
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2010-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Laparoscopy Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'OTHER'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'lastUpdateSubmitDate': '2022-11-07', 'studyFirstSubmitDate': '2010-08-11', 'studyFirstSubmitQcDate': '2010-08-18', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'observed structured assessment of technical skills (OSATS) Score', 'timeFrame': '0 Months', 'description': 'The residents are timed in seconds on various laparoscopy tasks. They are also rated by an objective blinded observer in several performance categories and given a score by the observer. These times and scores are recorded upon entry into the study, after randomization to intervention or no intervention.'}], 'secondaryOutcomes': [{'measure': 'observed structured assessment of technical skills (OSATS) score', 'timeFrame': '4 Months', 'description': 'The residents are timed in seconds on various laparoscopy tasks. They are also rated by an objective blinded observer in several performance categories and given a score by the observer. These times and scores are recorded 4 months after entry into the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Differences in OSATS Scores']}, 'descriptionModule': {'briefSummary': 'The use of virtual reality simulation training in obstetrics and gynecology has not been widely studied. The investigators hypothesized that residents randomized to the trainer would not perform differently when compared with those who are not randomized. Residents in Obstetrics and gynecology are randomized to a 4 month training course on our simulator. They are objectively evaluated performing various laparoscopy tasks prior to and after the course.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident in OB/Gyn at TriHealth\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01184950', 'briefTitle': 'Virtual Reality Laparoscopy Training', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'Prospective Randomized Trial of Virtual Reality Simulator Training in an Obstetrics and Gynecology Residency', 'orgStudyIdInfo': {'id': '10019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trainer Curriculum', 'interventionNames': ['Other: Trainer Curriculum']}, {'type': 'NO_INTERVENTION', 'label': 'No Curriculum'}], 'interventions': [{'name': 'Trainer Curriculum', 'type': 'OTHER', 'armGroupLabels': ['Trainer Curriculum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Devin Namaky, MD', 'oldOrganization': 'TriHealth Department of Obstetrics and Gynecology'}}}}