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OpenTrials
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NCT Number: NCT07649876

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

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

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Key information

Conditions

Delirium in the Intensive Care Unit Aberrant Motor Behavior in Dementia Agitation Associated With Critical Illness Anxiety Acute Anxiety Disorders Behavior Behavioral Symptoms Dyskinesias Dyssomnias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality in Adult ICU Patients Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location status: Recruiting

Location contact

Aleksandr Davtyan

CONTACT

[email protected]

Pauline Go, MD

CONTACT

[email protected]

7175315429

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksandr Davtyan

CONTACT

[email protected]

Pauline H Go, MD

CONTACT

[email protected]

717-531-5429

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 16, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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