Virtual Reality-Based Cognitive Stimulation Games for Enhancing Attention and Preventing Delirium in Older Surgical Patients With Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
研究概览
简要总结
This trial aims to evaluate the feasibility, safety, and acceptability of a virtual reality (VR)-based cognitive stimulation game to reduce postoperative delirium among older surgical patients at high risk due to pre-existing cognitive impairment.
详细描述
Delirium is a sudden, fluctuating disturbance in consciousness and cognition and is highly prevalent in older surgical patients. Delirium is preventable; non-pharmacological interventions, such as cognitive stimulation (CS), are the best preventive strategies. Implementing CS in acute hospital settings is a significant challenge due to limited resources and low patient engagement. Virtual reality (VR) and gamification for CS delivery could be a scalable, engaging solution. Based on my preliminary work, I hypothesize that VR- based CS games will be safe, feasible, and acceptable in high-risk older patients (Aim 1). The proposed study will estimate the intervention's effect on cognitive functions, particularly sustained attention (Aim 2), and the incidence of postoperative delirium (Aim 3). To accomplish the above goals, I will conduct a randomized controlled pilot trial involving 90 patients ≥65 years old with pre-existing cognitive impairment admitted to the hospital following a major surgery. Patients will be randomized 1:1:1 to receive VR-based CS games (intervention), watch a VR movie (VR control), or receive standard-of-care nurse-led reality orientation (Nurse control). The trial will provide me with preliminary data to support an R01 application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥65 years of age
- •Have a pre-existing diagnosis of cognitive impairment (Montreal Cognitive Assessment Score of 15-24)
- •Elective or emergency major surgery with the expectation of admission to the Intensive Care Unit following the surgery for three days following surgery
排除标准
- •Pre-existing Intubation and invasive ventilation;
- •history of severe mental illness;
- •admission for a drug overdose;
- •severe vertigo;
- •history of severe postoperative nausea and vomiting;
- •hearing and visual impairment;
- •preexisting severe dementia (Montreal Cognitive Assessment Score < 15; and
- •active delirium at the time of screening for eligibility criteria.
- •Active suicidal ideation or behavior Screen failure after surgery
- •Prolonged intubation after surgery (more than 24 hours)
研究者
Hina Faisal
Associate Professor of Surgery, Anesthesia & Critical Care
The Methodist Hospital Research Institute