The Evaluation of the Efficiency of Immersive Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Hospital Anxiety and Depression Scale (HADS)
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 the pulmonary rehabilitation. The first study group will receive VR therapy (VR group) as an addition to the traditional pulmonary rehabilitation. The second group (active control group) will receive Schultz Autogenic Training as a standard supplement to the pulmonary treatment. The third group (control group) will undergo only the traditional pulmonary rehabilitation.
详细描述
Pulmonary rehabilitation leads to the improvement to the physical capacity and overall fitness of the patients with COPD allowing restoration of independence in daily functioning.
Psychological support is required in order to reduce the negative psychological symptoms related to both the pulmonary disease itself and the comorbidities. 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 2018) 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 goals of the project:
- The evaluation of the influence of VR therapy on the depressive symptoms, the anxiety level and the stress level of the patients undergoing the pulmonary rehabilitation.
- The comparison of the influence of the VR therapy and Schultz Autogenic Training on the pulmonary rehabilitation process.
- The evaluation of the pulmonary therapy improvements in patients with and without depressive, anxiety or stress symptoms.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulmonary rehabilitation conducted in ward settings;
- •anxiety symptoms scored 8 and more in HADS-A or depressive symptoms scored 8 and more in HADS-D.
排除标准
- •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
Hospital Anxiety and Depression Scale (HADS)
时间窗: 15 minutes
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.
Perception of Stress Questionnaire (PSQ)
时间窗: 30 minutes
The Perception of Stress Questionnaire (PSQ) is a 27-item scale scoring from 1 to 5 for each item. 21 items examine the level of stress in the area of emotional tension, external stress and intrapsychic stress, and 6 items refer to the lie scale. The global scoring for perception of stress ranges from 21 to 105 with a cut-off point of 60 for high level of perceived stress. The higher the score, the greater the sense of stress. PSQ will be performed at the beginning and after four weeks of treatment.
次要结局
- Spirometry Test(20 minutes)
- Six-Minute Walk Test (6MWT)(10 minutes)
研究者
Joanna Szczepańska-Gieracha
Professor
Wroclaw University of Health and Sport Sciences