SurgeryNCT06232317
Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients
A study testing Virtual Reality Software and Traditional Orientation Methods in people with Surgery and Delirium, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
This study aims to assess the feasibility, acceptability, and safety of using ReCognitionVR virtual reality-based software in older surgical patients. Results from this study will be used to inform the design of a future study in critically ill hospitalized patients at risk for delirium. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Surgery, Delirium, Delirium, Post-Operative
- What is being tested?
- Virtual Reality Software and Traditional Orientation Methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2023to 7 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥60 years of age
- Scheduled to undergo the following abdominal surgeries (open or laparoscopic or robotic assisted): small bowel and large bowel surgery; cholecystectomy; Whipple procedure; pancreatectomy; splenectomy.
- Richmond Agitation-Sedation Scale (RASS) Score 0
Who cannot join
- Subjects with baseline cognitive impairment
- Person with active psychiatric disorders and being treated with medications, especially schizophrenia
- Person who is deaf or blind
- Person with an underlying cognitive disorder or associated phobias (e.g., claustrophobia)
- Person participating in other clinical trials involving drugs, biologics, devices, or behavioral interventions
- Active seizure disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Methodist Research Institute
Houston, Texas, 77030
About this study
This study aims to assess the feasibility, acceptability, and safety of using ReCognitionVR virtual reality-based software in older surgical patients. Results from this study will be used to inform the design of a future study in critically ill hospitalized patients at risk for delirium.
Read the detailed description
Virtual reality (VR) imitates reality by creating an artificial 3-dimensional (3D) environment using computing technology or software. A virtual environment (VE) is created using this software with a headset, which cognitively stimulates the user's brain to think they are in an artificial world. Creating a VE allows flexibility and measurement of different types of stimuli while recording the various responses provided by users in the controlled VE. VR strengthens the brain's ability to focus, learn, and retain experience. VR for attention deficit disorders has been reported to have promising results. We followed in similar footsteps and designed and developed a novel, 3D simulated software platform prototype called ReCognition VR to provide VR-based cognitive exercises.
A feasibility clinical trial conducted by our group tested the ReCognitionVR cognitive interventions on older and young healthy volunteers (NCT05583903). The results of this study showed that ReCognitionVR-based cognitive exercises were feasible, acceptable, and tolerable by older healthy subjects. In stage 2 of our research study, we want to evaluate the safety, feasibility, acceptability, and tolerability of VR-based cognitive exercises in 60-year-old or older patients following abdominal surgery admitted to the surgical floor at Houston Methodist Hospital (HMH). Our premise is that VR-based cognitive stimulation software will allow the controlled delivery of structured cognitive exercises focusing on orientation, attention, memory, and executive functions. The system will allow customized frequency and duration of cognitive exercises based on the users' difficulty level in a delightfully relaxed environment with beach wave sounds.
- Conditions
- Surgery, Delirium, Delirium, Post-Operative
- Being tested
- Virtual Reality Software, Traditional Orientation Methods
- Keywords
- abdominal surgery, virtual reality
- Medical subject headings
- Delirium, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality SoftwareOther
Also called ReCognitionVR
The ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.
Traditional Orientation MethodsOther
Standard-of-care methods to orient patients after surgery
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Software | Experimental | Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software Receives: Other: Virtual Reality Software |
| Traditional Orientation Methods | Active comparator | Participants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods, Receives: Other: Traditional Orientation Methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE)
Percentage of participants who experience a treatment-emergent adverse event (TEAE) in the virtual reality software (experimental) arm compared to the Traditional Orientation Methods (control) arm.
