Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients

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.

Study Overview

• Status: Completed
• Conditions: Delirium; Surgery; Delirium, Post-Operative
• Intervention / Treatment: Other: Virtual Reality Software; Other: Traditional Orientation Methods

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Software; Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software	Other: Virtual Reality Software; 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.; Other Names: ReCognitionVR
Active Comparator: Traditional Orientation Methods; Participants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods,	Other: Traditional Orientation Methods; Standard-of-care methods to orient patients after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 1 month of enrolling in the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	Baseline and 10 minutes
Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion	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	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	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	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	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	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)	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)	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start	For participants in the experimental (virtual reality) arm, whether the patient completed 20 minutes of use of the ReCognition VR-based software	20 minutes after the start of software use
Number of Participants With a System Usability Scale (SUS) Score >35	For participants in the experimental (virtual reality) arm, the number of participants with a System Usability Scale (SUS) score >35 on a scale of 0-100, where 0 is minimum and 100 is maximum; higher scores mean better usability.	After completion of use of the virtual reality software, up to 2 hours after the start of software use
Proportion of Participants Completing Game With No Errors	The proportion of participants in the experimental (virtual reality) arm who complete the virtual reality game without any user errors	After completion of use of the virtual reality software, up to 2 hours after the start of software use
Number of Participants Completing Game on First Attempt	For participants in the experimental (virtual reality) arm, the number of participants who complete the virtual reality game in easy mode on the first attempt	After completion of use of the virtual reality software, up to 2 hours after the start of software use

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Hina Faisal, MD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2023
• Primary Completion (Actual): March 21, 2024
• Study Completion (Actual): May 7, 2024

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: virtual reality; abdominal surgery
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Delirium
• Other Study ID Numbers: PRO00037724; R03AG078857 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No