The Evaluation of Virtual Reality Therapy Efficacy in the Treatment of Depressive and Anxiety Symptoms in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 4
- 主要终点
- Change in depressed mood and anxiety from baseline
研究概览
简要总结
This study evaluates the effectiveness of virtual reality (VR) therapy in the treatment of depression and anxiety symptoms in patients undergoing second stage of cardiac rehabilitation. Half of the study group will receive VR therapy (VR group) as an addition to cardiologically monitored physical training. The other half of the group (control group) will receive Schultz Autogenic Training as a standard supplement to cardiological training
详细描述
Cardiologically monitored physical training in second stage of cardiac rehabilitation leads to the improvement in the physical capacity and overall fitness of the patients with cardiovascular diseases, allowing restoration of independence in daily functioning. Psychological support is required in order to reduce the negative psychological symptoms related to the heart disease. In this study the investigators want to assess the effectiveness of the virtual reality (VR) therapy compared to standard psychological support (Schultz Autogenic Training).Thanks to using head mounted display (VR goggles) and the phenomenon of total immersion VR therapy allows to completely separate the patient from the hospital environment, provides an intense visual, auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming and mood-improving effect or, in another part of the therapy, it can motivate the patient to the rehabilitation process. The additional aim of the VR therapy is to help the patients regain their emotional balance, let them recognize their psychological resources and trigger the natural recovery mechanisms.
The aims of the project:
- The evaluation of the influence of VR therapy on the depressive symptoms and the anxiety level of the patients undergoing second stage of cardiac rehabilitation.
- The evaluation of the influence of VR therapy on the stress level of the patients undergoing second stage of cardiac rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary Artery Disease;
- •the second stage of cardiac rehabilitation conducted in outpatient settings;
排除标准
- •cognitive impairment (MMSE<24);
- •inability to self-complete the research questionnaires;
- •presence of the following issues at the time of the examination or in the medical data: disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders;
- •initiation of psychiatric treatment during the research project;
- •contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment);
- •the patient's refusal at any stage of the research project.
结局指标
主要结局
Change in depressed mood and anxiety from baseline
时间窗: At baseline and after 8 sessions of VR therapy (week 3)
The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms. HADS will be performed at the beginning and after four weeks of treatment.
次要结局
- Change in perception of stress from baseline(At baseline and after 8 sessions of VR therapy (week 3))
研究者
Joanna Szczepańska-Gieracha
Professor
Wroclaw University of Health and Sport Sciences