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

NCT07350278 | Not Yet Recruiting

• 1 other identifier: 6838
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

virtual reality; mannequin; education; electroconvulsive therapy

Outcome Measures

Primary Outcomes (1)

• Electroconvulsive Therapy Objective Structured Assessment of Technical Skills (ECT-OSATS)

  A comprehensive ECT proficiency assessment tool including a technical skills checklist and a global performance rating scale. The technical skills checklist includes specific tasks during ECT administration that need to be completed to ensure a successful ECT delivery. Scores for each task can range from 1 - "Not Done" to 3 - "Done Correctly". Higher scores indicate better performance. The global performance rating scale includes items such as "Efficiency", "Knowledge", "Communication", and "Overall Impression of Performance" of the participant's ECT administration session as a whole. Scores can range from 1 - 5, with higher scores indicating a more positive outcome. The rating scale culminates with a "Global Impression of Pass or Fail", with options of "Fail" - the participant cannot perform ECT independently, or "Pass" - the participant can perform ECT independently. The ECT-OSATS was adapted from Rabheru et al. (2013).

  Before and after the study educational intervention administration (day 1)

Secondary Outcomes (2)

• VR System Usability Scale (SUS)

  After the study educational intervention administration (day 1)

• Rate of Learning Questionnaire

  Before and after the study educational intervention administration (day 1)

Study Arms (2)

VR Simulator Group

EXPERIMENTAL

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

Other: Virtual Reality electroconvulsive therapy simulator

Mannequin Simulator Group

ACTIVE COMPARATOR

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

Other: Mannequin Simulator

Interventions

Virtual Reality electroconvulsive therapy simulator OTHER

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 events to occur during treatment. Level 3 will contain many patient conditions that require the user to consider when deciding how to provide ECT, as well as a high chance of adverse events occurring. Users will be shown how well they did after completing a run of a scenario.

VR Simulator Group

Mannequin Simulator OTHER

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.

Mannequin Simulator Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a medical student at the University of Toronto
• Has not received formal ECT training before

You may not qualify if:

• Visual or hearing impairment that does not allow the participant to use VR.
• History of significant motion sickness.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Study Officials

• Fahad Dr. Alam, MD, FRCPC, MHSc

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

• Peter Giacobbe, MD, MSc, FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fahad Alam, MD, FRCPC, MHSc

CONTACT

416-480-4864; Fahad.Alam@Sunnybrook.ca

Lilia Kaustov, PhD

CONTACT

416-480-6100; lilia.kaustov@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomized controlled non-inferiority study

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 20, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: No interim analysis plan is in place, so data will be available following publication of the primary results after trial completion.
• Access Criteria: Data and supporting information will be made available following reasonable request directly to study PI.

Locations

CA (1)