Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-30 @ 2:45 AM
Study NCT ID:
NCT06792669
Status:
COMPLETED
Last Update Posted:
2025-01-27
First Post:
2015-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Assessment and Skills Training by Simulation in Neurosurgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2015-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2015-03-17', 'studyFirstSubmitQcDate': '2025-01-21', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Simulation training', 'timeFrame': '4 weeks', 'description': 'Changes in performances at surgical tasks after a simulation training'}], 'secondaryOutcomes': [{'measure': 'Psychological assessment', 'timeFrame': '4 weeks', 'description': 'Correlation between cognitive and psycho-attitudinal test and improvement at manual/surgical tasks'}, {'measure': 'Spatial assessment', 'timeFrame': '4 weeks', 'description': "Correlation between tests' results for the visual-spatial ability assessment and the best performances at manual-surgical tasks"}, {'measure': 'Career path', 'timeFrame': 'up to 3 years', 'description': "Correlation between performances at real/simulated tasks and students' education/career path"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['300 Students of University of Milan School of Medicine']}, 'descriptionModule': {'briefSummary': 'The subject of Safety in Health is assuming in time a predominant position with those of high social, economic and political relevance. Numerous medical-surgical procedures are frequently learned as they are performed directly on the patient. The scope of our research, hence, is to recruit 5th- and 6th-year students of Medicine of the University of Milan who will have the opportunity to use two state-of-the-art 3-D virtual reality neurosurgical simulators at the Besta NeuroSim Center. Psychological Evaluation instruments will be used in order to select the personality profile most fit for a career in neurosurgery and to understand what training method is the most appropriate to achieve the best results in neurosurgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 5th - 6th year medical students.\n* Signed informed consent.\n\nExclusion Criteria:\n\n• Medical students with any previous surgical experience or simulation training (mechanical, PC-based and/or others).'}, 'identificationModule': {'nctId': 'NCT06792669', 'acronym': 'PASSION', 'briefTitle': 'Psychological Assessment and Skills Training by Simulation in Neurosurgery', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta'}, 'officialTitle': 'Psychological Assessment and Skills Training by Simulation in Neurosurgery', 'orgStudyIdInfo': {'id': '20150317'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurosimulation training', 'description': 'Psychological tests will be administered to the participants aiming at analyzing the psychological profile, the visual-spatial skills, and the manual skills of the medical students. 60 students (under the 10% and over 90% at the tests) - out of a total of 300 students recruited - will be asked to perform 2 medical-surgical tasks (performing an apple debulking by means of a surgical ultrasonic aspirator at the operative microscope and a lumbar puncture on a dedicated manikin); performances will be recorded and rated by experts surgeons. Participants will then perform a microsurgery-training program, by means of specific neurosurgical simulators (Immersive Touch and NeuroTouch) for a defined period of time. Their performances will be recorded and rated by the simulators automatically. After the end of the simulation training program, students will repeat the tasks at the operative microscope and at lumbar puncture manikin, in order to evaluate and quantify their manual skill improvement', 'interventionNames': ["Other: Simulation training to evaluate the participants' manual skill improvement"]}], 'interventions': [{'name': "Simulation training to evaluate the participants' manual skill improvement", 'type': 'OTHER', 'armGroupLabels': ['Neurosimulation training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20133', 'city': 'Milan', 'state': 'Milan', 'country': 'Italy', 'facility': 'Fondazione IRCCS Istituto neurologico Carlo Besta', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Francesco DiMeco, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fondazione Irccs Istituto Neurologico Carlo Besta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Milan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}