Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT06164158
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2023-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Procedural Videos in Teaching the Surgery Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2023-12-07', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The GARS (global assessment rating score).', 'timeFrame': '3 Months', 'description': 'To determine the GARS score of participants before and after watching the procedural video and compare them which include the following\n\n* Respect for tissue\n* Time and motion\n* Instrument handling\n* Depth perception\n* Bimanual dexterity Total number will be calculated in 2 phases and will be out of 25 and the higher the score, the better the trainee is. The main aspect to be seen will be whether the trainee surgeon improved his GARS score following watching procedural video or not.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Educational Techniques', 'Surgical Procedure, Unspecified']}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial was conducted at Pakistan Institute of Medical Sciences (PIMS) Islamabad after approval from the Institutional ethics review board. Fifty-four surgical residents in training and who have completed at least 3 months of surgical training were enrolled in the study. After the residents had performed the procedure initially, 27 were made to watch the procedural videos and learn the steps of the procedure while those of the other group did not watch the videos. Participants of both the groups were made to perform the procedure. GARS (global assessment rating score) was calculated for each individual during their second procedure. All procedures were performed under the supervision of a consultant surgeon who was blinded about the groups and make assessment of the GARS (global assessment rating score).', 'detailedDescription': 'This study was conducted in 2 phases. In Phase-I just after the enrollment, all the residents performed the procedure from which initial GARS (global assessment rating score) assessment was made. Phase-I was followed by allocation into the groups i.e., study and control groups. In phase-2, a video of surgical procedure was obtained through internet. After all residents have done the procedure initially, 27 participants of the study group were made to watch the videos and learn the steps of procedure while those of the other group did not watch the videos. Participants of both the groups were made to perform the procedure again. GARS (global assessment rating score) was calculated for each individual in their second procedure which included following scores:\n\n1. Respect for tissue\n2. Time and motion\n3. Instrument Handling\n4. Depth perception\n5. Bimanual Dexterity All elements scored between 1-5 with a total of 25 score. All procedures were performed under the supervision of a consultant surgeon who was blinded about the groups and make assessment according to the GARS (global assessment rating score).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the postgraduate trainees in surgery and allied specialties\n* Age 25 to 35 years\n* Both Genders\n* Any year of training with at least 3 months of surgical training.\n\nExclusion Criteria:\n\n* Those residents who did not wish to participate\n* Those with less than 3 months of training.\n* Consultant surgeons'}, 'identificationModule': {'nctId': 'NCT06164158', 'briefTitle': 'Role of Procedural Videos in Teaching the Surgery Residents', 'organization': {'class': 'OTHER', 'fullName': 'Shaheed Zulfiqar Ali Bhutto Medical University'}, 'officialTitle': 'Role of Procedural Videos in Teaching the Surgery Residents: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'ShaheedZABMU123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Half were made to watch the procedural videos and learn the steps of the procedure and then made to perform procedure', 'interventionNames': ['Other: Procedural Videos']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group', 'description': 'Other half group did not watch the procedural videos and were made to perform procedure.', 'interventionNames': ['Other: No procedural videos']}], 'interventions': [{'name': 'Procedural Videos', 'type': 'OTHER', 'description': 'A randomized controlled trial was conducted at Pakistan Institute of Medical Sciences (PIMS) Islamabad between September 1, 2023 to November 30, 2023 under ethical approval from the Institutional ethical review board.', 'armGroupLabels': ['Study Group']}, {'name': 'No procedural videos', 'type': 'OTHER', 'description': 'No procedural videos', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Shaheed Zulfiqar Ali Bhutto Medical University/PIMS', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaheed Zulfiqar Ali Bhutto Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mansoor Ahmed', 'investigatorAffiliation': 'Shaheed Zulfiqar Ali Bhutto Medical University'}}}}