Psychological Assessment and Skills Training by Simulation in Neurosurgery (PASSION)

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.

Study Overview

• Status: Completed
• Conditions: 300 Students of University of Milan School of Medicine
• Intervention / Treatment: Other: Simulation training to evaluate the participants' manual skill improvement

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Neurologico Carlo Besta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 5th - 6th year medical students.
• Signed informed consent.

Exclusion Criteria:

• Medical students with any previous surgical experience or simulation training (mechanical, PC-based and/or others).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Neurosimulation training; 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

Other: Simulation training to evaluate the participants' manual skill improvement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Simulation training	Changes in performances at surgical tasks after a simulation training	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological assessment	Correlation between cognitive and psycho-attitudinal test and improvement at manual/surgical tasks	4 weeks
Spatial assessment	Correlation between tests' results for the visual-spatial ability assessment and the best performances at manual-surgical tasks	4 weeks
Career path	Correlation between performances at real/simulated tasks and students' education/career path	up to 3 years

Collaborators and Investigators

• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Collaborators: University of Milan
• Investigators: Study Chair: Francesco DiMeco, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2015
• Primary Completion (Actual): August 31, 2015
• Study Completion (Actual): October 31, 2015

Study Registration Dates

• First Submitted: March 17, 2015
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 20150317

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No