Clinical trial NCT04498585: Virtual Reality to Reduce Delirium
Official title: Virtual Reality Stimulation to Relax and Reduce the Incidence of Delirium
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Delirium
Cognitive Impairment
Keywords: Virtual Reality
Delirium
Intensive Care Unit
Critical Care
Movement Analysis
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2020-08-04
Enrollment: 920
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of Delirium
timeFrame: Number of incidences during stay in the intensive care unit (to a maximum of 14 days)
Secondary outcomes:
measure: Pattern of the movements before and during delirium
timeFrame: Recorded during entire stay in the ICU (to a maximum of 14 days)
measure: Intensity of the movements before and during delirium
timeFrame: Recorded during entire stay in the ICU (to a maximum of 14 days)
measure: Duration of Delirium
timeFrame: Recorded during entire stay in the ICU (to a maximum of 14 days)
Other outcomes:
measure: Cognitive Functioning
timeFrame: Compared between functioning at discharge to 6-months post-discharge.
measure: Health Related Quality of Life
timeFrame: Compared between quality pre-admission to 6-months post-discharge.
measure: Functional Independence
timeFrame: Compared between quality pre-admission to 6-months post-discharge.
measure: Heart Rate
timeFrame: Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).
measure: Blood Pressure
timeFrame: Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).
measure: Respiration Rate
timeFrame: Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).
measure: Oxygen Saturation
timeFrame: Every stimulation period for the duration of the patient's time in the ICU (to a maximum of 14 days).
measure: System Usability Scale
timeFrame: Once a day for the duration of the patient's time in the ICU (to a maximum of 14 days).
Locations:
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: Department of Intensive Care Medicine, University Hospital Bern (Inelspital)
name: Matthias Hänggi, Dr. med
role: PRINCIPAL_INVESTIGATOR
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