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NCT07641153NARecruiting

VR-Based Cognitive Stimulation Games for Delirium Prevention

The Methodist Hospital Research Institute

Start Date

4/24/2026

Completion Date

5/1/2029

Summary

This trial aims to evaluate the feasibility, safety, and acceptability of a virtual reality (VR)-based cognitive stimulation game to reduce postoperative delirium among older surgical patients at high risk due to pre-existing cognitive impairment.

Detailed Description

Delirium is a sudden, fluctuating disturbance in consciousness and cognition and is highly prevalent in older surgical patients. Delirium is preventable; non-pharmacological interventions, such as cognitive stimulation (CS), are the best preventive strategies. Implementing CS in acute hospital settings is a significant challenge due to limited resources and low patient engagement. Virtual reality (VR) and gamification for CS delivery could be a scalable, engaging solution. Based on my preliminary work, I hypothesize that VR- based CS games will be safe, feasible, and acceptable in high-risk older patients (Aim 1). The proposed study will estimate the intervention's effect on cognitive functions, particularly sustained attention (Aim 2), and the incidence of postoperative delirium (Aim 3). To accomplish the above goals, I will conduct a randomized controlled pilot trial involving 90 patients ≥65 years old with pre-existing cognitive impairment admitted to the hospital following a major surgery. Patients will be randomized 1:1:1 to receive VR-based CS games (intervention), watch a VR movie (VR control), or receive standard-of-care nurse-led reality orientation (Nurse control). The trial will provide me with preliminary data to support an R01 application.

Eligibility Criteria

Age Range: No minimum to 65 years

Inclusion Criteria: * Men and women ≥65 years of age * Have a pre-existing diagnosis of cognitive impairment (Montreal Cognitive Assessment Score of 15-24) * Elective or emergency major surgery with the expectation of admission to the Intensive Care Unit following the surgery for three days following surgery Exclusion Criteria: * Pre-existing Intubation and invasive ventilation; * history of severe mental illness; * admission for a drug overdose; * severe vertigo; * history of severe postoperative nausea and vomiting; * hearing and visual impairment; * preexisting severe dementia (Montreal Cognitive Assessment Score \< 15; and * active delirium at the time of screening for eligibility criteria. * Active suicidal ideation or behavior Screen failure after surgery * Prolonged intubation after surgery (more than 24 hours)

Interventions

OTHER

Virtual Reality Software

OTHER

Virtual Reality movies

OTHER

Nurse led control arm

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Conditions

SurgeryDelirium - PostoperativeDelirium

Locations

Houston Methodist Hospital

Houston, Texas 77030

United States

Houston Methodist Research Insititute

Houston, Texas 77030

United States