Depression Clinical Trial
— PERFECT-VROfficial title:
Virtual Reality as a Tool to Reduce Pre-procedure Anxiety Prior ECT Via Enhancing Patient Education
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.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | |
Primary | Heart rate | Heart rate will be measured in beats/min | Measurement completed prior to ECT session on the day of procedure. | |
Primary | 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 | Cognitive Performance | Cognitive performance will be assessed using the Montreal Cognitive Assessment (MoCA). | Measurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedure | |
Secondary | Depression | Depression will be assessed. | Measurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedure | |
Secondary | Ease of Use of VR Technology | Ease of use of VR technology will be assessed using the system usability, scale (SUS), only in VR arm. | Measurement completed immediately after ECT education on the day of procedure. |
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