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

NCT ID: NCT06232317

Last Updated: 2025-09-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-09

Study Completion Date

2024-05-07

Brief Summary

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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

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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.

Conditions

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Surgery Delirium Delirium, Post-Operative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Virtual Reality Software

Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software

Group Type EXPERIMENTAL

Virtual Reality Software

Intervention Type 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.

Traditional Orientation Methods

Participants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods,

Group Type ACTIVE_COMPARATOR

Traditional Orientation Methods

Intervention Type OTHER

Standard-of-care methods to orient patients after surgery

Interventions

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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.

Intervention Type OTHER

Traditional Orientation Methods

Standard-of-care methods to orient patients after surgery

Intervention Type OTHER

Other Intervention Names

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ReCognitionVR

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

The Methodist Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Hina Faisal

Assistant Professor of Clinical Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hina Faisal, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

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Houston Methodist Research Institute

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R03AG078857

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO00037724

Identifier Type: -

Identifier Source: org_study_id

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