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

NCT07649876 | Recruiting

• 1 other identifier: STUDY00028621
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Delirium in the Intensive Care Unit; Sleep Quality in Adult ICU Patients; Agitation Associated With Critical Illness; Anxiety Acute

Keywords

Virtual reality; Intensive care unit; Pain; Agitation; Anxiety; Sleep Quality

Outcome Measures

Primary Outcomes (3)

• Feasibility of Intervention Measure (FIM)

  From time of enrollment to end of intervention at 3 days

• Acceptability of Intervention Measure (AIM)

  From time of enrollment to end of intervention at 3 days

• Intervention Appropriateness Measure (IAM)

  From time of enrollment to end of intervention at 3 days

Study Arms (1)

VR Intervention

EXPERIMENTAL

Critically ill patients

Behavioral: Virtual reality (VR) therapy

Interventions

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

VR Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pain; Psychomotor Agitation; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Central Study Contacts

Pauline H Go, MD

CONTACT

717-531-5429; paulinego@pennstatehealth.psu.edu

Aleksandr Davtyan

CONTACT

adavtyan@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

US (1)