Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients
NCT ID: NCT06232317
Last Updated: 2025-09-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2023-12-09
2024-05-07
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Virtual Reality Software
Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software
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.
Traditional Orientation Methods
Participants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods,
Traditional Orientation Methods
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.
Traditional Orientation Methods
Standard-of-care methods to orient patients after surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
The Methodist Hospital Research Institute
OTHER
Responsible Party
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Hina Faisal
Assistant Professor of Clinical Surgery
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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PRO00037724
Identifier Type: -
Identifier Source: org_study_id
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