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

The Methodist Hospital Research Institute (TMHRI) logo

The Methodist Hospital Research Institute (TMHRI)

Status

Invitation-only

Conditions

Delirium, Post-Operative
Delirium
Surgery

Treatments

Other: Traditional Orientation Methods
Other: Virtual Reality Software

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06232317
R03AG078857 (U.S. NIH Grant/Contract)
PRO00037724

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Virtual Reality Software
Experimental group
Description:
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
Treatment:
Other: Virtual Reality Software
Traditional Orientation Methods
Active Comparator group
Description:
Participants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods,
Treatment:
Other: Traditional Orientation Methods

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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