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. 2024 Dec 18;24(1):917.
doi: 10.1186/s12888-024-06360-4.

Efficacy and safety of a non-immersive virtual reality-based neuropsychological intervention for cognitive stimulation and relaxation in patients with critical illness: study protocol of a randomized clinical trial (RGS-ICU)

Marta Godoy-González  1   2   3 , Josefina López-Aguilar  1   3 , Sol Fernández-Gonzalo  4   5   6 , Gemma Gomà  1   3 , Lluís Blanch  1   3 , Santiago Brandi  7 , Sergi Ramírez  7 , Joel Blasi  7 , Paul Verschure  8 , Gemma Rialp  9   10   11 , Miquel Roca  10   11   12 , Margalida Gili  11   12   13 , Mercè Jodar #  2   14   15 , Guillem Navarra-Ventura #  16   17   18   19
Affiliations

Efficacy and safety of a non-immersive virtual reality-based neuropsychological intervention for cognitive stimulation and relaxation in patients with critical illness: study protocol of a randomized clinical trial (RGS-ICU)

Marta Godoy-González et al. BMC Psychiatry. .

Abstract

Background: Experiencing a critical illness may be a stressful life event that is also associated with cognitive dysfunction during and after the intensive care unit (ICU) stay. A deep-tech solution based on non-immersive virtual reality, gamification and motion capture called Rehabilitation Gaming System for Intensive Care Units (RGS-ICU) has been developed that includes both cognitive stimulation and relaxation protocols specifically designed for patients with critical illness. This study aims to evaluate whether the cognitive and relaxation protocols of the RGS-ICU platform are 1) effective in improving neuropsychological outcomes during and after ICU stay and 2) safe for patients with critical illness.

Methods: This is a study protocol for a multicenter longitudinal randomized clinical trial. At least 80 patients with critical illness will be included: 40 experimental subjects and 40 control subjects. Patients in the experimental group will receive daily 20-min sessions of cognitive stimulation and relaxation with the RGS-ICU platform adjuvant to standard ICU care in their own rooms during the ICU stay and until discharge from the ICU or up to a maximum of 28 days after randomization, provided they are alert and calm. Patients in the experimental group will be constantly monitored as part of standard ICU care to ensure the safety of the intervention and that no avoidable adverse events occur. Patients in the control group will receive standard ICU care. The primary outcome is objective cognition 12 months after ICU discharge, assessed with a composite index including measures of attention, working memory, learning/memory, executive function and processing speed. The secondary outcome is the safety of the intervention, assessed by considering the number of sessions terminated early due to unsafe events in physiological parameters. Other outcomes are comfort experienced during the ICU stay, and subjective cognition, mental health (anxiety, depression and post-traumatic stress disorder), functionality and health-related quality of life 12 months after ICU discharge.

Discussion: The expected results are 1) better neuropsychological outcomes during and after the ICU stay in patients in the experimental group compared to patients in the control group and 2) that the cognitive and relaxation protocols of the RGS-ICU platform are safe for patients with critical illness.

Trial registration: Clinicaltrials.gov NCT06267911. Registered on February 20, 2024.

Keywords: Cognition; Comfort; Critical care; Critical illness; Intensive care unit; Mental health; Post-intensive care syndrome; Prevention; Rehabilitation; Relaxation.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: All procedures contributing to this trial comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. Ethical approval has been provided by the Ethics Committee of the Balearic Islands (Ref. IB 5329/23 PI) and by the Ethics Committee of the Parc Taulí University Hospital (Ref. 2022/3030): protocol version 2 of September 12, 2023. Written informed consent will be obtained from all participants. Consent for publication: Not applicable. Competing interests: J.L.A., S.F.G., L.B., M.J. and G.N.V. are inventors of the ENRIC platform. M.G.G., J.L.A., S.F.G., M.J. and G.N.V. are inventors of the RGS-ICU platform, whose intellectual property is shared with Eodyne Systems S.L. P.V. declares to be the founder and shareholder of Eodyne Systems S.L. The other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Schematic diagram of the RGS-ICU platform, bedside monitor and ventilator. RGS-ICU, Rehabilitation Gaming System for Intensive Care Units
Fig. 2
Fig. 2
Examples of gamified cognitive protocols of the RGS-ICU platform. RGS-ICU, Rehabilitation Gaming System for Intensive Care Units
Fig. 3
Fig. 3
Examples of relaxing protocols of the RGS-ICU platform. RGS-ICU, Rehabilitation Gaming System for Intensive Care Units
Fig. 4
Fig. 4
Types of patient profile according to RASS, CAM-ICU-7 and mobility level. RASS, Richmond Agitation-Sedation Scale; CAM-ICU-7, Confusion Assessment Method for the Intensive Care Unit-7. Patients with a normal level of mobility lift and hold at least one upper extremity straight against gravity without difficulty. Patients with a reduced level of mobility lift and hold the upper extremities straight against gravity with difficulty
Fig. 5
Fig. 5
Timeline of study procedures. ICU, intensive care unit; TAU, treatment as usual; RGS-ICU, Rehabilitation Gaming System for Intensive Care Units
See this image and copyright information in PMC

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