An interventional study of Virtual Reality Software and Virtual Reality movies in Surgery, Delirium - Postoperative and Delirium, sponsored by The Methodist Hospital Research Institute. Recruiting at 2 sites in United States. Open to participants aged Up to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by The Methodist Hospital Research Institute · Not applicable, Interventional, and Other
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.
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.
751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
This study's planned enrollment of 90 is below the median of 120 across 464 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →The Methodist Hospital Research Institute is the lead sponsor of 160 studies on the registry; 59 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 18 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will engage in interactive, VR-based cognitive stimulation games.
Other: Virtual Reality Software
Participants will watch a non-interactive VR movie experience consisting of educational material.
Other: Virtual Reality movies
Participants will receive standard-of-care, nurse-led reality orientation therapy.
Other: Nurse led control arm
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.
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.
Reality orientation therapy focused on time, place, and person, administered twice daily, typically at the beginning and end of nursing shifts.
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
Time frame: At Postoperative day 7 or Hospital discharge (whichever comes first)
Adherence of VR-based cognitive stimulation intervention
Number screened, consented, enrolled, and administered VR
Time frame: Baseline to Postoperative day 7 or Hospital discharge (whichever comes first)
Safety of VR-based cognitive stimulation intervention
adverse event
Time frame: Postoperative day 1 -3
Acceptability of VR-based cognitive stimulation intervention
Behavioral intention scale score
Time frame: At Postoperative day 7 or Hospital discharge (whichever comes first)
Usability of VR-based cognitive stimulation intervention
System usability scale score
Time frame: At Postoperative day 7 or Hospital discharge (whichever comes first)
Months backward test, pre-intervention
Measurement of attention and working memory (Cognitive outcome)
Time frame: At Post operative day 1
Months backward test, post-intervention
Measurement of attention and working memory
Time frame: At Post-operative Day 3
NIH Flanker test, pre-intervention
Measurement of attention and working memory (Cognitive outcome)
Time frame: At Post operative day 1
NIH Flanker test, post-intervention
Measurement of attention and working memory (Cognitive outcome)
Time frame: At Post operative day 3
VR games performances
Measurement of attention and working memory (Cognitive outcome)
Time frame: At Postoperative day 1, 2 and 3
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
Time frame: Postoperative day 7 or Hospital discharge (whichever comes first)
Plan to share: No
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