Virtual Reality for Anxiety Management in Mechanically Vented Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Incidence of safety events
研究概览
简要总结
The purpose of this study is to investigate the safety and feasibility of virtual reality for anxiety treatment in mechanically ventilated patients.
详细描述
Mechanically ventilated patients (those on a breathing machine) often experience heightened levels of anxiety and discomfort. This is usually treated by using sedative medications, however these drugs often have unintended side effects. This study will investigate the safety and feasibility of using relaxing virtual reality environments for reduction of anxiety in mechanically ventilated patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Age: 18 years or older
- •Mechanically ventilated; defined as having an endotracheal tube or tracheostomy and requiring continuous support from a mechanical ventilator.
- •Able to spontaneously maintain a state of wakefulness and alertness and able to follow commands
- •Able to communicate with research staff; defined as writing or head nods/shakes
排除标准
- •Delirious; defined as positive on the Confusion Assessment Method for the ICU (CAM-ICU +)
- •Expected to be liberated from ventilator within 12 hours of potential enrollment
- •Existence of skull injury or recent surgery (craniectomy) which precludes safely wearing VR visor
- •Impaired ability to see or hear, as determined by study investigator
- •Ventilator settings with positive end expiratory pressure (PEEP) greater than 10
- •Inability to be safely removed from physical restraints for VR (virtual reality) sessions
- •Chronic ventilator dependence prior to the present hospitalization
- •Lacking capacity to consent for one's self
- •Known difficult airway; based on review of intubation note
- •Tracheostomy performed within last seven days
- •Pre-existing symptoms overlapping with major symptoms of cyber-sickness: Headache, Vertigo (dizziness), Ataxia (tremor with movement), Nausea, Vomiting.
结局指标
主要结局
Incidence of safety events
时间窗: Immediately following treatment session
Occurrence rate of safety events, defined as cardiac arrhythmias, hypotension, hypertension, oxygen desaturation, falls to the floor, or unintentional removal of a medical tube or device.
次要结局
- Change in anxiety level during virtual reality treatment(Immediately following treatment session)