Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    64
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 28 January 2021

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.

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).

Details
Condition Benign Rolandic Epilepsy, education, Teaching, Endogenous depression, Depression, Electroconvulsive Therapy, Hemodynamics, mental health, Education, ANXIETY NEUROSIS, Anxiety, Cognition, Illiteracy, Depression (Major/Severe), Anxiety Disorders (Pediatric), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Depression (Treatment-Resistant), Generalized Anxiety Disorder (GAD), Depressed, Generalized Anxiety Disorder (GAD - Pediatric), Virtual Reality, Anxiety Symptoms, Anxiety Disorders, depressive disorder, bects, anxiety disorder, depressed mood, miserable, electroconvulsive therapy (ect), depressive disorders, anxious
Treatment Standard Treatment, VR-ECT 360o Video
Clinical Study IdentifierNCT04291196
SponsorSunnybrook Health Sciences Centre
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Benign Rolandic Epilepsy or Depression (Adolescent) or Depression (Treatment-Resistant) or Cognition or Electroconvulsive Therapy or Education or Anxi...?
Do you have any of these conditions: Endogenous depression or Depression (Major/Severe) or bects or Cognition or Teaching or Depression (Treatment-Resistant) or Hemodynamics or Depressed ...?
Do you have any of these conditions: Anxiety Disorders or Depression (Major/Severe) or ANXIETY NEUROSIS or bects or depressive disorder or Anxiety Symptoms or Cognition or Depression (Tre...?
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)
Clear my responses

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