Virtual Reality for Delirium After Surgery

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Must not be taking: Antipsychotics

Disqualifiers: Cognitive impairment, Psychiatric disorders, Deaf, Blind, Seizure disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 2 hours per session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality (VR) can help prevent delirium in older adults after surgery. Researchers compare traditional methods to a VR software called ReCognitionVR to determine which is more effective. They seek participants aged 60 or older, scheduled for certain abdominal surgeries, such as bowel or gallbladder surgery, without cognitive impairments or psychiatric disorders. The goal is to assess whether VR is a safe and acceptable way to support recovery and to inform future studies for critically ill patients. As an unphased trial, this study allows participants to contribute to innovative research that could shape future healthcare solutions.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, if you are being treated with medications for active psychiatric disorders, you may not be eligible to participate.

What prior data suggests that ReCognitionVR is safe for older surgical patients?

Research shows that virtual reality (VR) treatments like ReCognitionVR are generally safe for older adults. Studies have found that VR-based mental exercises are easy to manage. These exercises can help reduce stress, pain, and anxiety, which often occur after surgery.

In trials, participants using ReCognitionVR did not report any serious side effects. Although researchers continue to study VR technology, it appears to be a promising and safe option for older adults. This safety information may ease concerns for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of ReCognitionVR for treating delirium after surgery because it offers a novel approach through virtual reality. Unlike traditional orientation methods, which rely on standard cognitive exercises, ReCognitionVR immerses patients in a virtual environment to enhance cognitive engagement and recovery. This innovative delivery method has the potential to make therapy more interactive and enjoyable, possibly leading to better patient outcomes and faster recovery times.

What evidence suggests that ReCognitionVR is effective for delirium after surgery?

This trial will compare the use of virtual reality software, ReCognitionVR, with traditional orientation methods for reducing delirium after surgery. Research has shown that virtual reality (VR) tools like ReCognitionVR might help reduce post-surgery confusion, though the effect is small. One study found that immersive VR can significantly decrease confusion upon waking from anesthesia compared to other methods. ReCognitionVR is designed to offer mental exercises that might prevent confusion in at-risk patients. While it may not improve short-term memory or cognitive issues, it could alter how patients perceive pain after surgery. These early results suggest potential benefits, but further research is needed to confirm its effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Hina Faisal, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for older patients who have recently undergone surgery and are at risk of developing delirium, a state of confusion. Participants must be able to give consent and follow study procedures. Those with conditions that may interfere with the use of virtual reality or increase risks, such as severe visual impairment or motion sickness, cannot join.

Inclusion Criteria

I am scheduled for a specific type of abdominal surgery.

I am calm and alert, with no agitation or sedation.

I am 60 years old or older.

Exclusion Criteria

Subjects with baseline cognitive impairment

I am currently being treated for a psychiatric disorder, such as schizophrenia.

I am deaf or blind.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive exercises using either traditional orientation methods or ReCognitionVR virtual reality software

Up to 2 hours per session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-emergent adverse events

1 month

What Are the Treatments Tested in This Trial?

Interventions

• ReCognitionVR

Trial Overview The study is testing how practical and acceptable it is to use ReCognitionVR software for cognitive stimulation compared to traditional methods in post-surgery care. It's a preliminary step before a larger trial on preventing delirium in critically ill patients.

How Is the Trial Designed?

Group I: Virtual Reality Software Experimental Treatment 1 Intervention

Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software

Group II: Traditional Orientation Methods Active Control 1 Intervention

Participants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods,

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12152094/

Effects of virtual reality on pain, anxiety, and delirium in ... The meta-analysis indicated that VR interventions led to a very small reduction in postoperative delirium compared to the control group; however ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10673060/

Postoperative Cognitive Impairment and Pain Perception after ... Conclusions: Even if using VR does not alleviate short-term postoperative cognitive impairments, it could affect pain perception. Further ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1089947224001904

Immersive Virtual Reality Versus Video Distraction for the ... Immersive VR distraction significantly reduced the incidence of ED (6.67% in group V vs 40% in group T and 60% in group C), and the incidence of ...

4. database.clin-star.org database.clin-star.org/display/project-5R03AG07885702

Virtual Reality-Based Cognitive Intervention For The ... We propose that "ReCognition" VR -based cognitive intervention will prevent the development of delirium (before it occurs in patients at risk for delirium), ...

5. withpower.com withpower.com/trial/phase-surgery-11-2023-e9f64

Virtual Reality for Delirium After Surgery · Info for Participants This study aims to assess the feasibility, acceptability, and safety of using ReCognitionVR virtual reality-based software in older surgical patients.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06232317

Study Details | NCT06232317 | Feasibility and ... This study aims to assess the feasibility, acceptability, and safety of using ReCognitionVR virtual reality-based software in older surgical patients.

7. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/11215174

Virtual Reality-Based Cognitive Stimulation Games for ... We will test the feasibility and safety of virtual reality-based cognitive stimulation games in older surgical patients at high risk for postoperative delirium.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06999668

Prospective Randomized Controlled Trial of VR Cognitive ... This clinical study investigates whether virtual reality (VR)-based cognitive training can help prevent postoperative delirium (POD) in elderly non-cardiac ...

9. agsjournals.onlinelibrary.wiley.com agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.19181

Virtual reality‐based cognitive exercise games in geriatric ... The aim of the current study was to examine the feasibility, safety, and acceptability of VR-based cognitive exercise games (ReCognitionVR) in older patients ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10266374/

Feasibility of a virtual reality intervention in the intensive ... Virtual reality (VR) stimulation may be a promising intervention because of its capability to reduce psychophysiological stress, pain, and anxiety.