Immersive Virtual Reality Cognitive Stimulation for Delirium Prevention in Older Surgical ICU Patients With Cognitive Impairment: Protocol for a Three-Arm Randomized Pilot Trial (Preprint)
Year: 2026
Type: article
Study design: Study Protocol
Abstract: BACKGROUND Postoperative delirium is common among older adults after major surgery, especially those with cognitive impairment, and is associated with prolonged hospitalization, functional decline, mortality, and subsequent cognitive deterioration. Nonpharmacologic delirium-prevention strategies are recommended but are difficult to deliver reliably in high-acuity environments because they require repeated staff-intensive interactions, consistent patient engagement, and integration into complex ICU workflows. OBJECTIVE This study aims to evaluate the feasibility, usability, safety, acceptance, and adherence of ReCognitionVR 2.0, an immersive virtual reality (VR)-based cognitive stimulation intervention designed for older surgical ICU patients with mild-to-moderate cognitive impairment. METHODS This is a single-center, three-arm, parallel-group randomized pilot trial. Ninety adults aged 65 years or older undergoing major surgery with expected postoperative ICU admission and Montreal Cognitive Assessment scores of 15 to 24 will be randomized in a 1:1:1 ratio to ReCognitionVR 2.0 cognitive stimulation, passive VR control exposure, or standard-of-care nurse-led reality orientation. VR sessions will be delivered once daily for up to 20 minutes on postoperative days 1 through 3 when participants are calm and alert. The primary outcomes are feasibility metrics, including recruitment, outcome completion, safety and tolerability, usability, acceptance, and adherence. Secondary outcomes estimate preliminary changes in attention and executive function using the Months Backward Test and NIH Toolbox Flanker Inhibitory Control and Attention Test. Postoperative delirium incidence is an exploratory clinical outcome. RESULTS The modified protocol was approved as version 2 on April 13, 2026. Enrollment began on April 24, 2026. As of June 12, 2026, 18 participants had been enrolled, and early operational experience had informed prespecified implementation refinements, including clarification of VR performance metrics, documentation of protocol deviations, and addition of a preintervention oxygen/readiness checklist. Enrollment of 90 participants is projected to be completed in 2027 if the current recruitment pace is sustained. CONCLUSIONS This protocol will generate feasibility, safety, usability, adherence, digital performance, cognitive assessment, and delirium measurement data needed to optimize ReCognitionVR 2.0 and to design a future multicenter efficacy trial of VR-enabled delirium prevention in critical care. CLINICALTRIAL ClinicalTrials.gov [NCT07641153]; ClinicalTrials.gov PRS: Record Summary NCT07641153.
Source: JMIR Research Protocols
DOI: 10.2196/105624
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,900
OpenAlex ID: W7214740249