Digital Rehabilitation Environment Augmenting Medical System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessment of anxiety measured by Hospital Anxiety and Depression Scale (HADS) questionnaire
研究概览
简要总结
D.R.E.A.M.S. will assess an immersive digital reality-augmenting system in reducing the occurrence of cognitive, behavioral, and emotional consequences of critical illness and environmental exposures that are risk factors for the development of delirium.
详细描述
The purpose of Digital Rehabilitation Environment Augmenting Medical System (D.R.E.A.M.S.) is to research the feasibility and clinical potential of an immersive digital reality-augmenting system in reducing the occurrence of cognitive, behavioral, and emotional consequences of critical illness (e.g. pain, anxiety and insomnia) and environmental exposures (noise & light) that are risk factors for the development of delirium, a common and devastating complication in the intensive care unit (ICU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •All patients ≥ 18 years admitted to University of Florida (UF) Health Shands Hospital who do not have a positive Confusion Assessment Method (CAM) score, including ICU patients.
排除标准
- •The study team will exclude patients if:
- •Their anticipated ICU stay is less than one day
- •Patient is intubated and cannot communicate.
- •Age: < 18 years
- •Patient with recent (within 6 months) neuro-vascular event, intra-cranial surgery, and/or acute neurological condition as primary ICU admission reason
- •Baseline cognitive impairment (e.g., advanced dementia)
- •Patients who are unable to wear or use the DREAMS equipment
研究组 & 干预措施
Mediation and Relaxation Intervention
Patients will undergo a technology based guided meditation and relaxation exercise through use of an application on a tablet or virtual reality headset.
干预措施: Technology based guided meditation and relaxation (Device)
结局指标
主要结局
Assessment of anxiety measured by Hospital Anxiety and Depression Scale (HADS) questionnaire
时间窗: Immediately before and after each intervention Up to 7 days
The assessment is used to gauge the subject's level of anxiety and depression 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Heart Rate
时间窗: Immediately before and after each intervention up to 7 days
Alterations to vital signs allow for Non-Verbal Pain assessments
Blood Pressure -Systolic
时间窗: Immediately before and after each intervention up to 7 days
Alterations to vital signs allow for Non-Verbal Pain assessments
次要结局
- Patient pain perception(Immediately before and after each intervention up to 7 days)
- Respiratory Rate(Entire ICU stay up to 7 days)
- Amount of sedatives requested by subjects(Entire ICU stay up to 7 days)
- Subject's quality of sleep(Daily up to 14 days)
- Amount of sedatives subjects receive(Entire ICU stay up to 7 days)
- DREAMS usability and acceptability questionnaire(After each intervention up to 14 days)