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临床试验/NCT06797895
NCT06797895进行中(未招募)不适用

Designing a Virtual Reality Intervention to Improve Physical and Psychological Health in Intensive Care Units

Duke University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
1
主要终点
Feasibility as measured by nursing time required

研究概览

简要总结

The goal of this study is to explore if Virtual Reality helps patients in the cardiothoracic ICU move more and feel better. Participants will be asked to answer a survey about anxiety, depression, and loneliness. The study team will teach participants how to use the VR device and how to play the game. Participants will play the game at least once per day, but can play as much as they want. Study activities include nurse facilitated patient use of VR applications that involve upper body movement (e.g., using arms and hands to dance or hit objects in a virtual reality environment).

详细描述

Patients who survive critical illness and prolonged intensive care unit (ICU) stays are at risk for debilitating physical (deconditioning, skin injury, and infection), and mental health impairment (depression, anxiety and PTSD). Early mobility improves these deleterious outcomes but is challenging to implement in patients on prolonged bedrest. The purpose of this study is to compare a nurse-led implementation of a Virtual Reality (VR) experience in the Cardio-Thoracic Intensive Care Unit (CT-ICU) to standard of care to improve mobility for patients on prolonged bedrest. The investigators hypothesize that nurse-led implementation of VR experiences in the CT-ICU, in combination with engineering-led patient-centered customization of the VR applications, will improve both the physical and psychological function of ICU patients on prolonged bedrest.

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

  • •English speaking
  • •3+ days ICU admission with limited mobility

排除标准

  • •Pregnancy
  • •Blind/severe visual impairment
  • •History of seizures
  • •Intubation/sedation
  • •Special enteric contact isolation

研究组 & 干预措施

Virtual Reality (VR) intervention

Other

Cohort for observing the effects of the VR intervention on ICU mobility.

干预措施: VR assisted mobility (Behavioral)

结局指标

主要结局

Feasibility as measured by nursing time required

时间窗: up to 6 months

For each participant, the total nursing time spent (in minutes) setting up and delivering the intervention will be recorded.

次要结局

  • Usability as measured by patient-reported ease of playing the game(up to 6 months)
  • Change in Hospital Anxiety and Depression Scale (HADS) - depression(Baseline to day 10 or ICU transfer, whichever comes first)
  • Usability as measured by patient-reported ease of hand controller use(up to 6 months)
  • Usability as measured by patient-reported wearability of headset(up to 6 months)
  • Number of participants who find the intervention acceptable(up to 6 months)
  • Change in mobility activity frequency(Baseline, 6 months)
  • Usability as measured by patient-reported comfort of headset(up to 6 months)
  • Change in mobility activity time(Baseline, 6 months)
  • Change in Hospital Anxiety and Depression Scale (HADS) - anxiety(Baseline to day 10 or ICU transfer, whichever comes first)
  • Change in UCLA 3-item Loneliness Scale(Baseline to day 10 or ICU transfer, whichever comes first)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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