Virtual Reality to Reduce Anxiety, Agitation and Delirium in Critically Ill Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual reality (VR) therapy.
- Who it may be relevant to
- Registry conditions: Delirium in the Intensive Care Unit, Sleep Quality in Adult ICU Patients, Agitation Associated With Critical Illness, Anxiety Acute. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This is a pilot feasibility study examining the use of immersive virtual reality (VR) in adult intensive care unit (ICU) patients. The study evaluates whether brief, non-interactive VR sessions delivered using a commercially available standalone head-mounted display with calming, nature-based content can be delivered safely and effectively within routine SICU workflow. Exploratory objectives assess whether VR sessions are associated with changes in anxiety, agitation, delirium, pain, and sedative medication requirements. This research is not intended to evaluate the safety or effectiveness of the headset and/or the specific VR software used for the research
Interventions
- Behavioral Virtual reality (VR) therapy
VR sessions will use a commercially available headset with non-interactive, immersive content displaying calming nature-based content (e.g., ocean/beach scenes, forests, mountains) delivered through a commercially available VR application
Primary outcome measures
- Feasibility of Intervention Measure (FIM) [Time frame: From time of enrollment to end of intervention at 3 days]
- Acceptability of Intervention Measure (AIM) [Time frame: From time of enrollment to end of intervention at 3 days]
- Intervention Appropriateness Measure (IAM) [Time frame: From time of enrollment to end of intervention at 3 days]
Eligibility criteria
Inclusion criteria
- Aged ≥ 18 years old admitted to the Surgical Intensive Care Unit (SICU) at Penn State Health Milton S. Hershey Medical Center.
- No significant uncorrectable visual or auditory impairments
- Estimated ICU length of stay > 48h
- At the time of each VR session, able to keep eyes open for at least 30 seconds, follow simple commands and able to indicate discomfort or request to stop.
- English speaking
Exclusion criteria
- Significant hemodynamic instability
- Known psychotic disorders associated with delusions (e.g. schizophrenia)
- Severe dementia (e.g. inability to communicate or follow simple commands)
- History of disequilibrium syndrome or vertigo
- Acute hyperactive delirium, requiring physical restraints
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Penn State Milton S. Hershey Medical Center — Hershey
Publications
- Haley AC, Wacker DA. Cinematic virtual reality for anxiety management in mechanically ventilated patients: a feasibility and pilot study. Acute Crit Care. 2022 May;37(2):230-236. doi: 10.4266/acc.2021.00843. Epub 2022 Feb 4. PMID 35172527
- Locke BW, Tsai TY, Reategui-Rivera CM, Gabriel AS, Smiley A, Finkelstein J. Immersive Virtual Reality Use in Medical Intensive Care: Mixed Methods Feasibility Study. JMIR Serious Games. 2024 Aug 9;12:e62842. doi: 10.2196/62842. PMID 39046869
- Naef AC, Jeitziner MM, Gerber SM, Jenni-Moser B, Muri RM, Jakob SM, Nef T, Hanggi M. Virtual reality stimulation to reduce the incidence of delirium in critically ill patients: study protocol for a randomized clinical trial. Trials. 2021 Mar 1;22(1):174. doi: 10.1186/s13063-021-05090-2. PMID 33648572
- Ong TL, Ruppert MM, Akbar M, Rashidi P, Ozrazgat-Baslanti T, Bihorac A, Suvajdzic M. Improving the Intensive Care Patient Experience With Virtual Reality-A Feasibility Study. Crit Care Explor. 2020 Jun 8;2(6):e0122. doi: 10.1097/CCE.0000000000000122. eCollection 2020 Jun. PMID 32695991
- Jawed YT, Golovyan D, Lopez D, Khan SH, Wang S, Freund C, Imran S, Hameed UB, Smith JP, Kok L, Khan BA. Feasibility of a virtual reality intervention in the intensive care unit. Heart Lung. 2021 Nov-Dec;50(6):748-753. doi: 10.1016/j.hrtlng.2021.05.007. Epub 2021 Jul 1. PMID 34217986
Identifiers
NCT: NCT07649876 · STUDY00028621