Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT

Overview

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.

Full Title of Study: “Virtual Reality as a Tool to Reduce Pre-procedure Anxiety Prior ECT Via Enhancing Patient Education”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 30, 2023

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Immersive Virtual Reality
    • Patients will be immersed in the ECT experience using VR-ECT 360o video (VR-ECT).
  • Other: Standard Treatment
    • Patients will receive standard preparation for their ECT session.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Pre-operative Anxiety
    • Time Frame: 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 pre-operative anxiety will be assessed using the Visual Anxiety Scale (VAS, Not at all anxious to extremely anxious).
  • Change in ECT Knowledge
    • Time Frame: Measurement completed 1) Immediately Before ECT education 2) Immediately After ECT education 3) Immediately Prior to ECT
    • Change in ECT knowledge will be assessed using the ECT Attitude & Knowledge Questionnaire.
  • Heart rate
    • Time Frame: Measurement completed prior to ECT session on the day of procedure.
    • Heart rate will be measured in beats/min
  • Mean arterial blood pressure
    • Time Frame: Measurement completed prior to ECT session on the day of procedure.
    • Mean arterial blood pressure will be measured in mmHg.

Secondary Measures

  • Cognitive Performance
    • Time Frame: Measurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedure
    • Cognitive performance will be assessed using the Montreal Cognitive Assessment (MoCA).
  • Depression
    • Time Frame: Measurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedure
    • Depression will be assessed.
  • Ease of Use of VR Technology
    • Time Frame: Measurement completed immediately after ECT education on the day of procedure.
    • Ease of use of VR technology will be assessed using the system usability, scale (SUS), only in VR arm.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sunnybrook Health Sciences Centre
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Fahad Alam, MD, M.Sc., 416-480-4864, Fahad.Alam@Sunnybrook.ca

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