Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-29 @ 8:11 AM
Study NCT ID:
NCT06571903
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video-based Learning for Basic Surgical Skills
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-08-22', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the qualities of the techniques (Objective Structured Assessment of Technical Skills (OSATS) modified scale)', 'timeFrame': '2 weeks', 'description': 'Evaluate the quality of execution of the technical gesture and its retention on each group (teaching basic surgical techniques through video and traditional education (courses face-to-face)). The Objective Structured Assessment of Technical Skills (OSATS) modified scale is scored from 8 (worst performance) to 40 (best performance).'}, {'measure': 'Time the participants took to complete the procedure', 'timeFrame': '2 weeks', 'description': 'Time in minutes and seconds (mm:ss) that the participants took to complete the procedure on each group (teaching basic surgical techniques through video and traditional education (courses face-to-face)).'}], 'secondaryOutcomes': [{'measure': "Assessment of participants' involvement and interest (time of self-study in hours)", 'timeFrame': '1 month', 'description': "Time of self-study in hours and minutes (hh:mm), to check participants' involvement and interest in the teaching method through video."}, {'measure': 'Participant satisfaction with teaching method (Likert-like satisfaction questionnaire)', 'timeFrame': '1 day', 'description': 'Likert-like satisfaction questionnaire scored from 5 (worst outcome) to 25 (best outcome).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Video-based Learning', 'Basic Surgical Skills', 'mOSATS', 'Surgical Education', 'Teaching Methods'], 'conditions': ['Teaching Basic Surgical Techniques']}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized study, intended to evaluate the effectiveness of teaching basic surgical techniques through video, comparing the results with those of traditional teaching'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Students from the 1st to 3rd years of the Integrated Master's Degree in Medicine at the University of Porto,\n* Able to participate in a course of basic surgical techniques (simple suturing, X-stitches, U-stitches and Donatti points)\n\nExclusion Criteria:\n\n* Participants is to have had prior contact with techniques surgical and/or minor surgery,\n* Participants had contact with techniques surgical and/or minor surgery in the period between recruitment and completion of the proposed learning"}, 'identificationModule': {'nctId': 'NCT06571903', 'briefTitle': 'Video-based Learning for Basic Surgical Skills', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Video-based Learning for Basic Surgical Skills - a Randomized Trial', 'orgStudyIdInfo': {'id': 'VBSS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Traditional Learning', 'description': 'Teaching with an expert tutor, in a in-person course'}, {'type': 'EXPERIMENTAL', 'label': 'Video-based Learning', 'description': 'Teaching with videos for autonomous learning and practice', 'interventionNames': ['Other: Teaching from videos']}], 'interventions': [{'name': 'Teaching from videos', 'type': 'OTHER', 'description': 'Teaching from videos for independent study', 'armGroupLabels': ['Video-based Learning']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto', 'country': 'Portugal', 'facility': 'Faculty of Medicine of University of Porto', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'overallOfficials': [{'name': 'Vitor Lopes, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine of University of Porto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro Hospitalar De São João, E.P.E.', 'class': 'OTHER'}, {'name': 'Rede de Investigação em Saúde', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}