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临床试验/NCT04291196
NCT04291196已完成不适用

Virtual Reality as a Tool to Reduce Pre-procedure Anxiety Prior ECT Via Enhancing Patient Education

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2020年11月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Heart rate

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

Standard Treatment

Other

Patients will receive standard preparation for their ECT session.

干预措施: Standard Treatment (Other)

Immersive Virtual Reality

Experimental

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

干预措施: VR-ECT 360o Video (Other)

结局指标

主要结局

Heart rate

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

Heart rate will be measured in beats/min

Change in Pre-operative Anxiety

时间窗: 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

时间窗: 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.

Mean arterial blood pressure

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

Mean arterial blood pressure will be measured in mmHg.

次要结局

  • 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.)
  • Cognitive Performance(Measurement completed 1) Before intervention on the day of procedure 2) Prior to ECT on the day of procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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