Virtual Reality to Reduce Delirium

Not Applicable

Suspended

• Conditions: Cognitive Impairment; Delirium
• Interventions: Other: VR Stimulation

• Registration Number: NCT04498585
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-04
• Study Start: 2021-04-14
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 920

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of Delirium	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.

Secondary Outcome Measures

Name	Time	Method
Pattern of the movements before and during delirium	Recorded during entire stay in the ICU (to a maximum of 14 days)	Movement patterns, measured as acceleration and rotation, will be measured using inertial measurement units. The data will be used to determine if there is a change in pattern or intensity between periods before and during delirium.
Intensity of the movements before and during delirium	Recorded during entire stay in the ICU (to a maximum of 14 days)	Movement patterns, measured as acceleration and rotation, will be measured using inertial measurement units. The data will be used to determine if there is a change in intensity between periods before and during delirium.
Duration of Delirium	Recorded during entire stay in the ICU (to a maximum of 14 days)	The duration of delirium will be evaluated per 8 hour periods, or as needed, while patients are in the ICU. If the participant is assessed as delirious during any of the assessments during an 8 hour span, the entire period will count as delirious.

Trial Locations

Locations (1)

Inselspital; 🇨🇭 Bern, Switzerland