Efficacy of Immersive Virtual Reality Rehabilitation on Patient Satisfaction and Experience, Functional and Clinical Outcomes, and Its Feasibility in Intensive Care Unit Treatment: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Patient satisfaction
研究概览
简要总结
Background: Virtual reality is recognized as a progressive technology with the potential to enhance the rehabilitation process. Immersive virtual reality-based treatments can improve motor outcomes in physical rehabilitation, reduce stress caused by the intensive care unit environment and maximize patients' recovery processes.
Objective: To analyze the efficacy of rehabilitation using immersive virtual reality on patient satisfaction and experience, functional and clinical outcomes and the feasibility of its application during the hospitalization period in an intensive care unit (ICU).
Methods: This is a randomized controlled clinical trial involving ICU patients aged 18 years or older, with an estimated ICU stay of ≥ 72 hours, the ability to understand and follow verbal instructions and no diagnosis of psychotic disorders, visual impairment, or hearing loss. Patients will be divided into two groups: one undergoing traditional physiotherapy rehabilitation - control group (CG), and the other receiving physiotherapy using immersive virtual reality (IVR group). The following evaluations will be conducted: mobility condition, physical and psychological discomfort, estimated physical activity level, occurrence of delirium, cognitive decline screening, functionality classification, motivation level, patient experience, sense of immersion in the virtual reality environment, patient satisfaction during the rehabilitation process, occurrence of adverse events, and protocol feasibility. Data will be presented in graphs and tables. Results will be considered statistically significant at a 5% significance level (p ≤ 0.05), and all analyses will be performed using SPSS Statistics version 22.
Expected results: The investigators expect to find evidence that rehabilitation using immersive virtual reality can promote and enable a more pleasant and less traumatic experience during the patient's hospitalization, with greater satisfaction and adherence to the proposed rehabilitation, in addition to being an effective tool to optimize patients' functional and clinical outcomes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years
- •Glasgow Coma Scale (GCS) score ≥14
- •Richmond Agitation-Sedation Scale (RASS) score between -1 and +1
- •Negative for delirium according to the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
- •Estimated ICU stay of ≥72 hours
- •Able to communicate in Portuguese
- •Understand and follow verbal instructions
- •Have no psychotic disorders, visual impairment or hearing loss.
排除标准
- •Hemodynamic instability
- •Signs of respiratory distress
- •Contact isolation for infectious diseases
- •Conditions that limit head and neck movement
研究组 & 干预措施
traditional physiotherapy rehabilitation
The traditional physiotherapeutic rehabilitation protocol will be guided by the characteristics of the early rehabilitation protocol in the ICU, structured by the rehabilitation service of Hospital Sírio-Libanês. This protocol provides recommendations for effective and applicable exercises based to the clinical reality, serving as a guiding resource in the care of critically ill patients.
干预措施: reabilitação fisioterapêutica tradicional (Procedure)
physiotherapy using immersive virtual reality
The immersive virtual reality physiotherapeutic rehabilitation protocol will employ 3D virtual reality headset that simulate human sensory input to create an immersive environment.
干预措施: fisioterapia utilizando realidade virtual imersiva (Procedure)
结局指标
主要结局
Patient satisfaction
时间窗: Day 1 and day 7 or intensive care unit discharge
To assess patient satisfaction, the investigators will use the Net Promoter Score (NPS) method, it is a methodology that indicates the likelihood of a consumer recommending products or services to others. The results are interpreted using the following parameters: 75-100% is considered "excellent," 50-74% is classified as "very good" and below 49% as "poor."
Patient experience: Perceived workload
时间窗: Day 1 and day 7 or intensive care unit discharge
To evaluate patient experience, the Raw Task Load Index (RTLX) will be used to assess perceived workload during or immediately after rehabilitation sessions. It is a multidimensional scale scored from 0 to 100, with higher scores indicating greater cognitive load.
Patient experience: Perceived motivation
时间窗: Day 1 and day 7 or intensive care unit discharge
Perceived motivation will be assessed using the Intrinsic Motivation Inventory (IMI), a 7-point Likert scale evaluating the individual's subjective experience during an activity (1 = strongly disagree; 7 = strongly agree).
Patient experience: Perceived presence
时间窗: Day 1 and day 7 or intensive care unit discharge
Patients in the immersive virtual reality group will also complete the Presence Questionnaire (PQ), a self-report tool that measures perceived presence in the VR environment across four domains: Engagement, Immersion/Adaptation, Sensory Fidelity, and Interface Quality. The PQ uses a 5-point Likert scale, with higher scores reflecting a stronger sense of presence.
次要结局
- Classification of physical activity level(Baseline)
- Muscle Strength(Baseline and after 7 days or intensive care unit discharge)
- Mobility Assessment(Baseline and after 7 days or intensive care unit discharge)
- Functionality Classification(Baseline and after 7 days or intensive care unit discharge)
- Delirium Assessment(Up to 7 days or intensive care unit discharge)
- Cognitive Function Assessment(Baseline and after 7 days or intensive care unit discharge)
- Assessment of Pain and Psychological Variables(Baseline and after 7 days or intensive care unit discharge)
- Rehabilitation Protocol Feasibility(After 7 days or intensive care unit discharge)
- Adverse Events: Fall risk(Up to 7 days or intensive care unit discharge)
- Adverse Events: Presence of symptoms(Up to 7 days or intensive care unit discharge)
研究者
Wellington Yamaguti
Principal Investigator
Hospital Sirio-Libanes