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Completed

NCT Number: NCT06232317

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.

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Key information

Conditions

Surgery Confusion Delirium Delirium, Post-Operative Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Software

Other

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

Traditional Orientation Methods

Other

Standard-of-care methods to orient patients after surgery

Primary outcomes

  1. Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE)

    Time frame: Within 1 month of enrolling in the study

    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.

Secondary outcomes

  1. Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes

    Time frame: Baseline and 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

  2. Change From Baseline in Respiratory Rate After 10 Minutes

    Time frame: Baseline and 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

  3. Change From Baseline in Systolic Blood Pressure After 10 Minutes

    Time frame: Baseline and 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

  4. Change From Baseline in Diastolic Blood Pressure After 10 Minutes

    Time frame: Baseline and 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

  5. Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion

    Time frame: Baseline and completion of the intervention, up to 2 hours

    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

  6. Change From Baseline in Respiratory Rate After Completion

    Time frame: Baseline and completion of the intervention, up to 2 hours

    Respiratory rate at baseline (immediately prior to virtual reality software use) and after software use. Change = completion respiratory rate - baseline respiratory rate

  7. Change From Baseline in Systolic Blood Pressure After Completion

    Time frame: Baseline and completion of the intervention, up to 2 hours

    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

  8. Change From Baseline in Diastolic Blood Pressure After Completion

    Time frame: Baseline and completion of the intervention, up to 2 hours

    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

  9. Positive Confusion Assessment Method and/or 4 A's Test

    Time frame: Baseline to discharge from hospital, up to 3 months

    The proportion of patients who have a positive Confusion Assessment Method (CAM) or 4 A's Test for delirium

  10. Change in Visual Analog Scale (VAS) Pain Score

    Time frame: Enrollment in study to 24 hours after study enrollment

    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)

  11. Change in Virtual Analog Scale (VAS) Pain Score Value Beginning to Mid-intervention

    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)

    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)

Other outcomes

  1. Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start

    Time frame: 20 minutes after the start of software use

    For participants in the experimental (virtual reality) arm, whether the patient completed 20 minutes of use of the ReCognition VR-based software

  2. Number of Participants With a System Usability Scale (SUS) Score >35

    Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use

    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.

  3. Proportion of Participants Completing Game With No Errors

    Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use

    The proportion of participants in the experimental (virtual reality) arm who complete the virtual reality game without any user errors

  4. Number of Participants Completing Game on First Attempt

    Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use

    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

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2024
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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