300 Students of University of Milan School of MedicinePASSIONNCT06792669
Psychological Assessment and Skills Training by Simulation in Neurosurgery
A study testing Simulation training to evaluate the participants' manual skill improvement in people with 300 Students of University of Milan School of Medicine, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- 300 Students of University of Milan School of Medicine
- What is being tested?
- Simulation training to evaluate the participants' manual skill improvement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 31 May 2015to 31 Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 5th - 6th year medical students.
- Signed informed consent.
Who cannot join
- Medical students with any previous surgical experience or simulation training (mechanical, PC-based and/or others).
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Istituto neurologico Carlo Besta
Milan, Milan, 20133
About this study
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.
- Being tested
- Simulation training to evaluate the participants' manual skill improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation training to evaluate the participants' manual skill improvementOther
| Study group | Role | What they receive |
|---|---|---|
| Neurosimulation training | Experimental | 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 Receives: Other: Simulation training to evaluate the participants' manual skill improvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulation training
Changes in performances at surgical tasks after a simulation training
Measured: 4 weeks
Secondary outcomes (3)
Psychological assessment
Correlation between cognitive and psycho-attitudinal test and improvement at manual/surgical tasks
Measured: 4 weeks
Spatial assessment
Correlation between tests' results for the visual-spatial ability assessment and the best performances at manual-surgical tasks
Measured: 4 weeks
Career path
Correlation between performances at real/simulated tasks and students' education/career path
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start31 May 2015
- Primary completion31 Aug 2015
- Study completion31 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 300 Students of University of Milan School of MedicineStudies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan
- Responsible party
- Sponsor
- Investigators
- Francesco DiMeco, MD, Study chair, Fondazione Irccs Istituto Neurologico Carlo Besta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792669
- Sponsor's protocol ID
- 20150317
- Acronym
- PASSION
- Status last verified
- Jan 2025
- First submitted
- 17 Mar 2015
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Assessment and Skills Training by Simulation in Neurosurgery
- ClinicalTrials.gov ID
- NCT06792669
- Acronym / sponsor ID
- PASSION / 20150317
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Collaborators
- University of Milan
- Study start
- 31 May 2015 (actual)
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 31 Oct 2015 (actual)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurosimulation training | Experimental | Other: Simulation training to evaluate the participants' manual skill improvementPsychological 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 5th - 6th year medical students.
- Signed informed consent.
Key exclusion criteria (1 listed)
- Medical students with any previous surgical experience or simulation training (mechanical, PC-based and/or others).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation training to evaluate the participants' manual skill improvement | Other | Neurosimulation training |
Primary outcome
Simulation training
Time frame: 4 weeks
Changes in performances at surgical tasks after a simulation training
3 secondary outcomes
Psychological assessment
Time frame: 4 weeks
Spatial assessment
Time frame: 4 weeks
Career path
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco DiMeco, MD study chair
Fondazione Irccs Istituto Neurologico Carlo Besta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation training to evaluate the participants' manual skill improvement in people with 300 Students of University of Milan School of Medicine, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simulation training (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.