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NCT Number: NCT07641153

VR-Based Cognitive Stimulation Games for Delirium Prevention

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.

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Key information

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Methodist Hospital, Houston, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Feasibility of the trial and VR-based cognitive stimulation intervention

    Time frame: At Postoperative day 7 or Hospital discharge (whichever comes first)

    A composite of recruitment rate, outcomes data completion, usability of VR intervention, acceptance of the VR intervention, and adherence to VR sessions

  2. Adherence of VR-based cognitive stimulation intervention

    Time frame: Baseline to Postoperative day 7 or Hospital discharge (whichever comes first)

    Number screened, consented, enrolled, and administered VR

  3. Safety of VR-based cognitive stimulation intervention

    Time frame: Postoperative day 1 -3

    adverse event

  4. Acceptability of VR-based cognitive stimulation intervention

    Time frame: At Postoperative day 7 or Hospital discharge (whichever comes first)

    Behavioral intention scale score

  5. Usability of VR-based cognitive stimulation intervention

    Time frame: At Postoperative day 7 or Hospital discharge (whichever comes first)

    System usability scale score

Secondary outcomes

  1. Months backward test, pre-intervention

    Time frame: At Post operative day 1

    Measurement of attention and working memory (Cognitive outcome)

  2. Months backward test, post-intervention

    Time frame: At Post-operative Day 3

    Measurement of attention and working memory

  3. NIH Flanker test, pre-intervention

    Time frame: At Post operative day 1

    Measurement of attention and working memory (Cognitive outcome)

  4. NIH Flanker test, post-intervention

    Time frame: At Post operative day 3

    Measurement of attention and working memory (Cognitive outcome)

  5. VR games performances

    Time frame: At Postoperative day 1, 2 and 3

    Measurement of attention and working memory (Cognitive outcome)

Other outcomes

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

    Time frame: Postoperative day 7 or Hospital discharge (whichever comes first)

    At least one episode of delirium from postoperative day 1 through hospital discharge usinc CAM -ICU screening tool

Study contacts

Contact information is provided by the study sponsor or research team.

Hina Faisal, MD

CONTACT

[email protected]

346-356-1400

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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