Virtual Reality to Reduce Anxiety, Agitation and Delirium in Critically Ill Patients (NCT07649876) | Clinical Trial Compass
RecruitingNot Applicable
Virtual Reality to Reduce Anxiety, Agitation and Delirium in Critically Ill Patients
United States30 participantsStarted 2026-06-02
Plain-language summary
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
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is focused on feasibility, acceptability, and appropriateness rather than directly measuring whether VR actually reduces anxiety or delirium outcomes, what does that mean for what we'd realistically learn or gain from participating?
2Given that this study involves delivering virtual reality to critically ill ICU patients, what specific safety concerns have been identified around using VR headsets in that setting, such as infection risk, sensory overstimulation, or worsening agitation?
3Since the trial is still in an early feasibility stage, is there any existing evidence my doctor finds convincing that VR could genuinely help with ICU anxiety or delirium, or is this still largely exploratory territory?
4How would participating in this trial interact with or delay standard ICU care for managing agitation and delirium, such as sedation medications or other established protocols?
5What kinds of patients are typically considered unsuitable for this type of VR intervention in the ICU, and are there any aspects of my specific condition that might make participation risky or impractical?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Intervention Measure (FIM)
Timeframe: From time of enrollment to end of intervention at 3 days
2
Acceptability of Intervention Measure (AIM)
Timeframe: From time of enrollment to end of intervention at 3 days
3
Intervention Appropriateness Measure (IAM)
Timeframe: From time of enrollment to end of intervention at 3 days