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临床试验/NCT04498585
NCT04498585暂停不适用

Virtual Reality Stimulation to Relax and Reduce the Incidence of Delirium

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 920 人开始时间: 2021年4月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
920
试验地点
1
主要终点
Incidence of Delirium

研究概览

简要总结

Delirium has been long considered as a major contributor to cognitive impairments following a critical illness. Currently, both pharmacologic and non-pharmacologic prevention and treatment strategies are used in the intensive care unit, despite these strategies remaining controversial. However, with previous studies showing the feasibility of using virtual reality (VR) within the critical care setting, the investigators propose to use this technology to investigate the effect of 360-degree immersive virtual reality stimulation on the incidence of delirium in the ICU.

Stimulation will be provided for 30 minutes, three times a day, evenly spaced between 7:00 AM and 7:00 PM, using a commercially available head-mounted display. The investigators hypothesize that by providing relaxing virtual environments to patients through a head-mounted display and headphones, the incidence of delirium will be lower compared to the control group receiving no VR stimulation. Secondary outcomes will include evaluating the movement patterns and intensity between the intervention and control group, and between patients with and without delirium, using inertial measurement units and an under mattress bed sensor. It is hypothesized that it will be possible to detect difference in movement patterns between groups and identify patterns indicating the presence or absence of delirium. Secondary objective also include the evaluation of the effect of VR on duration of delirium. Here it is hypothesized that the duration of delirium will be shorter in participants receiving the VR stimulation compared to those in the control group. Physiological parameters (e.g. heart rate, respiration rate, oxygen saturation, etc.) will also be recorded during the stimulation to further understand what, if any, effect VR has.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • •Written Informed Consent (by the patient, relatives, or authorized representative)
  • •No severe visual or auditory impairments (strabismus, macular degeneration, retinopathy)
  • •Estimated length of stay >24 hours
  • •Can keep eyes open for at least 30 seconds
  • •German or French speaking

排除标准

  • •Known psychotic disorders associated with delusions (e.g. schizophrenia)
  • •Recent history of major depression
  • •Admission for drug overdose

研究组 & 干预措施

Intervention

Experimental

Participants who will be receiving standard ICU care and additionally the VR stimulation during their ICU stay.

干预措施: VR Stimulation (Other)

Control

No Intervention

Patients in the ICU who will be receiving standard ICU care during their ICU stay. Participants in this arm will not be receiving VR stimulation.

结局指标

主要结局

Incidence of Delirium

时间窗: Number of incidences during stay in the intensive care unit (to a maximum of 14 days)

Delirium will be assessed 3 times a day using the Intensive Care Delirium Screening Checklist. The screening will be conducted by trained critical care nurses. If a score greater than or equal to 4 is recorded, this will count as an incidence of delirium.

次要结局

  • Pattern of the movements before and during delirium(Recorded during entire stay in the ICU (to a maximum of 14 days))
  • Intensity of the movements before and during delirium(Recorded during entire stay in the ICU (to a maximum of 14 days))
  • Duration of Delirium(Recorded during entire stay in the ICU (to a maximum of 14 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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