NCT07111481

Brief Summary

At the Neurosurgical Simulation and Artificial Intelligence Learning Centre, we seek to provide surgical trainees with innovative technologies that allow them to improve their surgical technical skills in risk-free environments, potentially improving patient operative outcomes. The Intelligent Continuous Expertise Monitoring System (ICEMS), a deep learning application that assesses and trains neurosurgical technical skill and provides continuous intraoperative feedback, is one such technology that may improve surgical education. Previous research has found that music can impact cognitive performance and learning outcomes. However, the effects of music on neurosurgical simulation performance-along with the associated affective-cognitive responses-remain largely unexplored. In this randomized controlled trial, medical students from four Quebec universities will be blinded and randomized to one of two groups. The control group will undergo a simulation training session without music, while the intervention arm will listen to a Mozart piano sonata during their session. The aim of this study is to determine how listening to Mozart music during surgical simulation training influences learner technical skill acquisition and transfer, as well as their emotions and cognitive load.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

August 5, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2026

Completed
Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

August 1, 2025

Last Update Submit

May 4, 2026

Conditions

Keywords

NeurosurgeryVirtual RealitySurgical SimulationMusicMozart EffectArtificial IntelligenceIntelligent Tutoring Systems

Outcome Measures

Primary Outcomes (2)

  • Intelligent Continuous Expertise Monitoring System (ICEMS) expertise score - Technical skill acquisition across practice tasks on NeuroVR simulator

    The ICEMS will continuously evaluate the trainee's performance during each practice task and calculate average expertise scores on a scale of -1.00 (novice) to 1.00 (expert). This will allow us to assess learner technical skill acquisition from the first through fifth repetitions of the practice task.

    1 day of study

  • Intelligent Continuous Expertise Monitoring System (ICEMS) expertise score - Technical skill transfer during complex realistic task on NeuroVR simulator

    The ICEMS will continuously evaluate the trainee's performance during the realistic task and calculate an average expertise score on a scale of -1.00 (novice) to 1.00 (expert). This will allow us to assess learner technical skill transfer from the practice tasks to a more complex realistic scenario.

    1 day of study

Secondary Outcomes (2)

  • Strength of emotions elicited

    1 day of study

  • Levels of cognitive load

    1 day of study

Study Arms (2)

No music group

NO INTERVENTION

20 participants allocated. Participants perform a simulated subpial brain tumor resection on the NeuroVR simulator without music while receiving verbal feedback from the ICEMS tutor.

Mozart music group

EXPERIMENTAL

20 participants allocated. Participants will listen to Mozart music while performing a simulated subpial brain tumor resection on the NeuroVR simulator and receiving verbal feedback from the ICEMS tutor.

Behavioral: Mozart music

Interventions

Mozart musicBEHAVIORAL

Participants will be played Mozart's Sonata for Two Pianos in D Major, K. 448 during their surgical simulation training session with an AI tutor.

Mozart music group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Prior use of the NeuroVR (CAE Healthcare) simulator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurosurgical Simulation and Artificial Intelligence Learning Centre

Montreal, Quebec, H2X 4B3, Canada

Location

Related Publications (9)

  • Duffy MC, Lajoie SP, Pekrun R, Lachapelle K. Emotions in medical education: Examining the validity of the Medical Emotion Scale (MES) across authentic medical learning environments. Learn Instr. 2020;70:101150. doi:10.1016/j.learninstruc.2018.07.001

    BACKGROUND
  • R Core Team. R: A Language and Environment for Statistical Computing. Vienna, Austria: R Foundation for Statistical Computing; 2025. https://www.R-project.org/

    BACKGROUND
  • Leppink J, Paas F, Van der Vleuten CP, Van Gog T, Van Merrienboer JJ. Development of an instrument for measuring different types of cognitive load. Behav Res Methods. 2013 Dec;45(4):1058-72. doi: 10.3758/s13428-013-0334-1.

    PMID: 23572251BACKGROUND
  • Winkler-Schwartz A, Bissonnette V, Mirchi N, Ponnudurai N, Yilmaz R, Ledwos N, Siyar S, Azarnoush H, Karlik B, Del Maestro RF. Artificial Intelligence in Medical Education: Best Practices Using Machine Learning to Assess Surgical Expertise in Virtual Reality Simulation. J Surg Educ. 2019 Nov-Dec;76(6):1681-1690. doi: 10.1016/j.jsurg.2019.05.015. Epub 2019 Jun 13.

    PMID: 31202633BACKGROUND
  • Liu X, Cruz Rivera S, Moher D, Calvert MJ, Denniston AK; SPIRIT-AI and CONSORT-AI Working Group. Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension. Lancet Digit Health. 2020 Oct;2(10):e537-e548. doi: 10.1016/S2589-7500(20)30218-1. Epub 2020 Sep 9.

    PMID: 33328048BACKGROUND
  • Wiseman MC. The Mozart effect on task performance in a laparoscopic surgical simulator. Surg Innov. 2013 Oct;20(5):444-53. doi: 10.1177/1553350612462482. Epub 2012 Nov 14.

    PMID: 23154636BACKGROUND
  • Nees LK, Grozinger P, Orthmann N, Rippinger N, Hennigs A, Sohn C, Domschke C, Wallwiener M, Rom J, Riedel F. The Influence of Different Genres of Music on the Performance of Medical Students on Standardized Laparoscopic Exercises. J Surg Educ. 2021 Sep-Oct;78(5):1709-1716. doi: 10.1016/j.jsurg.2021.03.008. Epub 2021 Mar 31.

    PMID: 33812805BACKGROUND
  • Rauscher FH, Shaw GL, Ky KN. Listening to Mozart enhances spatial-temporal reasoning: towards a neurophysiological basis. Neurosci Lett. 1995 Feb 6;185(1):44-7. doi: 10.1016/0304-3940(94)11221-4.

    PMID: 7731551BACKGROUND
  • Yilmaz R, Winkler-Schwartz A, Mirchi N, Reich A, Christie S, Tran DH, Ledwos N, Fazlollahi AM, Santaguida C, Sabbagh AJ, Bajunaid K, Del Maestro R. Continuous monitoring of surgical bimanual expertise using deep neural networks in virtual reality simulation. NPJ Digit Med. 2022 Apr 26;5(1):54. doi: 10.1038/s41746-022-00596-8.

    PMID: 35473961BACKGROUND

Study Officials

  • Rolando F. Del Maestro, MD, PhD

    Neurosurgical Simulation and Artificial Intelligence Learning Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Study participants are blinded to group assignments and study outcomes.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neurosurgical Simulation and Artificial Intelligence Learning Centre

Study Record Dates

First Submitted

August 1, 2025

First Posted

August 8, 2025

Study Start

August 5, 2025

Primary Completion

March 14, 2026

Study Completion

March 14, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Data obtained from primary and secondary outcomes may be shared if other researchers have an interest in this data.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available for 5 years following the completion of the trial.
Access Criteria
Researchers who wish to access the data must contact the principal investigator of the trial, Dr. Rolando F. Del Maestro.

Locations