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Surgical EducationNCT07111481

Effect of Music on Surgical Performance During Artificial Intelligence-Based Simulation Training

A study testing Mozart music exposure in people with Surgical Education, run by McGill University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Surgical Education
What is being tested?
Mozart music exposure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
1 siteCanada
Study dates
5 Aug 2025to 14 Mar 2026
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Medical students who are actively enrolled in their preparatory, first, second year of medical school at any Quebec institution who do not fit the exclusion criteria.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Neurosurgical Simulation and Artificial Intelligence Learning Centre

    Montreal, Quebec, H2X 4B3

Other trials in Canada

About this study

Official title: Effect of Music on Surgical Performance During Artificial Intelligence-Based Simulation Training: A Randomized Controlled Trial

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 4 Quebec universities will be blinded and randomized to 1 of 2 groups. The control group will undergo a simulation training session without music, while the intervention arm will be exposed to a Mozart piano sonata during their session. The aim of this study is to determine how Mozart music exposure during surgical simulation training influences learner technical skill acquisition and transfer, as well as their emotions, stress states, and cognitive load.

Read the detailed description

Background: The Intelligent Continuous Expertise Monitoring System (ICEMS) is a deep learning application that was developed at the Neurosurgical Simulation and Artificial Intelligence Learning Centre to improve neurosurgical education. The ICEMS assesses and trains bimanual surgical performance by providing continuous feedback via verbal instructions in order to improve trainee performance and mitigate errors. At present, how learners respond to music during surgical training with the ICEMS is unknown.

Rationale: The Mozart effect refers to the short-term enhancement in spatial-temporal reasoning that occurs in learners when they listen to Mozart music. Previous studies have found that exposure to Mozart and/or classical music before or during surgical simulation training can lead to improved performance. However, these studies did not involve a structured artificial intelligence (AI)-enhanced curriculum or objective, quantitative performance assessment based on AI-derived metrics. Moreover, these studies have not assessed how exposure to music during surgical simulation training influences learners' affective-cognitive states.

This report follows the Consolidated Standards of Reporting Trials-Artificial Intelligence (CONSORT-AI).

Hypotheses:

  1. Exposure to a Mozart piano sonata during surgical simulation training will result in superior skill acquisition and transfer in trainees compared with no music.
  2. Exposure to a Mozart piano sonata during surgical simulation training will result in lower levels of negative emotions, stress, and cognitive load compared with no music.

Primary Objectives: To determine how exposure to Mozart music during surgical simulation training influences trainee:

  1. Trainee technical skill acquisition and overall surgical performance (composite expertise scores across all practice tasks calculated by the ICEMS).
  2. Trainee skill transfer to a more complex realistic scenario (composite expertise scores during realistic task calculated by the ICEMS).

Secondary Objective: To determine how exposure to Mozart music during surgical simulation training influences trainee affective-cognitive responses, including emotions (self-reported via questionnaires administered before, during, and after each training session using the Medical Emotion Scale [MES] on 7-point Likert scales), stress states (self-reported via questionnaires administered before, during, and after each training session using the Short Stress State Questionnaire [SSSQ] on 5-point Likert scales), and cognitive load (self-reported via questionnaire administered after each training session using the Cognitive Load Index [CLI] on 5-point Likert scales).

Setting: McGill University's Neurosurgical Simulation and Artificial Intelligence Learning Centre.

Participants: Students enrolled in their preparatory, first, or second year at 1 of the 4 Quebec medical schools.

Design: A single-blinded 2-arm randomized controlled trial.

Intervention: Participants will undergo a single training session of approximately 90 minutes on the NeuroVR (CAE Healthcare), a virtual reality (VR) surgical simulator that simulates a subpial brain tumor resection. In this study, participants will perform 2 different scenarios on the NeuroVR: a simple practice scenario and a complex realistic scenario. During the session, participants will perform 5 repetitions of the practice scenario (5 minutes each) followed by the realistic scenario (13 minutes). The ICEMS will continuously assess performance throughout the trials.

Group 1 (control) will complete their training session without music. Group 2 will be exposed to Mozart's Sonata for Two Pianos in D Major, K. 448 during their training session.