Measured: Within 1 month of enrolling in the study
Secondary outcomes (11)
Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes
Pulse oximetry oxygen saturation measured using a vital sign monitor at baseline (immediately prior to VR software use and 10 minutes after VR software use. Change = 10-minute oxygen saturation - baseline oxygen saturation
Measured: Baseline and 10 minutes
Change From Baseline in Respiratory Rate After 10 Minutes
Respiratory rate at baseline (immediately prior to virtual reality software use and 10 minutes after use. Change = 10-minute respiratory rate - baseline respiratory rate
Measured: Baseline and 10 minutes
Change From Baseline in Systolic Blood Pressure After 10 Minutes
Systolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and 10 minutes after software use. Change = 10-minute systolic blood pressure - baseline systolic blood pressure
Measured: Baseline and 10 minutes
Change From Baseline in Diastolic Blood Pressure After 10 Minutes
Diastolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and 10 minutes after software use. Change = 10-minute diastolic blood pressure - baseline diastolic blood pressure
Measured: Baseline and 10 minutes
Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion
Pulse oximetry oxygen saturation measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and after completion of software use. Change = completion oxygen saturation - baseline oxygen saturation
Measured: Baseline and completion of the intervention, up to 2 hours
Change From Baseline in Respiratory Rate After Completion
Respiratory rate at baseline (immediately prior to virtual reality software use) and after software use. Change = completion respiratory rate - baseline respiratory rate
Measured: Baseline and completion of the intervention, up to 2 hours
Change From Baseline in Systolic Blood Pressure After Completion
Systolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and after completion of software use. Change = completion systolic blood pressure - baseline systolic blood pressure
Measured: Baseline and completion of the intervention, up to 2 hours
Change From Baseline in Diastolic Blood Pressure After Completion
Diastolic blood pressure measured using a vital sign monitor at baseline (immediately prior to virtual reality software use) and after software use. Change = completion diastolic blood pressure - baseline diastolic blood pressure
Measured: Baseline and completion of the intervention, up to 2 hours
Positive Confusion Assessment Method and/or 4 A's Test
The proportion of patients who have a positive Confusion Assessment Method (CAM) or 4 A's Test for delirium
Measured: Baseline to discharge from hospital, up to 3 months
Change in Visual Analog Scale (VAS) Pain Score
Change in VAS pain score using numeric pain rating scale, where 0 is minimum (no pain) and 10 is maximum (highest pain), from start of intervention to end of intervention (experimental arm) or enrollment to 24 hours post-enrollment (control arm)
Measured: Enrollment in study to 24 hours after study enrollment
Change in Virtual Analog Scale (VAS) Pain Score Value Beginning to Mid-intervention
Change in VAS pain score using numeric pain rating scale, where 0 is minimum (no pain) and 10 is maximum (highest pain), from pre-virtual reality use to 10 minutes after beginning use (experimental arm) or enrollment to 8-16 hours post-enrollment (control arm)
Measured: Virtual Reality Software arm: 10 minutes after beginning use; Traditional Orientation Methods arm: 8-16 hours after enrollment (one measure, window allowed for completing the measure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start9 Dec 2023
- Primary completion21 Mar 2024
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
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
- NCT06232317
- Sponsor's protocol ID
- PRO00037724
- Other IDs
- R03AG078857
- Status last verified
- Aug 2025
- First submitted
- 22 Jan 2024
- Last updated
- 17 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients
- ClinicalTrials.gov ID
- NCT06232317
- Acronym / sponsor ID
- PRO00037724
- Conditions
- Surgery, Delirium, Delirium, Post-Operative
- Keywords
- abdominal surgery, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 9 Dec 2023 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Posted 17 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the feasibility, acceptability, and safety of using ReCognitionVR virtual reality-based software in older surgical patients. Results from this study will be used to inform the design of a future study in critically ill hospitalized patients at risk for delirium.
Detailed description
Virtual reality (VR) imitates reality by creating an artificial 3-dimensional (3D) environment using computing technology or software. A virtual environment (VE) is created using this software with a headset, which cognitively stimulates the user's brain to think they are in an artificial world. Creating a VE allows flexibility and measurement of different types of stimuli while recording the various responses provided by users in the controlled VE. VR strengthens the brain's ability to focus, learn, and retain experience. VR for attention deficit disorders has been reported to have promising results. We followed in similar footsteps and designed and developed a novel, 3D simulated software platform prototype called ReCognition VR to provide VR-based cognitive exercises.
