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

NCT06232317 | Completed Results

• 2 other identifiers: PRO00037724R03AG078857
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Delirium; Delirium, Post-Operative

Keywords

abdominal surgery; virtual reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes

  Baseline and 10 minutes

• Change From Baseline in Respiratory Rate After 10 Minutes

  Baseline and 10 minutes

• Change From Baseline in Systolic Blood Pressure After 10 Minutes

  Baseline and 10 minutes

• Change From Baseline in Diastolic Blood Pressure After 10 Minutes

  Baseline and 10 minutes

• Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion

  Baseline and completion of the intervention, up to 2 hours

Other Outcomes (4)

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

  20 minutes after the start of software use

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

  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

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

Study Arms (2)

Virtual Reality Software

EXPERIMENTAL

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

Other: Virtual Reality Software

Traditional Orientation Methods

ACTIVE COMPARATOR

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

Other: Traditional Orientation Methods

Interventions

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.

Also known as: ReCognitionVR

Virtual Reality Software

Traditional Orientation Methods OTHER

Standard-of-care methods to orient patients after surgery

Traditional Orientation Methods

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Delirium; Emergence Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes

Results Point of Contact

• Title: Dr. Hina Faisal
• Organization: Department of Surgery, Houston Methodist Hospital

hfaisal@houstonmethodist.org

713-714-4973

Study Officials

• Hina Faisal, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Surgery

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 30, 2024
• Study Start: December 9, 2023
• Primary Completion: March 21, 2024
• Study Completion: May 7, 2024
• Last Updated: September 17, 2025
• Results First Posted: September 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)