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Peer-reviewedCC BY 4.0JMIR Research Protocols

Immersive Virtual Reality Cognitive Stimulation for Delirium Prevention in Older Surgical Intensive Care Unit Patients With Cognitive Impairment: Protocol for a 3-Arm Randomized Pilot Trial

  • Hina Faisal1,2
  • Kenneth Podell3
  • Austin Shelton4
  • Jiaqiong Xu5
  • Malaz Boustani6,7,8,9,10
  • George Taffet11
11 affiliations
  1. 1Department of Surgery, Houston Methodist, 6550 Fannin Street, Suite SM1661, Houston, TX, 77030, United States, 1-346-238-0343
  2. 2Center for Critical Care, Houston Methodist, Houston, TX, United States
  3. 3Stanley H. Appel Department of Neurology, Houston Methodist, Houston, TX, United States
  4. 4The Bookout Center, Houston Methodist Academic Institute, Houston, TX, United States
  5. 5Center for Health Data Science and Analytics, Houston Methodist Research Institute, Houston, TX, United States
  6. 6Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, United States
  7. 7Center for Aging Research, Indiana University School of Medicine, Indianapolis, IN, United States
  8. 8Regenstrief Institute Inc., Indianapolis, IN, United States
  9. 9Center for Health Innovation and Implementation Science, Indiana University School of Medicine, Indianapolis, IN, United States
  10. 10Eskenazi Health, Health and Hospital Corporation, Indianapolis, IN, United States
  11. 11Department of Medicine, Division of Geriatrics, Houston Methodist Hospital, Indianapolis, IN, United States
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Abstract

Background: Postoperative delirium is common among older adults after major surgery, especially those with cognitive impairment, and is associated with prolonged hospitalization, functional decline, mortality, and subsequent cognitive deterioration. Nonpharmacologic delirium-prevention strategies are recommended but are difficult to deliver reliably in high-acuity environments because they require repeated staff-intensive interactions, consistent patient engagement, and integration into complex intensive care unit (ICU) workflows.

Objective: This study aims to evaluate the feasibility, usability, safety, acceptance, and adherence of ReCognitionVR 2.0, an immersive virtual reality (VR)–based cognitive stimulation intervention designed for older surgical ICU patients with mild-to-moderate cognitive impairment.

Methods: This is a single-center, 3-arm, parallel-group randomized pilot trial. Ninety adults aged 65 years or older undergoing major surgery with expected postoperative ICU admission and Montreal Cognitive Assessment scores of 15 to 24 will be randomized in a 1:1:1 ratio to ReCognitionVR 2.0 cognitive stimulation, passive VR control exposure, or standard-of-care nurse-led reality orientation. VR sessions will be delivered once daily for up to 20 minutes on postoperative days 1 through 3 when participants are calm and alert. The primary outcomes are feasibility metrics, including recruitment, outcome completion, safety and tolerability, usability, acceptance, and adherence. Secondary outcomes estimate preliminary changes in attention and executive function using the Months Backward Test and NIH Toolbox Flanker Inhibitory Control and Attention Test. Postoperative delirium incidence is an exploratory clinical outcome.

Results: This study was funded in September 2025. Participant recruitment and data collection are currently ongoing. Preliminary data quality assessments and exploratory reviews of the collected data are underway. Formal statistical analyses of the trial outcomes will be conducted after participant enrollment is completed and the study database has been finalized and locked. As of July 29, 2026, we had enrolled 18 participants. Early operational experience informed the refinement of exploratory VR performance metrics and the documentation of protocol deviations. Following an oxygen-connection near miss, we added a preintervention oxygen/readiness checklist as an operational safety safeguard. Enrollment of 90 participants is projected to be completed in 2027 if the current recruitment pace is sustained. Results are expected to be published in winter 2027.

Conclusions: This protocol will generate data on feasibility, safety, usability, adherence, digital performance, cognitive assessment, and delirium measurement, all needed to optimize ReCognitionVR 2.0 and to design a future multicenter efficacy trial of VR-enabled delirium prevention in critical care.

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Cite

BibTeXRIS
BibTeX
@article{faisal2026immersive,
  title = {{Immersive Virtual Reality Cognitive Stimulation for Delirium Prevention in Older Surgical Intensive Care Unit Patients With Cognitive Impairment: Protocol for a 3-Arm Randomized Pilot Trial}},
  author = {Hina Faisal and Kenneth Podell and Austin Shelton and Jiaqiong Xu and Malaz Boustani and George Taffet},
  journal = {JMIR Research Protocols},
  year = {2026},
  month = nov,
  doi = {10.2196/105624},
  url = {https://doi.org/10.2196/105624},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Immersive Virtual Reality Cognitive Stimulation for Delirium Prevention in Older Surgical Intensive Care Unit Patients With Cognitive Impairment: Protocol for a 3-Arm Randomized Pilot Trial
AU  - Hina Faisal
AU  - Kenneth Podell
AU  - Austin Shelton
AU  - Jiaqiong Xu
AU  - Malaz Boustani
AU  - George Taffet
PY  - 2026
DA  - 2026/11/05
JO  - JMIR Research Protocols
DO  - 10.2196/105624
UR  - https://doi.org/10.2196/105624
AB  - Background: Postoperative delirium is common among older adults after major surgery, especially those with cognitive impairment, and is associated with prolonged hospitalization, functional decline, mortality, and subsequent cognitive deterioration. Nonpharmacologic delirium-prevention strategies are recommended but are difficult to deliver reliably in high-acuity environments because they require repeated staff-intensive interactions, consistent patient engagement, and integration into complex intensive care unit (ICU) workflows.  Objective: This study aims to evaluate the feasibility, usability, safety, acceptance, and adherence of ReCognitionVR 2.0, an immersive virtual reality (VR)–based cognitive stimulation intervention designed for older surgical ICU patients with mild-to-moderate cognitive impairment.  Methods: This is a single-center, 3-arm, parallel-group randomized pilot trial. Ninety adults aged 65 years or older undergoing major surgery with expected postoperative ICU admission and Montreal Cognitive Assessment scores of 15 to 24 will be randomized in a 1:1:1 ratio to ReCognitionVR 2.0 cognitive stimulation, passive VR control exposure, or standard-of-care nurse-led reality orientation. VR sessions will be delivered once daily for up to 20 minutes on postoperative days 1 through 3 when participants are calm and alert. The primary outcomes are feasibility metrics, including recruitment, outcome completion, safety and tolerability, usability, acceptance, and adherence. Secondary outcomes estimate preliminary changes in attention and executive function using the Months Backward Test and NIH Toolbox Flanker Inhibitory Control and Attention Test. Postoperative delirium incidence is an exploratory clinical outcome.  Results: This study was funded in September 2025. Participant recruitment and data collection are currently ongoing. Preliminary data quality assessments and exploratory reviews of the collected data are underway. Formal statistical analyses of the trial outcomes will be conducted after participant enrollment is completed and the study database has been finalized and locked. As of July 29, 2026, we had enrolled 18 participants. Early operational experience informed the refinement of exploratory VR performance metrics and the documentation of protocol deviations. Following an oxygen-connection near miss, we added a preintervention oxygen/readiness checklist as an operational safety safeguard. Enrollment of 90 participants is projected to be completed in 2027 if the current recruitment pace is sustained. Results are expected to be published in winter 2027.  Conclusions: This protocol will generate data on feasibility, safety, usability, adherence, digital performance, cognitive assessment, and delirium measurement, all needed to optimize ReCognitionVR 2.0 and to design a future multicenter efficacy trial of VR-enabled delirium prevention in critical care.
SN  - 1929-0748
ER  -