Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT

NCT ID: NCT04291196

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-27
• Study Completion Date: 2025-12-31

Brief Summary

Lack of patient knowledge about ECT (electroconvulsive therapy) is a leading cause of treatment fear with 60% of ECT patients reporting high levels of anxiety.

The purpose of this study is to determine if using Virtual Reality (VR) to allow patients' to experience a virtual ECT education session before treatment is useful in lowering treatment anxiety and increasing knowledge about ECT if compared to standard treatment. In addition, measuring heart rate and blood pressure levels before ECT treatment will allow us to assess changes in anxiety levels.

Individuals who choose to participate will be placed (participant will have a 50% chance to be placed in either group) to view either a virtual reality video to experience a virtual ECT session, or to receive standard preparation, i.e. a discussion with a psychiatrist. Before and after this session participants will be asked to complete a measurement of their anxiety level and knowledge about ECT (ECT Attitude & Knowledge Questionnaire). Just before ECT treatment, blood pressure, heart rate and anxiety level will be measured. Participants will also complete cognitive and depression assessments.

This study will help to develop a relationship between healthcare providers and patients and their families to help with education before ECT treatment.

Detailed Description

Virtual reality (VR) is increasingly being used in healthcare, in particular as a form of exposure therapy for patients with psychiatric disorders. It immerses patients into hospital-based procedures. We and others showed that VR prep reduces anxiety levels for elective surgical patients (manuscript submitted). However, the efficacy of VR in reducing peri-procedural anxiety in vulnerable psychiatric populations has not been assessed. This will be the first RCT utilizing VR to reduce patient anxiety before ECT through education. If VR education reduces anxiety in this vulnerable population (as proof of concept), it could increase ECT success by decreasing anesthetic requirements. Using VR technology, our study will provide patients and their families with a balanced and in-depth look at ECT safety and efficacy, and its recent advances in management of psychiatric disorders.

Primary objectives of this study are to assess whether creating a VR-ECT-360 video that immerses and educates patients and their families in the ECT experience 1) enhances factual knowledge and reduces stigmatizing attitudes toward ECT, and 2) reduces pre-procedure anxiety as compared to traditional 2D video. The secondary objective is to investigate the ease of use of VR technology in a vulnerable psychiatric patient population. Given the high rate of treatment refusals in this population, we hypothesize that implementation of our approach will reduce anxiety through patient education thereby decreasing chances for treatment refusal and drop-out rates. We suggest that use of VR will be a clinically relevant approach in such a vulnerable population (as proof of concept) and could increase ECT success by decreasing anesthetic requirements (anesthetics suppress desired seizure activity).

Conditions

ECT; Electroconvulsive Therapy; Virtual Reality; Anxiety; Education; Hemodynamics; Depression; Cognition; Mental Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Immersive Virtual Reality

Patients will be immersed in the ECT experience using VR-ECT 360o video (VR-ECT).

Group Type: EXPERIMENTAL

VR-ECT 360o Video

Intervention Type: OTHER

Patients in the VR arm will be immersed in the ECT process in first person utilizing Google Cardboard headsets. Patients will experience in 360 entering the procedure room, IV insertion, pretreatment checks, anesthetic induction followed by induction of seizure, and recovery. The experience will also have voice-over narration simultaneously describing the procedure and its risks and benefits.

Standard Treatment

Patients will receive standard preparation for their ECT session.

Group Type: OTHER

Standard Treatment

Intervention Type: OTHER

Patients will receive preparation for their ECT as per standard of care, i.e. a discussion with a Psychiatrist.

Interventions

VR-ECT 360o Video

Patients in the VR arm will be immersed in the ECT process in first person utilizing Google Cardboard headsets. Patients will experience in 360 entering the procedure room, IV insertion, pretreatment checks, anesthetic induction followed by induction of seizure, and recovery. The experience will also have voice-over narration simultaneously describing the procedure and its risks and benefits.

Intervention Type: OTHER

Standard Treatment

Patients will receive preparation for their ECT as per standard of care, i.e. a discussion with a Psychiatrist.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥18
• First time undergoing ECT within the last year
• Outpatient/inpatient recommended for ECT
• Within 2-4 days of ECT procedure or no ECT within the past year
• Referred by psychiatrist
• Able to understand English
• Able to watch and respond to questions

Exclusion Criteria

• Lack of patient consent or capacity to give consent
• Visual and hearing impairments precluding the ability to watch or listen to video
• History of significant motion sickness (i.e. occur during exposure to physical, visual and virtual motion, cybersickness verbally declared by patient)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fahad Alam

Role: PRINCIPAL_INVESTIGATOR

SHSC

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

036-2019

Identifier Type: -

Identifier Source: org_study_id