Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT

NCT04291196 | Active Not Recruiting

• 1 other identifier: 036-2019
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Change in Pre-operative Anxiety

  Change in pre-operative anxiety will be assessed using the Visual Anxiety Scale (VAS, Not at all anxious to extremely anxious).

  Measurement completed 1) up to 2-3 days before ECT education 2) right after ECT education 3) prior to ECT (day of proceudre)

• Change in ECT Knowledge

  Change in ECT knowledge will be assessed using the ECT Attitude \& Knowledge Questionnaire.

  Measurement completed 1) Immediately Before ECT education 2) Immediately After ECT education 3) Immediately Prior to ECT

• Heart rate

  Heart rate will be measured in beats/min

  Measurement completed prior to ECT session on the day of procedure.

• Mean arterial blood pressure

  Mean arterial blood pressure will be measured in mmHg.

  Measurement completed prior to ECT session on the day of procedure.

Secondary Outcomes (3)

• Cognitive Performance

  Measurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedure

• Depression

  Measurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedure

• Ease of Use of VR Technology

  Measurement completed immediately after ECT education on the day of procedure.

Study Arms (2)

Immersive Virtual Reality

EXPERIMENTAL

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

Other: VR-ECT 360o Video

Standard Treatment

OTHER

Patients will receive standard preparation for their ECT session.

Other: Standard Treatment

Interventions

VR-ECT 360o Video 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.

Immersive Virtual Reality

Standard Treatment OTHER

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

Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Fahad Alam

  SHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: March 2, 2020
• Study Start: November 27, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)