Surgical EducationNCT06235788
Effect of Intelligent Tutor Induced Pausing on Learning Simulated Surgical Skills
A study testing Experimental Group ICEMS verbal feedback with pause group and Experimental Group ICEMS audio feedback with pause and expert video in people with Surgical Education, run by McGill University at 1 site in Canada.
Trial summary
Traditional training of surgical technical skills relies on mentorship from experienced surgeons, who continuously evaluate and change trainee performance to prevent errors and potential patient harm by providing verbal instructions. 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?
- Experimental Group ICEMS verbal feedback with pause group and Experimental Group ICEMS audio feedback with pause and expert video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2024to Sep 2024
- 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
- First and second year medical students who are actively enrolled in any Quebec institution who do not meet the exclusion criteria.
- Students actively enrolled in medical school in a preparatory year in any Quebec institution who do not meet the exclusion criteria.
Who cannot join
- Participation in previous trials involving the NeuroVR (CAE Healthcare) simulator
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Neurosurgical Simulation and Artificial Intelligence Learning Centre
Montreal, Quebec, H2X 4B3
Rolando F Del Maestro, MD, PhD, 519 708 0346, rolando.del_maestro@mcgill.ca
Vanja Davidovic, 6132964855, vanja.davidovic@mail.mcgill.ca
About this study
Official title: Effect of Intelligent Tutor Induced Pausing on Learning Simulated Surgical Skills Among Medical Students: A Randomized Controlled Trial
Traditional training of surgical technical skills relies on mentorship from experienced surgeons, who continuously evaluate and change trainee performance to prevent errors and potential patient harm by providing verbal instructions. These educators may also pause the procedure, explaining the risks associated with the trainee's actions, and may personally demonstrate proper techniques to the students. Studies examining pausing while providing medical care outline that these approaches allow for learning.
An artificial intelligent (AI) tutoring system, the Intelligent Continuous Expertise Monitoring System (ICEMS), improves learning in a surgical simulated operation by providing trainees with verbal instructions upon error identification. However, the effect of including a pause during this AI teaching has not been studied. Therefore, the ICEMS post-error identification methodology has been altered to include a pause with the intelligent tutor voice instruction.
The aim of this study is to determine the effect of pausing on surgical skill acquisition and transfer among pre-medical and medical students. This will be done by comparing their performance in repeated simulated tumour resection tasks.
Read the detailed description
Background: Surgical skill assessment is shifting from a quantitative, time-based approach towards a qualitative evaluation of a trainee's competency. During surgical procedures, instructors continuously monitor trainee performance and utilize various teaching methods focused on enhancing acquisition of surgical skills. One such method includes pausing the operation, either to outline the risks associated with the trainee's performance or to personally demonstrate the best practice technique(s). Pausing in such situations has been shown to allow learners to re-assess best practice, interrupt negative momentum, and allow for learning. Specifically, pausing after an error can prevent introduction of new information that may affect one's ability to reflect on their error and reduce stress before continuing.
Rationale: The ICEMS, an AI tutoring system, was developed by our group using a Long-Short Term Memory deep learning algorithm to assess surgical performance and provide guidance. This was then integrated with the NeuroVR simulation platform. Using this AI system, the provision of verbal feedback on error identification demonstrated the potential of intelligent tutoring to improve learning in two previous randomized control trials (RCTs). However, these RCTs did not incorporate pausing methodology post-error identification. To further emulate the mentorship of an experienced surgeon in a clinical setting, the ICEMS platform has been modified to both initiate pausing when learner error is identified and provide a video demonstrating expert performance.
Research aims: To compare the effect of incorporating a pause after intelligent tutor instruction to intelligent tutor instruction alone on medical and pre-medical students' surgical skill acquisition and skill transfer.
Hypotheses:
- The pause with video group will significantly improve the composite score between the first and sixth repetition of the practice scenario.
- The pause with video group will have a composite score statistically higher than the control group in the sixth repetition of the practice scenario.
- The pause with video group will have a composite score statistically non-inferior to the pause without video group in the sixth repetition of the practice scenario.
- The pause with video group will have a global OSATS score statistically higher than the control group in the realistic scenario.
- The pause with video group will have a global OSATS score statistically non-inferior to the pause without video group in the realistic scenario.
- The pause with video group will not elect a difference in emotional stress or cognitive load compared to the control group.
Specific objectives:
- To assess if the efficacy of AI mediated real-time tailored feedback combined with pausing methodology is statistically superior to AI mediated real-time tailored feedback alone in improving medical students' surgical skills on two virtual reality surgery tasks.
- To determine if different emotions and cognitive load are elicited by the pausing methodology as compared to only hearing the AI mediated feedback.
Design: A three-arm single blinded randomized controlled trial of AI feedback with pausing methodology and an expert demonstration video versus AI feedback with only pausing methodology versus AI feedback alone.
Setting: Neurosurgical Simulation and Artificial Intelligence Learning Centre.
Participants: Students who are enrolled in a Quebec medical school in a preparatory year, and first and second year.
Task: Using the NeuroVR surgical simulator by CAE Healthcare, resect a simulated practice tumour six times and a complex simulated realistic brain tumour once using an Ultrasonic Aspirator and Bipolar pincers while minimizing bleeding and preserving the surrounding, simulated healthy brain structures.
Intervention: A 90-minute training session where participants will have seven simulated subpial tumour resection attempts (six repetitions of a simple practice scenario and one attempt at a complex realistic scenario). All participants will receive auditory feedback from the ICEMS but will differ in what follows:
- Continuously perform the procedure (i.e., no pause) (Group 1);
- A pause followed by a reflection period (Group 2);
- A pause followed by an expert-level demonstration video and a reflection period (Group 3).
Auditory feedback will be based on 4 metrics:
- Instrument tip separation distance;
- Low bipolar force;
- High aspirator force;
- High bipolar force. Initially, feedback will only be given based on the first metric (instrument tip separation), but once a repetition is completed without receiving feedback, the subsequent repetition will assess the next metric in the list above, and so on and so forth.
Main outcomes and measures:
The two co-primary outcomes are:
- The improvement in surgical performance, as dictated by the composite score computed by the previously validated evaluation module of the ICEMS. Performance improvement is measured by the difference in composite score between each of the 6 repetitions of the practice scenario. Transfer of learning will be measured by the participant's composite score for the complex realistic scenario.
- The performance score of the participants in the complex realistic scenario, assessed by two blinded experts using the Objective Structured Assessment of Technical Skills (OSATS) global rating scale.
The secondary outcome is the differences in the strength of emotions elicited, measured before the practice scenario, immediately before the realistic scenario, and after completion of all attempts using the Duffy's Medical Emotional Scale (MES). Cognitive load will also be measured following completion of all tasks using Leppink's Cognitive Load Index (CLI). Both outcomes are measured using self-reports.
Statistical Analysis Plan: Participant data will be anonymized and stored. The ICEMS will assess the participant's surgical performance and provide a performance score at 0.2 second intervals throughout each repetition of the simulated surgical task. An average composite score will then be calculated for each repetition. Using ANCOVA, improvement in performance and participant learning will be assessed by comparing the composite score of the first practice scenario repetition (baseline) and the composite score of the sixth repetition (summative). Meanwhile, the composite score of the complex realistic scenario will be used to assess the transfer of learning using a one-way ANOVA. With an effect size of 0.25 and a significance of 0.05, a total sample size of 129 provides 80% power to detect a significant interaction.
Videos of participant performance in the complex realistic scenario will be evaluated by two blinded expert raters using the OSATS global rating scale. The OSATS score will be analyzed between groups using a one-way ANOVA to compare efficiency of learning and skill retention.
Emotional changes before, during, and after learning in the simulated scenarios will be evaluated using a two-way mixed ANOVA, while one-way ANOVA will be used to assess cognitive load after learning.
- Conditions
- Surgical Education
- Being tested
- Experimental Group ICEMS verbal feedback with pause group, Experimental Group ICEMS audio feedback with pause and expert video
- Keywords
- Artificial intelligence, Intelligent tutor, Clinical trial, Medical students, Competency-based feedback, Neurosurgery, Virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Group ICEMS verbal feedback with pause groupBehavioural
While performing the simulated procedure, if participants receive real-time verbal feedback based on the intelligent system error detection, they will be instructed to pause the task, putting their instruments down and reflecting for 22 seconds. A warning will be given when there are 7 seconds remaining in the reflection period so individuals can prepare to resume the task immediately.
Experimental Group ICEMS audio feedback with pause and expert videoBehavioural
While performing the simulated procedure, if participants receive real-time verbal feedback based on the intelligent system error detection, they will be instructed to pause the task, putting their instruments down, turning their attention to a 9-second expert-level demonstration video, and reflecting for 13 seconds. A warning will be given when there are 7 seconds remaining in the reflection period so individuals can prepare to resume the task immediately.
| Study group | Role | What they receive |
|---|---|---|
| Control Group Intelligent Continuous Expertise Monitoring System (ICEMS) only verbal feedback group | No intervention | 43 participants. Individuals receive standard information. They perform 6 5-min practice scenario resections with a 5-min break between each one. The 7th attempt is the 13-min realistic scenario. Participants receive no feedback during the first repetition. They will then receive feedback on 4 metrics, one metric a time: instrument tip separation, low bipolar force, high aspirator force, high bipolar force. Once an attempt is completed without receiving feedback, the next repetition will assess the next metric in the list above. During the 5-min break after an attempt is completed without receiving feedback, participants can watch an optional expert-level demonstration video corresponding to the next metric. Participants receive no feedback during the 6th repetition. They will have no feedback in their 7th repetition, the realistic scenario. |
| Experimental Group ICEMS verbal feedback with pause group | Experimental | 43 participants. Individuals receive standard information. They perform 6 5-min practice scenario resections with a 5-min break between each one. The 7th attempt is the 13-min realistic scenario.
Participants receive no feedback during the first repetition. They will then receive feedback on 4 metrics, one metric a time: instrument tip separation, low bipolar force, high aspirator force, high bipolar force. Once an attempt is completed without receiving feedback, the next repetition will assess the next metric in the list above. During the 5-min break after an attempt is completed without receiving feedback, participants can watch an optional expert-level demonstration video corresponding to the next metric. Participants receive no feedback during the 6th repetition. They will have no feedback in their 7th repetition, the realistic scenario. Receives: Behavioral: Experimental Group ICEMS verbal feedback with pause group |
| Experimental Group ICEMS verbal feedback with pause and expert-level video demonstration | Experimental | 43 participants. Individuals receive standard information. They perform 6 5-min practice scenario resections with a 5-min break between each one. The 7th attempt is the 13-min realistic scenario.
Participants receive no feedback during the first repetition. They will then receive feedback on 4 metrics, one metric a time: instrument tip separation, low bipolar force, high aspirator force, high bipolar force. Once an attempt is completed without receiving feedback, the next repetition will assess the next metric in the list above. During the 5-min break after an attempt is completed without receiving feedback, participants can watch an optional expert-level demonstration video corresponding to the next metric. Participants receive no feedback during the 6th repetition. They will have no feedback in their 7th repetition, the realistic scenario. Receives: Behavioral: Experimental Group ICEMS audio feedback with pause and expert video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance
Evaluated by comparing the average composite-score, calculated by the ICEMS, from each practice scenario. Scores range from expert/skilled level (a score of 1.00) to novice/less-skilled level (a score of -1.00).
Measured: 1 day of study
Transfer of learning
Evaluated by comparing the average composite-score, calculated by the ICEMS, from each practice scenario. Scores range from expert/skilled level (a score of 1.00) to novice/less-skilled level (a score of -1.00).
Measured: 1 day of study
Objective Structured Assessment of Technical Skills (OSATS) global rating scale
Performance score of the participants in the complex realistic scenario, assessed by two blinded experts using the Objective Structured Assessment of Technical Skills (OSATS) global rating scale on a 7-point Likert scale (1= novice to 7 = expert). Efficacy in learning with pausing methodology and an expert-level demonstration video will be compared to pausing methodology alone and to no pausing methodology.
Measured: 1 day of study
Secondary outcomes (2)
Differences in strength of emotions elicited
Measured by Duffy's Medical Emotional Scale (MES) before, during, and after learning. Participants will self-report the intensity of each emotion on a 5-point Likert scale (1 = not at all to 5 = very strong).
Measured: 1 day of study
Difference in Cognitive Load
Measured using Leppink's Cognitive Load Index (CLI) after the intervention. Participants will self-report their level of agreement with each statement on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree).
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.
- First posted1 Feb 2024
- Study start30 Jan 2024
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Surgical EducationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolando Del Maestro, McGill University
- Investigators
- Rolando F Del Maestro, MD, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235788
- Sponsor's protocol ID
- 2010-270, NEU-09-042-Trial 4
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 5 Feb 2024
- 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
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 35473961Fazlollahi AM, Bakhaidar M, Alsayegh A, Yilmaz R, Winkler-Schwartz A, Mirchi N, Langleben I, Ledwos N, Sabbagh AJ, Bajunaid K, Harley JM, Del Maestro RF. Effect of Artificial Intelligence Tutoring vs Expert Instruction on Learning Simulated Surgical Skills Among Medical Students: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2149008. doi: 10.1001/jamanetworkopen.2021.49008.
PubMed 35191972Winkler-Schwartz A, Yilmaz R, Mirchi N, Bissonnette V, Ledwos N, Siyar S, Azarnoush H, Karlik B, Del Maestro R. Machine Learning Identification of Surgical and Operative Factors Associated With Surgical Expertise in Virtual Reality Simulation. JAMA Netw Open. 2019 Aug 2;2(8):e198363. doi: 10.1001/jamanetworkopen.2019.8363.
PubMed 31373651Lee JY, Szulewski A, Young JQ, Donkers J, Jarodzka H, van Merrienboer JJG. The medical pause: Importance, processes and training. Med Educ. 2021 Oct;55(10):1152-1160. doi: 10.1111/medu.14529. Epub 2021 May 1.
PubMed 33772840
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intelligent Tutor Induced Pausing on Learning Simulated Surgical Skills Among Medical Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06235788
- Acronym / sponsor ID
- 2010-270, NEU-09-042-Trial 4
- Conditions
- Surgical Education
- Keywords
- Artificial intelligence, Intelligent tutor, Clinical trial, Medical students, Competency-based feedback, Neurosurgery, Virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 1 Feb 2024 (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.
Traditional training of surgical technical skills relies on mentorship from experienced surgeons, who continuously evaluate and change trainee performance to prevent errors and potential patient harm by providing verbal instructions. These educators may also pause the procedure, explaining the risks associated with the trainee's actions, and may personally demonstrate proper techniques to the students. Studies examining pausing while providing medical care outline that these approaches allow for learning.
An artificial intelligent (AI) tutoring system, the Intelligent Continuous Expertise Monitoring System (ICEMS), improves learning in a surgical simulated operation by providing trainees with verbal instructions upon error identification. However, the effect of including a pause during this AI teaching has not been studied. Therefore, the ICEMS post-error identification methodology has been altered to include a pause with the intelligent tutor voice instruction.
The aim of this study is to determine the effect of pausing on surgical skill acquisition and transfer among pre-medical and medical students. This will be done by comparing their performance in repeated simulated tumour resection tasks.
Detailed description
Background: Surgical skill assessment is shifting from a quantitative, time-based approach towards a qualitative evaluation of a trainee's competency. During surgical procedures, instructors continuously monitor trainee performance and utilize various teaching methods focused on enhancing acquisition of surgical skills. One such method includes pausing the operation, either to outline the risks associated with the trainee's performance or to personally demonstrate the best practice technique(s). Pausing in such situations has been shown to allow learners to re-assess best practice, interrupt negative momentum, and allow for learning. Specifically, pausing after an error can prevent introduction of new information that may affect one's ability to reflect on their error and reduce stress before continuing.
Rationale: The ICEMS, an AI tutoring system, was developed by our group using a Long-Short Term Memory deep learning algorithm to assess surgical performance and provide guidance. This was then integrated with the NeuroVR simulation platform. Using this AI system, the provision of verbal feedback on error identification demonstrated the potential of intelligent tutoring to improve learning in two previous randomized control trials (RCTs). However, these RCTs did not incorporate pausing methodology post-error identification. To further emulate the mentorship of an experienced surgeon in a clinical setting, the ICEMS platform has been modified to both initiate pausing when learner error is identified and provide a video demonstrating expert performance.
Research aims: To compare the effect of incorporating a pause after intelligent tutor instruction to intelligent tutor instruction alone on medical and pre-medical students' surgical skill acquisition and skill transfer.
Hypotheses:
- The pause with video group will significantly improve the composite score between the first and sixth repetition of the practice scenario.
- The pause with video group will have a composite score statistically higher than the control group in the sixth repetition of the practice scenario.
- The pause with video group will have a composite score statistically non-inferior to the pause without video group in the sixth repetition of the practice scenario.
- The pause with video group will have a global OSATS score statistically higher than the control group in the realistic scenario.
- The pause with video group will have a global OSATS score statistically non-inferior to the pause without video group in the realistic scenario.
- The pause with video group will not elect a difference in emotional stress or cognitive load compared to the control group.
Specific objectives:
- To assess if the efficacy of AI mediated real-time tailored feedback combined with pausing methodology is statistically superior to AI mediated real-time tailored feedback alone in improving medical students' surgical skills on two virtual reality surgery tasks.
- To determine if different emotions and cognitive load are elicited by the pausing methodology as compared to only hearing the AI mediated feedback.
Design: A three-arm single blinded randomized controlled trial of AI feedback with pausing methodology and an expert demonstration video versus AI feedback with only pausing methodology versus AI feedback alone.
Setting: Neurosurgical Simulation and Artificial Intelligence Learning Centre.
Participants: Students who are enrolled in a Quebec medical school in a preparatory year, and first and second year.
Task: Using the NeuroVR surgical simulator by CAE Healthcare, resect a simulated practice tumour six times and a complex simulated realistic brain tumour once using an Ultrasonic Aspirator and Bipolar pincers while minimizing bleeding and preserving the surrounding, simulated healthy brain structures.
Intervention: A 90-minute training session where participants will have seven simulated subpial tumour resection attempts (six repetitions of a simple practice scenario and one attempt at a complex realistic scenario). All participants will receive auditory feedback from the ICEMS but will differ in what follows:
- Continuously perform the procedure (i.e., no pause) (Group 1);
- A pause followed by a reflection period (Group 2);
- A pause followed by an expert-level demonstration video and a reflection period (Group 3).
Auditory feedback will be based on 4 metrics:
- Instrument tip separation distance;
- Low bipolar force;
- High aspirator force;
- High bipolar force. Initially, feedback will only be given based on the first metric (instrument tip separation), but once a repetition is completed without receiving feedback, the subsequent repetition will assess the next metric in the list above, and so on and so forth.
Main outcomes and measures:
The two co-primary outcomes are:
- The improvement in surgical performance, as dictated by the composite score computed by the previously validated evaluation module of the ICEMS. Performance improvement is measured by the difference in composite score between each of the 6 repetitions of the practice scenario. Transfer of learning will be measured by the participant's composite score for the complex realistic scenario.
- The performance score of the participants in the complex realistic scenario, assessed by two blinded experts using the Objective Structured Assessment of Technical Skills (OSATS) global rating scale.
The secondary outcome is the differences in the strength of emotions elicited, measured before the practice scenario, immediately before the realistic scenario, and after completion of all attempts using the Duffy's Medical Emotional Scale (MES). Cognitive load will also be measured following completion of all tasks using Leppink's Cognitive Load Index (CLI). Both outcomes are measured using self-reports.
Statistical Analysis Plan: Participant data will be anonymized and stored. The ICEMS will assess the participant's surgical performance and provide a performance score at 0.2 second intervals throughout each repetition of the simulated surgical task. An average composite score will then be calculated for each repetition. Using ANCOVA, improvement in performance and participant learning will be assessed by comparing the composite score of the first practice scenario repetition (baseline) and the composite score of the sixth repetition (summative). Meanwhile, the composite score of the complex realistic scenario will be used to assess the transfer of learning using a one-way ANOVA. With an effect size of 0.25 and a significance of 0.05, a total sample size of 129 provides 80% power to detect a significant interaction.
Videos of participant performance in the complex realistic scenario will be evaluated by two blinded expert raters using the OSATS global rating scale. The OSATS score will be analyzed between groups using a one-way ANOVA to compare efficiency of learning and skill retention.
Emotional changes before, during, and after learning in the simulated scenarios will be evaluated using a two-way mixed ANOVA, while one-way ANOVA will be used to assess cognitive load after learning.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Control Group Intelligent Continuous Expertise Monitoring System (ICEMS) only verbal feedback group | No intervention | –43 participants. Individuals receive standard information. They perform 6 5-min practice scenario resections with a 5-min break between each one. The 7th attempt is the 13-min realistic scenario. Participants receive no feedback during the first repetition. They will then receive feedback on 4 metrics, one metric a time: instrument tip separation, low bipolar force, high aspirator force, high bipolar force. Once an attempt is completed without receiving feedback, the next repetition will assess the next metric in the list above. During the 5-min break after an attempt is completed without receiving feedback, participants can watch an optional expert-level demonstration video corresponding to the next metric. Participants receive no feedback during the 6th repetition. They will have no feedback in their 7th repetition, the realistic scenario. |
| Experimental Group ICEMS verbal feedback with pause group | Experimental | Behavioral: Experimental Group ICEMS verbal feedback with pause group43 participants. Individuals receive standard information. They perform 6 5-min practice scenario resections with a 5-min break between each one. The 7th attempt is the 13-min realistic scenario. Participants receive no feedback during the first repetition. They will then receive feedback on 4 metrics, one metric a time: instrument tip separation, low bipolar force, high aspirator force, high bipolar force. Once an attempt is completed without receiving feedback, the next repetition will assess the next metric in the list above. During the 5-min break after an attempt is completed without receiving feedback, participants can watch an optional expert-level demonstration video corresponding to the next metric. Participants receive no feedback during the 6th repetition. They will have no feedback in their 7th repetition, the realistic scenario. |
| Experimental Group ICEMS verbal feedback with pause and expert-level video demonstration | Experimental | Behavioral: Experimental Group ICEMS audio feedback with pause and expert video43 participants. Individuals receive standard information. They perform 6 5-min practice scenario resections with a 5-min break between each one. The 7th attempt is the 13-min realistic scenario. Participants receive no feedback during the first repetition. They will then receive feedback on 4 metrics, one metric a time: instrument tip separation, low bipolar force, high aspirator force, high bipolar force. Once an attempt is completed without receiving feedback, the next repetition will assess the next metric in the list above. During the 5-min break after an attempt is completed without receiving feedback, participants can watch an optional expert-level demonstration video corresponding to the next metric. Participants receive no feedback during the 6th repetition. They will have no feedback in their 7th repetition, the realistic scenario. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First and second year medical students who are actively enrolled in any Quebec institution who do not meet the exclusion criteria.
- Students actively enrolled in medical school in a preparatory year in any Quebec institution who do not meet the exclusion criteria.