A feasibility clinical trial conducted by our group tested the ReCognitionVR cognitive interventions on older and young healthy volunteers (NCT05583903). The results of this study showed that ReCognitionVR-based cognitive exercises were feasible, acceptable, and tolerable by older healthy subjects. In stage 2 of our research study, we want to evaluate the safety, feasibility, acceptability, and tolerability of VR-based cognitive exercises in 60-year-old or older patients following abdominal surgery admitted to the surgical floor at Houston Methodist Hospital (HMH). Our premise is that VR-based cognitive stimulation software will allow the controlled delivery of structured cognitive exercises focusing on orientation, attention, memory, and executive functions. The system will allow customized frequency and duration of cognitive exercises based on the users' difficulty level in a delightfully relaxed environment with beach wave sounds.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Software | Experimental | Other: Virtual Reality SoftwareParticipants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software |
| Traditional Orientation Methods | Active comparator | Other: Traditional Orientation MethodsParticipants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods, |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥60 years of age
- Scheduled to undergo the following abdominal surgeries (open or laparoscopic or robotic assisted): small bowel and large bowel surgery; cholecystectomy; Whipple procedure; pancreatectomy; splenectomy.
- Richmond Agitation-Sedation Scale (RASS) Score 0
Key exclusion criteria (6 listed)
- Subjects with baseline cognitive impairment
- Person with active psychiatric disorders and being treated with medications, especially schizophrenia
- Person who is deaf or blind
- Person with an underlying cognitive disorder or associated phobias (e.g., claustrophobia)
- Person participating in other clinical trials involving drugs, biologics, devices, or behavioral interventions
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 SoftwareAlso: ReCognitionVRThe ReCognitionVR virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions. | Other | Virtual Reality Software |
| Traditional Orientation MethodsStandard-of-care methods to orient patients after surgery | Other | Traditional Orientation Methods |
Primary outcome
Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE)
Time frame: Within 1 month of enrolling in the study
Percentage of participants who experience a treatment-emergent adverse event (TEAE) in the virtual reality software (experimental) arm compared to the Traditional Orientation Methods (control) arm.
11 secondary outcomes
Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes
Time frame: Baseline and 10 minutes
Change From Baseline in Respiratory Rate After 10 Minutes
Time frame: Baseline and 10 minutes
Change From Baseline in Systolic Blood Pressure After 10 Minutes
Time frame: Baseline and 10 minutes
Change From Baseline in Diastolic Blood Pressure After 10 Minutes
Time frame: Baseline and 10 minutes
Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion
Time frame: Baseline and completion of the intervention, up to 2 hours
Change From Baseline in Respiratory Rate After Completion
Time frame: Baseline and completion of the intervention, up to 2 hours
Change From Baseline in Systolic Blood Pressure After Completion
Time frame: Baseline and completion of the intervention, up to 2 hours
Change From Baseline in Diastolic Blood Pressure After Completion
Time frame: Baseline and completion of the intervention, up to 2 hours
Positive Confusion Assessment Method and/or 4 A's Test
Time frame: Baseline to discharge from hospital, up to 3 months
Change in Visual Analog Scale (VAS) Pain Score
Time frame: Enrollment in study to 24 hours after study enrollment
Change in Virtual Analog Scale (VAS) Pain Score Value Beginning to Mid-intervention
Time frame: Virtual Reality Software arm: 10 minutes after beginning use; Traditional Orientation Methods arm: 8-16 hours after enrollment (one measure, window allowed for completing the measure)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Hina Faisal, MD principal investigator
The Methodist Hospital Research Institute
1 site 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 Traditional Orientation Methods in people with Surgery and Delirium, run by The Methodist Hospital Research Institute at 1 site 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 6 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: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 17 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE) (time frame: Within 1 month of enrolling in the study). 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 17 Sep 2025.