Verbal feedback will be based on the following metrics:

  1. Tissue injury risk: When a trainee receives feedback on this metric, the healthy brain tissue has been damaged or is at risk of being damaged.
  2. Bleeding risk: When a trainee receives feedback on this metric, there is bleeding that must be cauterized or a risk of bleeding.
  3. Instrument tip separation distance: Refers to the distance between the tip of the ultrasonic aspirator and the tips of the bipolar forceps. When a trainee receives feedback on this metric, their instruments are too far apart.
  4. High bipolar force: Refers to the amount of force applied to the tissue by the bipolar forceps. When a trainee receives feedback on this metric, they are applying too much force with the bipolar.
  5. Low bipolar force: Refers to the amount of force applied to the tissue by the bipolar forceps. When a trainee receives feedback on this metric, they are not applying enough force with the bipolar.
  6. High aspirator force: Refers to the amount of force applied to the tissue by the ultrasonic aspirator. When a trainee receives feedback on this metric, they are applying too much force with the aspirator.

These metrics will continuously be evaluated by the ICEMS. The ICEMS will only provide feedback on 1 metric at a time according to a predetermined hierarchy (in the order listed above). For example, if the ICEMS detects on error on both bleeding risk (2) and high aspirator force (6) at the same time, the system will only provide feedback on bleeding risk since this metric is above high aspirator force in the hierarchy.

Study Procedure: Prior to the simulation session, the study coordinator will stratify participants according to their year in medical school and block randomize them to 1 of 3 intervention arms with an allocation ratio of 1:1. Upon arrival, participants will read and sign an informed consent form. They will then fill out a pre-trial questionnaire recording demographic information and self-reported baseline emotions (MES) and stress states (SSSQ). Trial instructions introducing the NeuroVR simulator, the instruments, and the practice subpial resection scenario will be provided via a written document. Each practice task will last 5 minutes, followed by a 5-minute rest period. No post-hoc feedback will be provided during the rest periods. Participants will perform their first practice task without feedback to establish a baseline. Participants will then perform their second through fifth practice tasks while receiving metric-specific verbal feedback from the ICEMS. During these formative practice tasks, music will be turned on for the experimental group and paused during the rest periods. Following the completion of the practice tasks, participants will complete a peri-trial questionnaire to assess their emotions (MES) and stress states (SSSQ). They will be provided with another information document introducing the realistic subpial brain tumor resection task. Participants will complete the 13-minute realistic task to assess their skill transfer to a more complex scenario. Finally, they will fill out a post-trial questionnaire assessing their emotions (MES), stress states (SSSQ), and cognitive load (CLI).

Being tested
Mozart music exposure
Keywords
Neurosurgery, Virtual Reality, Surgical Simulation, Music, Mozart Effect, Artificial Intelligence, Intelligent Tutoring Systems

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mozart music exposureBehavioural

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

Study groups in NCT07111481
Study groupRoleWhat they receive
No music groupNo intervention50 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 groupExperimental47 participants allocated. Participants will be exposed to Mozart music while performing a simulated subpial brain tumor resection on the NeuroVR simulator and receiving verbal feedback from the ICEMS tutor.
Receives: Behavioral: Mozart music exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 day of study

  2. 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.

    Measured: 1 day of study

Secondary outcomes (3)
  1. Emotions

    Measured using Duffy's Medical Emotion Scale (MES) before, during, and after the training session (self-reported via questionnaires on 7-point Likert scales).

    Measured: 1 day of study

  2. Stress states

    Measured using Helton's Short Stress State Questionnaire (SSSQ) before, during, and after the training session (self-reported via questionnaires on 5-point Likert scales).

    Measured: 1 day of study

  3. Cognitive load

    Measured using Leppink's Cognitive Load Index (CLI) after the training session (self-reported via questionnaire on 5-point Likert scales).

    Measured: 1 day of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study start5 Aug 2025
  3. Primary completion14 Mar 2026
  4. Study completion14 Mar 2026

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Single blind
Who is masked
Participant
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07111481
Sponsor's protocol ID
2010-270, NEU-09-042-Trial 6
Status last verified
Jul 2026
First submitted
1 Aug 2025
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data obtained from primary and secondary outcomes may be shared if other researchers have an interest in this data.

Publications

  • 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

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

  • 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.

    PubMed 23572251
  • 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.

    PubMed 33328048
  • 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.

    PubMed 23154636
  • 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.

    PubMed 33812805
  • 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.

    PubMed 7731551
  • 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.

    PubMed 35473961

Questions about this trial

What is this clinical trial studying?

A study testing Mozart music exposure in people with Surgical Education, run by McGill University at 1 site in Canada.

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 1 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 23 Jul 2026. 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 Canada. 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?

Intelligent Continuous Expertise Monitoring System (ICEMS) expertise score - Technical skill acquisition across practice tasks on NeuroVR simulator (time frame: 1 day of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07111481, which also lists 8 linked publications.

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 23 Jul 2026.

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