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Virtual Reality for Delirium After Surgery

N/A
Waitlist Available
Led By Hina Faisal, MD
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled to undergo the following abdominal surgeries (open or laparoscopic or robotic assisted): small bowel and large bowel surgery; cholecystectomy; Whipple procedure; pancreatectomy; splenectomy.
≥60 years of age
Must not have
Person with active psychiatric disorders and being treated with medications, especially schizophrenia
Person who is deaf or blind
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes after the start of software use
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if using virtual reality software called ReCognitionVR is possible, liked by patients, and safe for older people who have had surgery. The results will help plan a future study for

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly stated, potential side effects might include discomfort from wearing VR equipment, temporary dizziness or nausea due to virtual reality exposure (known as 'cybersickness'), and eye strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a specific type of abdominal surgery.
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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for a psychiatric disorder, such as schizophrenia.
Select...
I am deaf or blind.
Select...
I have seizures that are currently not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes after the start of software use
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minutes after the start of software use for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of treatment-emergent adverse events (TEAE)
Secondary study objectives
Change From Baseline in Pulse Oximetry Oxygen Saturation after 10 Minutes
Change from baseline in diastolic blood pressure after 10 minutes
Change from baseline in diastolic blood pressure after completion
+6 more
Other study objectives
Number of Attempts to Complete the Game
Number of Software and Device Resets
Number of Software and Device Restarts
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Reality SoftwareExperimental Treatment1 Intervention
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Group II: Traditional Orientation MethodsActive Control1 Intervention
Participants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods,

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
285 Previous Clinical Trials
81,656 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,788 Previous Clinical Trials
28,184,483 Total Patients Enrolled
37 Trials studying Delirium
39,217 Patients Enrolled for Delirium
Hina Faisal, MDPrincipal InvestigatorThe Methodist Hospital Research Institute
~16 spots leftby Nov 2025
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