SurgeryNCT07641153
VR-Based Cognitive Stimulation Games for Delirium Prevention
A study testing Virtual Reality Software and Virtual Reality movies in people with Surgery and Delirium - Postoperative, run by The Methodist Hospital Research Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Surgery, Delirium - Postoperative, Delirium
- What is being tested?
- Virtual Reality Software and Virtual Reality movies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Apr 2026to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 10Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Hina Faisal, MD, 713-448-0343, hfaisal@houstonmethodist.org
- Recruiting
Houston Methodist Research Insititute
Houston, Texas, 77030
Hina Faisal, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgery, Delirium - Postoperative, Delirium
- Being tested
- Virtual Reality Software, Virtual Reality movies, Nurse led control arm
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality SoftwareOther
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 moviesOther
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 armOther
Reality orientation therapy focused on time, place, and person, administered twice daily, typically at the beginning and end of nursing shifts.
| Study group | Role | What they receive |
|---|---|---|
| VR intervention: VR-based cognitive stimulation games | Experimental | Participants will engage in interactive, VR-based cognitive stimulation games. Receives: 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. Receives: 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. Receives: Other: Nurse led control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At Postoperative day 7 or Hospital discharge (whichever comes first)
Adherence of VR-based cognitive stimulation intervention
Number screened, consented, enrolled, and administered VR
Measured: Baseline to Postoperative day 7 or Hospital discharge (whichever comes first)
Safety of VR-based cognitive stimulation intervention
adverse event
Measured: Postoperative day 1 -3
Acceptability of VR-based cognitive stimulation intervention
Behavioral intention scale score
Measured: At Postoperative day 7 or Hospital discharge (whichever comes first)
Usability of VR-based cognitive stimulation intervention
System usability scale score
Measured: At Postoperative day 7 or Hospital discharge (whichever comes first)
Secondary outcomes (5)
Months backward test, pre-intervention
Measurement of attention and working memory (Cognitive outcome)
Measured: At Post operative day 1
Months backward test, post-intervention
Measurement of attention and working memory
Measured: At Post-operative Day 3
NIH Flanker test, pre-intervention
Measurement of attention and working memory (Cognitive outcome)
Measured: At Post operative day 1
NIH Flanker test, post-intervention
Measurement of attention and working memory (Cognitive outcome)
Measured: At Post operative day 3
VR games performances
Measurement of attention and working memory (Cognitive outcome)
Measured: At Postoperative day 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start24 Apr 2026
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Hina Faisal, The Methodist Hospital Research Institute
- Investigators
- Hina Faisal, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641153
- Sponsor's protocol ID
- Pro00041199
- Other IDs
- 1K76AG088424-01A1
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-Based Cognitive Stimulation Games for Enhancing Attention and Preventing Delirium in Older Surgical Patients With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07641153
- Acronym / sponsor ID
- Pro00041199
- Conditions
- Surgery, Delirium - Postoperative, Delirium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VR intervention: VR-based cognitive stimulation games | Experimental | Other: Virtual Reality SoftwareParticipants will engage in interactive, VR-based cognitive stimulation games. |
| VR Control: watching a movie in VR | Experimental | Other: Virtual Reality moviesParticipants will watch a non-interactive VR movie experience consisting of educational material. |
| Nurse control: standard-of-care nurse-led reality orientation | Experimental | Other: Nurse led control armParticipants will receive standard-of-care, nurse-led reality orientation therapy. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality SoftwareThe 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. | Other | VR intervention: VR-based cognitive stimulation games |
| Virtual Reality moviesThis 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. | Other | VR Control: watching a movie in VR |
| Nurse led control armReality orientation therapy focused on time, place, and person, administered twice daily, typically at the beginning and end of nursing shifts. | Other | Nurse control: standard-of-care nurse-led reality orientation |
Primary outcome
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
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
Safety of VR-based cognitive stimulation intervention
Time frame: Postoperative day 1 -3
adverse event
Acceptability of VR-based cognitive stimulation intervention
Time frame: At Postoperative day 7 or Hospital discharge (whichever comes first)
Behavioral intention scale score
Usability of VR-based cognitive stimulation intervention
Time frame: At Postoperative day 7 or Hospital discharge (whichever comes first)
System usability scale score
5 secondary outcomes
Months backward test, pre-intervention
Time frame: At Post operative day 1
Months backward test, post-intervention
Time frame: At Post-operative Day 3
NIH Flanker test, pre-intervention
Time frame: At Post operative day 1
NIH Flanker test, post-intervention
Time frame: At Post operative day 3
VR games performances
Time frame: At Postoperative day 1, 2 and 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hina Faisal, MD principal investigator
The Methodist Hospital Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Software and Virtual Reality movies in people with Surgery and Delirium - Postoperative, run by The Methodist Hospital Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hina Faisal, MD (346-356-1400, hfaisal@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.