Recruiting

Virtual Reality

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT07641153

Conditions

Surgery

Delirium - Postoperative

Delirium

Eligibility Criteria

Sex: All

Age: 0 - 65

Healthy Volunteers: Not accepted

Interventions

Virtual Reality Software

Virtual Reality movies

Nurse led control arm

Study Details

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

Study ID

NCT07641153

Start date

Apr 24, 2026

Status verified date

Jun, 2026

Completion date

May 1, 2029

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: VR intervention: VR-based cognitive stimulation games

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

experimental: VR Control: watching a movie in VR

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

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

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

Interventions

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.

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.

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.

Primary outcome measure

  • Feasibility of the trial and VR-based cognitive stimulation intervention [ Time Frame: At Postoperative day 7 or Hospital discharge (whichever comes first) ]
  • Adherence of VR-based cognitive stimulation intervention [ Time Frame: Baseline to Postoperative day 7 or Hospital discharge (whichever comes first) ]
  • Safety of VR-based cognitive stimulation intervention [ Time Frame: Postoperative day 1 -3 ]
  • Acceptability of VR-based cognitive stimulation intervention [ Time Frame: At Postoperative day 7 or Hospital discharge (whichever comes first) ]
  • Usability of VR-based cognitive stimulation intervention [ Time Frame: At Postoperative day 7 or Hospital discharge (whichever comes first) ]

Central Contacts and Locations

Central contacts

Hina Faisal, MD

346-356-1400hfaisal@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Hina Faisal, MD

713-448-0343hfaisal@houstonmethodist.org

Houston Methodist Research Insititute

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Hina Faisal, MD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-06-11.