Clinical trial NCT06876168: Virtual Reality in ICU - PARTNER
Official title: Virtual Reality in ICU (PARTNER) - A Research Study About Engaging in Strategies to Promote Relaxation, Improve Your Mood, and Stimulate Thinking in the Intensive Care Setting
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Respiratory Failure
Sepsis
Keywords: virtual reality
intensive care unit
sepsis
acute respiratory failure
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2025-03-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the intensive care unit at University of Kentucky with sepsis or acute respiratory failure.

Brief summary: This project is designed to have patients participate in a virtual environment with various tasks such as breathing exercises, games to help the brain, and techniques that promote relaxation while hospitalized in the Intensive Care Unit (ICU). The participation in research will last about 5 days and take about 15 to 45 minutes each day.

Detailed description: This is a research study about interacting and engaging in strategies to promote relaxation, improve mood, and stimulate thinking in patients in the Intensive Care Unit (ICU) in the hospital; called PARTNER. PARTNER is played by using a readily available Virtual Reality headset while patients are in the ICU. The researchers hope to learn if engaging with exercises for emotional health and cognitive function reduces delirium and loneliness in the hospital. If patients agree, the patients will be asked to play PARNTER, with a Virtual Reality (VR) device to connect them to a virtual environment with games and/or relaxing scenes while in the ICU. The Virtual environment may include things such as breathing exercise, mindfulness training, and relaxation techniques.

Eligibility criteria: Inclusion Criteria:

* Admitted to ICU at University of Kentucky for acute respiratory failure, sepsis or other

Exclusion Criteria:

* Are less than 18 years of age
* Have a pre-existing neurologic disorder
* Have a pre-existing emotional or personality disorder
* Have a history or active mental health disorder or disease
* Experienced an acute neurologic event (e.g., stroke)
* Are currently pregnant
* Are a prisoner
* Receiving hospice care
* Have existing open wounds or pressure ulcers on head or neck

Primary outcomes:
measure: System Usability Scale
timeFrame: From enrollment to end of treatment (5 sessions); Day 1 through Day 5
measure: Completion rate - feasibility
timeFrame: From enrollment to the end of treatment (5 sessions); Day 1 through Day 5
Secondary outcomes:
measure: MoCA
timeFrame: Through study completion, typically occurring at hospital discharge or within 10 days of hospital discharge
measure: Hospital Anxiety and Depression Survey (HADS)
timeFrame: Through study completion, typically occurring at hospital discharge or within 10 days of hospital discharge
measure: IES-R
timeFrame: Through study completion, typically occurring at hospital discharge or within 10 days of hospital discharge
measure: EQ5D
timeFrame: Through study completion, typically occurring at hospital discharge or within 10 days of hospital discharge
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Kirby P. Mayer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: