Comparing Virtual Reality Simulation to High Fidelity Simulation as an Educational Modality for Electroconvulsive Therapy Training: A Non-Inferiority Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality electroconvulsive therapy simulator, Mannequin Simulator.
- Who it may be relevant to
- Registry conditions: Education, Medical, Undergraduate, Electroconvulsive Therapy, Virtual Reality Simulation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this prospective, open-label non-inferiority randomized controlled trial is to investigate if Virtual Reality (VR) based simulation are an effective training tool for novice medical trainees. The main questions it aims to answer are: * Is the VR-based electroconvulsive therapy (ECT) training program non-inferior to traditional, mannequin-based ECT training programs in fostering ECT skill acquisition? * What are the changes in confidence in administering ECT, as well as number of training repetitions completed in the VR and mannequin training groups? * What is the ease of use of the VR-based ECT training program? Researchers will compare the VR-based ECT training program to a mannequin-based ECT training program to see if the VR-based ECT training program is comparable to traditional methods at training for ECT. Participants will: * Complete an ECT skills assessment at the beginning and end of the study session. * Watch a 30-minute didactic ECT lecture video. * Be randomized to either the VR ECT simulation group or the mannequin ECT simulation group and be given 30 minutes to practice ECT administration with their assigned education tool.
Detailed description
Electroconvulsive therapy (ECT) is one of the most validated treatments for major depressive disorder (MDD), particularly treatment-resistant MDD where patients do not respond to at least two full courses of antidepressant medications and one full course of cognitive behavioral therapy. Despite its proven efficacy and safety, ECT is still heavily underutilized compared to other treatments. One of the causes for ECT underutilization is a stagnation in the growth in numbers of ECT-competent practitioners over the past 30 years. This issue stems from a lack of formal, standardized, and effective ECT training for medical trainees.
Virtual reality (VR) technology has been emerging as a promising medium for medical training due to its ability to create highly immersive and interactive simulations. Compared to traditional simulation mediums such as high-fidelity mannequins, VR is advantageous in that the cost of repeated use is low, usage of VR is not limited to a specialized facility, and VR training programs can be easily disseminated. VR-based simulations for medical training has already been developed for disciplines such as anesthesiology, where VR-based simulation tools are used to aid the learning of techniques such as bronchoscopy. However, there currently lacks a validated VR training tool for ECT.
Here the investigators propose to study a VR-based ECT training simulation, and see if it is non-inferior to a mannequin-based ECT training simulation. The mannequin-based simulation represents experiential learning, which is one of the ways ECT is currently taught.
Medical students who have not received any ECT training (N = 78) will begin the study by completing an ECT skills assessment test, where they must go through an ECT scenario on a mannequin. Afterwards, participants will watch a 30-minute didactic ECT lecture video. Participants will then be randomized to either the intervention group (VR simulation training group, N = 39) or the active control (mannequin simulation training group, N = 39). Participants will be instructed on how to use their assigned education modality, then given around 30 minutes to practice with their education modality. After the training sessions, participants will complete the ECT skills assessment test again.
The ECT skills assessment tests will be recorded, and two blinded raters will rate the ECT competency of the participant based on an ECT competency scale. Participants will also be asked how confident they are at administering ECT before and after the training sessions, as well as how many training repetitions they completed during their session.
Interventions
- Other Virtual Reality electroconvulsive therapy simulator
A virtual reality (VR)-based simulator for electroconvulsive therapy (ECT) practice. Users will go through tutorials on how to use the VR equipment and be guided through an ECT tutorial, then they can practice ECT with no guidance at 3 distinct difficulty levels. Level 1 of the simulator will contain ECT scenarios with very few patient conditions that need additional consideration. Level 2 will contain more patient conditions that need additional consideration, as well as a chance for adverse ev - Other Mannequin Simulator
A mannequin that users can use to practice electroconvulsive therapy (ECT) administration on. Users will be provided a mannequin and ECT equipment, as well as a scenario check-list to go through.
Primary outcome measures
- Electroconvulsive Therapy Objective Structured Assessment of Technical Skills (ECT-OSATS) [Time frame: Before and after the study educational intervention administration (day 1)]
Secondary outcome measures (2)
- VR System Usability Scale (SUS) [Time frame: After the study educational intervention administration (day 1)]
- Rate of Learning Questionnaire [Time frame: Before and after the study educational intervention administration (day 1)]
Eligibility criteria
Inclusion criteria
- Is a medical student at the University of Toronto
- Has not received formal ECT training before
Exclusion criteria
- Visual or hearing impairment that does not allow the participant to use VR.
- History of significant motion sickness.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Canada · 1 center
- Sunnybrook Health Sciences Centre — Toronto
Identifiers
NCT: NCT07350278 · 6838