VR-Based Cognitive Stimulation Games for Delirium Prevention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 65
SponsorThe Methodist Hospital Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pre-existing Intubation and invasive ventilation;
history of severe mental illness;
admission for a drug overdose;
severe vertigo;
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality Software
Other interventionThe 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 movies
Other interventionThis 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 arm
Other interventionReality orientation therapy focused on time, place, and person, administered twice daily, typically at the beginning and end of nursing shifts.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: VR intervention: VR-based cognitive stimulation gamesExperimental treatment 1 intervention
Group B: VR Control: watching a movie in VRExperimental treatment 1 intervention
Group C: Nurse control: standard-of-care nurse-led reality orientationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
Safety of VR-based cognitive stimulation intervention
adverse event
Time frame
Postoperative day 1 -34
Acceptability of VR-based cognitive stimulation intervention
Behavioral intention scale score
Time frame
At Postoperative day 7 or Hospital discharge (whichever comes first)Secondary outcomes
1
Months backward test, pre-intervention
Measurement of attention and working memory (Cognitive outcome)
Time frame
At Post operative day 12
Months backward test, post-intervention
Measurement of attention and working memory
Time frame
At Post-operative Day 33
NIH Flanker test, pre-intervention
Measurement of attention and working memory (Cognitive outcome)
Time frame
At Post operative day 14
NIH Flanker test, post-intervention
Measurement of attention and working memory (Cognitive outcome)
Time frame
At Post operative day 3Other outcomes
1
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Methodist Hospital Research Institute
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov