Clinical trial NCT06232317: Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients
Official title: Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Surgery
Delirium
Delirium, Post-Operative
Keywords: abdominal surgery
virtual reality
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* ≥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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of treatment-emergent adverse events (TEAE)
timeFrame: Within 1 month of enrolling in the study
Secondary outcomes:
measure: Change From Baseline in Pulse Oximetry Oxygen Saturation after 10 Minutes
timeFrame: Baseline and 10 minutes
measure: Change from baseline in respiratory rate after 10 minutes
timeFrame: Baseline and 10 minutes
measure: Change from baseline in systolic blood pressure after 10 minutes
timeFrame: Baseline and 10 minutes
measure: Change from baseline in diastolic blood pressure after 10 minutes
timeFrame: Baseline and 10 minutes
measure: Change from baseline in pulse oximetry oxygen saturation after completion
timeFrame: Baseline and completion of the intervention, up to 2 hours
measure: Change from baseline in respiratory rate after completion
timeFrame: Baseline and completion of the intervention, up to 2 hours
measure: Change from baseline in systolic blood pressure after completion
timeFrame: Baseline and completion of the intervention, up to 2 hours
measure: Change from baseline in diastolic blood pressure after completion
timeFrame: Baseline and completion of the intervention, up to 2 hours
measure: Positive Confusion Assessment Method and/or 4 A's Test
timeFrame: Baseline, 24 hours, 48 hours, 72 hours
Other outcomes:
measure: Percentage of Participants Using Virtual Reality Software at 20 Minutes after Start
timeFrame: 20 minutes after the start of software use
measure: Participants With a System Usability Scale Score >35
timeFrame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
measure: Proportion of Participants Completing Game with No Errors
timeFrame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
measure: Number of Attempts to Complete the Game
timeFrame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
measure: Number of Software and Device Restarts
timeFrame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
measure: Number of Software and Device Resets
timeFrame: After completion of use of the virtual reality software, up to 2 hours after the start of software use
Locations:
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Hina Faisal, MD
role: PRINCIPAL_INVESTIGATOR
References: