Clinical trial NCT04291196: Virtual Reality to Reduce Pre-procedure Anxiety Prior ECT
Official title: Virtual Reality as a Tool to Reduce Pre-procedure Anxiety Prior ECT Via Enhancing Patient Education
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ECT
Electroconvulsive Therapy
Virtual Reality
Anxiety
Education
Hemodynamics
Depression
Cognition
Mental Health
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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)

Primary outcomes:
measure: Change in Pre-operative Anxiety
timeFrame: Measurement completed 1) up to 2-3 days before ECT education 2) right after ECT education 3) prior to ECT (day of proceudre)
measure: Change in ECT Knowledge
timeFrame: Measurement completed 1) Immediately Before ECT education 2) Immediately After ECT education 3) Immediately Prior to ECT
measure: Heart rate
timeFrame: Measurement completed prior to ECT session on the day of procedure.
measure: Mean arterial blood pressure
timeFrame: Measurement completed prior to ECT session on the day of procedure.
Secondary outcomes:
measure: Cognitive Performance
timeFrame: Measurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedure
measure: Depression
timeFrame: Measurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedure
measure: Ease of Use of VR Technology
timeFrame: Measurement completed immediately after ECT education on the day of procedure.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: SHSC
name: Fahad Alam
role: PRINCIPAL_INVESTIGATOR
References: