Virtual Reality to Reduce Delirium

Insel Gruppe AG, University Hospital Bern

Status: Suspended

Conditions: Delirium; Cognitive Impairment

Treatments: Other: VR Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04498585

2020-00039 (Other Identifier)

KEK2020-00039

Details and patient eligibility

About

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.

Enrollment: 920 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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920 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Other: VR Stimulation

Control

No Intervention group

Description:

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.