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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
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.
Standard-of-care methods to orient patients after surgery
Houston Methodist Research Institute
Houston, Texas, United States
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.
Time frame: Within 1 month of enrolling in the study
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 10 minutes
Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion
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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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
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)