跳至主要内容
临床试验/NCT05380700
NCT05380700已完成不适用

Virtual Reality Stimulation on the Intermediate Care Unit

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Acceptability of providing virtual reality stimulation

研究概览

简要总结

The goal of this substudy (main study NCT04498585) is to determine the feasibility of applying virtual reality stimulation to patients in the intermediate care unit. Patients on this ward are generally more awake and alert than patients in the intensive care unit, thereby they are able to provide feedback about their experience. As the intermediate care unit is not without stress, examining the physiological parameters (e.g., heart rate, respiration rate, blood pressure, etc.) could also provide telling information as to the calming effect of virtual reality. The movements of these patients are also recorded using accelerometers which will provide valuable information about the characteristics of the movements that patients make while confined to their beds. These movements can act as a reference for further investigation into movements related to delirium which is a secondary outcome measure of the main study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • Written informed consent
  • Aged ≥18 years
  • No severe visual or auditory impairments (strabismus, macular degeneration, retinopathy)
  • German or French speaking
  • Estimated length of stay (from time of study inclusion) >24 hours

排除标准

  • Patients without calotte, with external ventricular drainage or other Intracranial pressure probes
  • Patients with epilepsy
  • Patients with Covid-19

结局指标

主要结局

Acceptability of providing virtual reality stimulation

时间窗: Recorded immediately after every VR stimulation

To determine the acceptability of providing VR stimulation to patients in the intermediate care (IMC) unit based on 1) the subjective perception of the feedback, and 2) the ability of the stimulation to be maintained for minimum 20 minutes.

Safety of providing virtual reality stimulation

时间窗: Safety will be determined based on the reporting of adverse or serious adverse events in the 1-hour following the completion of the VR stimulation.

To determine the safety based on the adverse or serious adverse events reported by the medical staff, or the subjective reporting of the participant who received the VR stimulation.

次要结局

  • Heart Rate(Recorded during entire stay in the IMC (up to 24 hours))
  • Oxygen Saturation(Recorded during entire stay in the IMC (up to 24 hours))
  • Blood Pressure(Recorded during entire stay in the IMC (up to 24 hours))
  • Respiration Rate(Recorded during entire stay in the IMC (up to 24 hours))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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