Virtual Reality to Reduce Anxiety, Agitation and Delirium in Critically Ill Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMilton S. Hershey Medical Center

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Virtual reality (VR) therapy

    Behavioral

    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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: VR InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of Intervention Measure (FIM)

Time frame
From time of enrollment to end of intervention at 3 days
2

Acceptability of Intervention Measure (AIM)

Time frame
From time of enrollment to end of intervention at 3 days
3

Intervention Appropriateness Measure (IAM)

Time frame
From time of enrollment to end of intervention at 3 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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