Psychometric and Physiological Assessment of the Effects of Vir-tual Reality in Cardiovascular Rehabilitation: a Randomized Con-trolled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Emotional benefit and distress reduction
研究概览
简要总结
Virtual reality (VR) is a high-end user-computer interface involving real-time stimulation and interaction of an embedded subject through visual and auditory sensorial channels, based on a synthetic environment in which the subject feels to be present. Over the past few decades, VR has been extensively used in psychological and neuroscientific research, as well as clinical applications, yielding promising results for diverse clinical conditions. Furthermore, VR has also been employed in the cardiovascular field across various settings, including cardiac rehabilitation, interventional cardiology, and cardiac surgery, to assess both physiological and psychological outcomes.
The benefits of using VR may stem from its ability to be customized, potentially enhancing the rehabilitation experience by offering cognitive, emotional, and physical advantages. It can improve patients' motivation and engagement, reduce anxiety. In general, in the context of cardiac rehabilitation, the impact of VR appears to be more closely linked to improvements in mental health, particularly in relation to psychological aspects such as mood enhancement, stress reduction, and increased emotional well-being. These benefits may be due to the immersive and engaging nature of VR, which can provide a sense of novelty, distraction from discomfort, and a greater feeling of control over the rehabilitation process. However, current evidence does not clearly demonstrate its superiority over conventional approaches in other important outcomes, including treatment adherence, patient satisfaction, and overall quality of life. The aim of this study was to test the efficacy of integrating the use of a VR system based on driving simulation in cardiac rehabilitation through a randomized controlled trial.
详细描述
The study is an RCT. The control group of this study performed a conventional cardiac rehabilitation protocol that consisted of a 1.5-hour group calisthenics sessions with a 10-minute break, held six times per week.
Patients were randomly allocated to the experimental virtual reality group and underwent the standard cardiac rehabilitation program, but some sessions were substituted by the virtual reality rehabilitation protocol. The VR intervention consisted of a simulated driving experience delivered over nine sessions, three times per week, each lasting 20 minutes, over a three-week period. Participants observed the virtual scenario through Meta Quest 2 head-mounted display. The 3D environment consisted of a realistic 3D model of a car's interior, simulating the driver's perspective (1:1 scale). The virtual cockpit incorporated an interactive steering wheel, controlled by participants from their perspective using Meta Controllers. This interaction, however, did not alter the vehicle's movement path. To optimize immersion, the Meta Controllers were rendered as hands, integrated with a 3D avatar model. The various scenarios the patient encountered corresponded to a progressively increasing level of difficulty as the rehabiltative sessions proceeded. Examples of challenging elements included narrow roads, urban traffic, tunnel driving, and high-speed roads. Each session lasted approximately 20 minutes, which was the time required to complete the driving route. However, the session might end earlier if the patient was unable to continue.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Masking Description
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
- •Diagnosis of cardiovascular disease and need for intensive inpatient cardiac rehabilitation after cardiac surgery;
- •Age over 18 years;
- •Absence of comorbidities (cognitive deficits, psychiatric syndromes, visual sensitivity; physical conditions);
- •Ability to understand and follow instructions provided by physiotherapists.
排除标准
- 未提供
结局指标
主要结局
Emotional benefit and distress reduction
时间窗: This scale was administered at three time points: as baseline, before the beginning of intervention (Day 0), after the first session of treatment (Day 1) and after intervention completion (Day 21)
Hospital Anxiety and Depression Scale (HADS): A 14-item scale used to assess anxiety (7 items) and depression (7 items) levels related to illness. This scale is widely used to assess general mental health in hospitalized patients and chronically ill patients, allowing for symptom monitoring rather than making a specific diagnosis.
次要结局
- Upper limb Range of Motion(This evaluation was made at two time points: after the first session of treatment (Day 1) and after intervention completion (Day 21))