Comparing Virtual Reality Simulation to High Fidelity Simulation as an Educational Modality for Electroconvulsive Therapy Training: A Non-Inferiority Study (ECT-SIM)

Sunnybrook Health Sciences Centre

Status: Not yet enrolling

Conditions: Education, Medical, Undergraduate; Electroconvulsive Therapy; Virtual Reality Simulation

Treatments: Other: Virtual Reality electroconvulsive therapy simulator; Other: Mannequin Simulator

Study type: Interventional

Funder types: Other

Identifiers

NCT07350278

6838

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

VR Simulator Group

Experimental group

Description:

Participants randomized to this group will practice electroconvulsive therapy (ECT) administration using a virtual reality (VR) ECT simulator.

Treatment:

Other: Virtual Reality electroconvulsive therapy simulator

Mannequin Simulator Group

Active Comparator group

Description:

Participants randomized to this group will practice electroconvulsive therapy (ECT) administration using a mannequin ECT simulator.

Treatment:

Other: Mannequin Simulator