VR-Based Cognitive Stimulation Games for Delirium Prevention

NCT07641153 | Recruiting

• 2 other identifiers: Pro000411991K76AG088424-01A1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Surgery; Delirium - Postoperative; Delirium

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Months backward test, pre-intervention

  At Post operative day 1

• Months backward test, post-intervention

  At Post-operative Day 3

• NIH Flanker test, pre-intervention

  At Post operative day 1

• NIH Flanker test, post-intervention

  At Post operative day 3

• VR games performances

  At Postoperative day 1, 2 and 3

Other Outcomes (1)

• Effect size of VR cognitive simulation games on postoperative delirium (Exploratory outcome)

  Postoperative day 7 or Hospital discharge (whichever comes first)

Study Arms (3)

VR intervention: VR-based cognitive stimulation games

EXPERIMENTAL

Participants will engage in interactive, VR-based cognitive stimulation games.

Other: Virtual Reality Software

VR Control: watching a movie in VR

EXPERIMENTAL

Participants will watch a non-interactive VR movie experience consisting of educational material.

Other: Virtual Reality movies

Nurse control: standard-of-care nurse-led reality orientation

EXPERIMENTAL

Participants will receive standard-of-care, nurse-led reality orientation therapy.

Other: Nurse led control arm

Interventions

Virtual Reality movies OTHER

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.

VR Control: watching a movie in VR

Virtual Reality Software OTHER

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.

VR intervention: VR-based cognitive stimulation games

Nurse led control arm OTHER

Reality orientation therapy focused on time, place, and person, administered twice daily, typically at the beginning and end of nursing shifts.

Nurse control: standard-of-care nurse-led reality orientation

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Houston Methodist Research Insititute

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hina Faisal, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hina Faisal, MD

CONTACT

346-356-1400; hfaisal@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery, Anesthesia & Critical Care

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 11, 2026
• Study Start: April 24, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)