Effectiveness of Virtual Reality-based Relaxation on Electroconvulsive Therapy-related Anxiety
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in anxiety levels (BAI) from pre- to post-intervention comparing VR-based relaxation, breathing exercises, and treatment as usual (TAU).
研究概览
简要总结
The goal of this clinical trial is to learn if there is an effect of Virtual Reality (VR) based-relaxation on electroconvulsive therapy (ECT)-related anxiety. The main questions it aims to answer are:
- Does VR based-relaxation have an effect on anxiety in patients receiving ECT as part of routine clinical care?
- Does VR based-relaxation have an effect on stress symptoms and heart rate in patients receiving ECT as part of routine clinical care?
- Does depression severity have an effect on the effectivity of VR-based relaxation
Researchers will compare VR-relaxation to relaxation breathing exercises and no relaxation to see if VR-based relaxation has an effect on ECT-related anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Being treated with ECT, having had at least two sessions at study start
- •Able to understand study procedure and sign informed consent
- •Speaking Dutch or French
- •DSM-5 diagnosis of a depressive disorder, for which ECT treatment has been initiated
排除标准
- •- Contra-indications for VR: photosensitive epilepsy, severe travel sickness, vertigo, open wounds on the face
研究组 & 干预措施
Within-Subject Experimental Condition Group
Participants will undergo three experimental conditions (each twice and in random order): (1) VR-relaxation, (2) breathing exercises, and (3) treatment as usual (TAU, no additional intervention). Each participant serves as their own control.
干预措施: VR-based relaxation (Device)
Within-Subject Experimental Condition Group
Participants will undergo three experimental conditions (each twice and in random order): (1) VR-relaxation, (2) breathing exercises, and (3) treatment as usual (TAU, no additional intervention). Each participant serves as their own control.
干预措施: Breathing exercises (Other)
Within-Subject Experimental Condition Group
Participants will undergo three experimental conditions (each twice and in random order): (1) VR-relaxation, (2) breathing exercises, and (3) treatment as usual (TAU, no additional intervention). Each participant serves as their own control.
干预措施: Treatment as usual (Other)
结局指标
主要结局
Change in anxiety levels (BAI) from pre- to post-intervention comparing VR-based relaxation, breathing exercises, and treatment as usual (TAU).
时间窗: Pre-intervention to post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.
Measured through the Beck Anxiety Inventory (BAI), score 0-63, higher scores indicate more severe anxiety..
Change in anxiety levels (VAS-anxiety) from pre- to post-intervention comparing VR-based relaxation, breathing exercises, and treatment as usual (TAU).
时间窗: pre- to post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.
Measured through the Visual Analogue Scale for Anxiety (VAS-Anxiety), scale 0-10, higher scores indicate greater anxiety.
次要结局
- Improvement in stress symptom (VAS-Stress) score after VR relaxation in comparison to breathing exercises and TAU.(Pre-intervention and post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.)
- Improvement in stress symptom (heart rate) score after VR relaxation in comparison to breathing exercises and TAU.(Pre- and post-intervention. Post-intervention meaning within Minutes of ending relaxation intervention.)
- The effect of depression severity on the effectivity of VR-based relaxation.(Baseline)