Virtual reality stimulation to reduce the incidence of delirium in critically ill patients: study protocol for a randomized clinical trial

Aileen C Naef, Marie-Madlen Jeitziner, Stephan M Gerber, Béatrice Jenni-Moser, René M Müri, Stephan M Jakob, Tobias Nef, Matthias Hänggi, Aileen C Naef, Marie-Madlen Jeitziner, Stephan M Gerber, Béatrice Jenni-Moser, René M Müri, Stephan M Jakob, Tobias Nef, Matthias Hänggi

Abstract

Background: Delirium has been long considered as a major contributor to cognitive impairments and increased mortality following a critical illness. Pharmacologic and non-pharmacologic strategies are used against delirium in the intensive care unit (ICU), despite these strategies remaining controversial. Previous studies have shown the feasibility of using virtual reality within the ICU setting, and we propose to use this technology to investigate the effect of immersive virtual reality stimulation on the incidence of delirium in the ICU. Moreover, we propose to use motion sensors to determine if patient movement patterns can lead to early prediction of delirium onset.

Methods: This study is conducted as a randomized clinical trial. A total of 920 critically ill patients in the ICU will participate. The control group will receive standard ICU care, whereas the intervention group will, in addition to the standard ICU care, receive relaxing 360-degree immersive virtual reality content played inside a head-mounted display with noise-cancelling headphones, three times a day. The first 100 patients, regardless of their group, will additionally have their movement patterns recorded using wearable and ambient sensors. Follow-up measurements will take place 6 months after discharge from the ICU.

Discussion: Delirium is widely present within the ICU setting but lacks validated prevention and treatment strategies. By providing patients with virtual reality stimulation presented inside a head-mounted display and noise-cancelling headphones, participants may be isolated from disturbances on an ICU. It is believed that by doing so, the incidence of delirium will be decrease among these patients. Moreover, identifying movement patterns associated with delirium would allow for early detection and intervention, which may further improve long-term negative outcomes associated with delirium during critical care.

Trial registration: ClinicalTrials.gov NCT04498585 . Registered on August 3, 2020.

Keywords: Critical care; Delirium; ICU; Intensive care; Movement patterns; Randomized controlled trial; Virtual reality.

Conflict of interest statement

The Department of Intensive Care Medicine has, or has had in the past, research and development/consulting contracts with Edwards Lifesciences Services GmbH, Phagenesis Limited, and Nestlé. The money was paid into a departmental fund, and none of the authors received any financial gain. The Department of Intensive Care Medicine has received in the past unrestricted educational grants from the following organizations for organizing bi-annual postgraduate courses in the fields of critical care ultrasound, management of ECMO, and mechanical ventilation: Pierre Fabre Pharma AG (formerly known as RobaPharm), Pfizer AG, Bard Medica S.A., Abbott AG, Anandic Medical Systems, PanGas AG Healthcare, Orion Pharma, Bracco, Edwards Lifesciences AG, Hamilton Medical AG, Fresenius Kabi (Schweiz) AG, Getinge Group Maquet AG, Dräger Schweiz AG, and Teleflex Medical GmbH.

None of the authors has any personal conflicts of interest to disclose.

Figures

Fig. 1
Fig. 1
Schedule of enrolment, intervention, and assessments. Arrows represent continuous measurements, and X’s represent an assessment or intervention provided at a specific time point. One asterisk indicates that whenever possible, informed consent will be obtained directly from the patient. If the patient is unable to provide informed consent, we will ask the patients’ relatives and/or an authorized representative for the study consent. Two asterisks indicate that we will ask the patients’ relatives at the earliest possible date, with questions regarding the week prior to arrival at the ICU

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