Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-02-21 @ 2:55 PM
Study NCT ID:
NCT02948595
Status:
COMPLETED
Last Update Posted:
2019-09-19
First Post:
2016-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video Feedback Versus Verbal Feedback
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': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-16', 'studyFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2016-10-26', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in ob/gyn resident physician self-efficacy as measured by self-efficacy questionnaire in video versus verbal feedback for simulated laparoscopic vaginal cuff closure', 'timeFrame': 'up to 18 months', 'description': 'Resident physicians will report their self-efficacy in completion of simulated laparoscopic vaginal cuff closure using an adaptation of a previously validated self-efficacy questionnaire. Their self-efficacy will be compared after completion of the task incorporating verbal feedback from a proctor to completion of the task incorporating review of video feedback provided by proctor.'}], 'secondaryOutcomes': [{'measure': 'Improvement in time of simulated laparoscopic vaginal cuff closure with video versus verbal feedback', 'timeFrame': 'up to 18 months', 'description': 'Resident physicians will be timed (in minutes) for completion of simulated laparoscopic vaginal cuff closure. Time will be compared in completion of the task after verbal feedback from a proctor versus completion of task after video feedback from a proctor.'}, {'measure': 'Improvement in skill of simulated laparoscopic vaginal cuff closure as measured by Objective Structured Assessment of Technical Skills (OSATS) global rating scale with video versus verbal feedback', 'timeFrame': 'up to 18 months', 'description': 'Two advanced gynecologic laparoscopists will review the films of the tasks for each resident physician. They will rate level of skill for each participant based on Objective Structured Assessment of Technical Skills (OSATS) global rating scale. The reviews will generate two scores for each participant: the score for the task completed after the resident receives verbal feedback and the score for the task completed after the resident receives video feedback. The two scores will then be compared for each participant.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Resident Surgical Training']}, 'descriptionModule': {'briefSummary': 'The long term goal of our research is to develop a curriculum for Obstetrics and Gynecology resident physicians that regularly employs use of video assessment to improve surgical skills. Regular use of video feedback may enable improved self-assessment and allow for formal documentation of proficiency. The overall objective is to compare the use of video feedback to use of structured verbal feedback in the simulated task of laparoscopic vaginal cuff closure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident Physician in the Department of Obstetrics and Gynecology\n\nExclusion Criteria:\n\n* Not a resident physician in the Department of Obstetrics and Gynecology'}, 'identificationModule': {'nctId': 'NCT02948595', 'briefTitle': 'Video Feedback Versus Verbal Feedback', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Video Feedback Versus Verbal Feedback in Simulated Laparoscopic Vaginal Cuff Closure', 'orgStudyIdInfo': {'id': '16-096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video feedback then verbal feedback', 'description': 'Video feedback followed by structured verbal feedback', 'interventionNames': ['Other: Video feedback followed by structured verbal feedback']}, {'type': 'EXPERIMENTAL', 'label': 'Verbal feedback then video feedback', 'description': 'Structured verbal feedback followed by video feedback', 'interventionNames': ['Other: Structured verbal feedback followed by video feedback']}], 'interventions': [{'name': 'Video feedback followed by structured verbal feedback', 'type': 'OTHER', 'description': 'Video feedback followed by structured verbal feedback', 'armGroupLabels': ['Video feedback then verbal feedback']}, {'name': 'Structured verbal feedback followed by video feedback', 'type': 'OTHER', 'description': 'Structured verbal feedback followed by video feedback', 'armGroupLabels': ['Verbal feedback then video feedback']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Obstetrics and Gynecology', 'investigatorFullName': 'Naomi Y Swanson', 'investigatorAffiliation': 'University of New Mexico'}}}}