Key exclusion criteria (1 listed)
- Participation in previous trials involving the NeuroVR (CAE Healthcare) simulator
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 |
|---|---|---|
| Experimental Group ICEMS verbal feedback with pause groupWhile performing the simulated procedure, if participants receive real-time verbal feedback based on the intelligent system error detection, they will be instructed to pause the task, putting their instruments down and reflecting for 22 seconds. A warning will be given when there are 7 seconds remaining in the reflection period so individuals can prepare to resume the task immediately. | Behavioural | Experimental Group ICEMS verbal feedback with pause group |
| Experimental Group ICEMS audio feedback with pause and expert videoWhile performing the simulated procedure, if participants receive real-time verbal feedback based on the intelligent system error detection, they will be instructed to pause the task, putting their instruments down, turning their attention to a 9-second expert-level demonstration video, and reflecting for 13 seconds. A warning will be given when there are 7 seconds remaining in the reflection period so individuals can prepare to resume the task immediately. | Behavioural | Experimental Group ICEMS verbal feedback with pause and expert-level video demonstration |
Primary outcome
Change in performance
Time frame: 1 day of study
Evaluated by comparing the average composite-score, calculated by the ICEMS, from each practice scenario. Scores range from expert/skilled level (a score of 1.00) to novice/less-skilled level (a score of -1.00).
Transfer of learning
Time frame: 1 day of study
Evaluated by comparing the average composite-score, calculated by the ICEMS, from each practice scenario. Scores range from expert/skilled level (a score of 1.00) to novice/less-skilled level (a score of -1.00).
Objective Structured Assessment of Technical Skills (OSATS) global rating scale
Time frame: 1 day of study
Performance score of the participants in the complex realistic scenario, assessed by two blinded experts using the Objective Structured Assessment of Technical Skills (OSATS) global rating scale on a 7-point Likert scale (1= novice to 7 = expert). Efficacy in learning with pausing methodology and an expert-level demonstration video will be compared to pausing methodology alone and to no pausing methodology.
2 secondary outcomes
Differences in strength of emotions elicited
Time frame: 1 day of study
Difference in Cognitive Load
Time frame: 1 day of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Background: PubMed 35473961Yilmaz 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.
- Background: PubMed 35191972Fazlollahi AM, Bakhaidar M, Alsayegh A, Yilmaz R, Winkler-Schwartz A, Mirchi N, Langleben I, Ledwos N, Sabbagh AJ, Bajunaid K, Harley JM, Del Maestro RF. Effect of Artificial Intelligence Tutoring vs Expert Instruction on Learning Simulated Surgical Skills Among Medical Students: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2149008. doi: 10.1001/jamanetworkopen.2021.49008.
- Background: PubMed 31373651Winkler-Schwartz A, Yilmaz R, Mirchi N, Bissonnette V, Ledwos N, Siyar S, Azarnoush H, Karlik B, Del Maestro R. Machine Learning Identification of Surgical and Operative Factors Associated With Surgical Expertise in Virtual Reality Simulation. JAMA Netw Open. 2019 Aug 2;2(8):e198363. doi: 10.1001/jamanetworkopen.2019.8363.
- Background: PubMed 33772840Lee JY, Szulewski A, Young JQ, Donkers J, Jarodzka H, van Merrienboer JJG. The medical pause: Importance, processes and training. Med Educ. 2021 Oct;55(10):1152-1160. doi: 10.1111/medu.14529. Epub 2021 May 1.
- Individual participant dataSharing planned: Yes. Data obtained from primary and secondary outcomes may be shared if other researchers have an interest in this data.
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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.
Rolando F Del Maestro, MD, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group ICEMS verbal feedback with pause group and Experimental Group ICEMS audio feedback with pause and expert video 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 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: status not confirmed, as of the sponsor's last update on 5 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rolando F Del Maestro, MD, PhD (519 708 0346, rolando.del_maestro@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in performance (time frame: 1 day of study). The study lists 3 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 NCT06235788, which also lists 4 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 5 Feb 2024.