VR-Based Cognitive Stimulation Games for Delirium Prevention

Virtual Reality-Based Cognitive Stimulation Games for Enhancing Attention and Preventing Delirium in Older Surgical Patients With Cognitive Impairment

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.

Study Overview

• Status: Recruiting
• Conditions: Delirium; Surgery; Delirium - Postoperative
• Intervention / Treatment: Other: Virtual Reality Software; Other: Virtual Reality movies; Other: Nurse led control arm

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hina Faisal, MD; Phone Number: 346-356-1400; Email: hfaisal@houstonmethodist.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Contact: Hina Faisal, MD; Phone Number: 713-448-0343; Email: hfaisal@houstonmethodist.org
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Research Insititute
      • Principal Investigator: Hina Faisal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR intervention: VR-based cognitive stimulation games; Participants will engage in interactive, VR-based cognitive stimulation games.	Other: Virtual Reality Software; The ReCognition virtual reality (VR) software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions. The VR session will occur once per day for 20 minutes.
Experimental: VR Control: watching a movie in VR; Participants will watch a non-interactive VR movie experience consisting of educational material.	Other: Virtual Reality movies; This virtual reality software is delivered via an Oculus Quest 2 device. The Oculus Quest 2 device will be used to watch an educational movie. The VR session will occur once per day for 20 minutes.
Experimental: Nurse control: standard-of-care nurse-led reality orientation; Participants will receive standard-of-care, nurse-led reality orientation therapy.	Other: Nurse led control arm; Reality orientation therapy focused on time, place, and person, administered twice daily, typically at the beginning and end of nursing shifts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the trial and VR-based cognitive stimulation intervention	A composite of recruitment rate, outcomes data completion, usability of VR intervention, acceptance of the VR intervention, and adherence to VR sessions	At Postoperative day 7 or Hospital discharge (whichever comes first)
Adherence of VR-based cognitive stimulation intervention	Number screened, consented, enrolled, and administered VR	Baseline to Postoperative day 7 or Hospital discharge (whichever comes first)
Safety of VR-based cognitive stimulation intervention	adverse event	Postoperative day 1 -3
Acceptability of VR-based cognitive stimulation intervention	Behavioral intention scale score	At Postoperative day 7 or Hospital discharge (whichever comes first)
Usability of VR-based cognitive stimulation intervention	System usability scale score	At Postoperative day 7 or Hospital discharge (whichever comes first)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Months backward test, pre-intervention	Measurement of attention and working memory (Cognitive outcome)	At Post operative day 1
Months backward test, post-intervention	Measurement of attention and working memory	At Post-operative Day 3
NIH Flanker test, pre-intervention	Measurement of attention and working memory (Cognitive outcome)	At Post operative day 1
NIH Flanker test, post-intervention	Measurement of attention and working memory (Cognitive outcome)	At Post operative day 3
VR games performances	Measurement of attention and working memory (Cognitive outcome)	At Postoperative day 1, 2 and 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect size of VR cognitive simulation games on postoperative delirium (Exploratory outcome)	At least one episode of delirium from postoperative day 1 through hospital discharge usinc CAM -ICU screening tool	Postoperative day 7 or Hospital discharge (whichever comes first)

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Hina Faisal, MD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Delirium
• Other Study ID Numbers: Pro00041199; 1K76AG088424-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No