Virtual Reality in ICU - PARTNER

Recruiting

• Conditions: Acute Respiratory Failure; Sepsis

• Registration Number: NCT06876168
• Lead Sponsor: Kirby Mayer

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.

Study Timeline

• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-03-13
• Study First Posted: 2025-03-14
• Study Start: 2025-07-02
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-13
• Primary Completion: 2026-07-15
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
System Usability Scale	From enrollment to end of treatment (5 sessions); Day 1 through Day 5	System Usability Scale - describing the ease of use of the procedure and device
Completion rate - feasibility	From enrollment to the end of treatment (5 sessions); Day 1 through Day 5	Feasibility will be defined as the number of sessions completed as compared to the number of days after extubation (or BiPap removal, HFNC removal) and discharge from ICU/hospital.

Secondary Outcome Measures

Name	Time	Method
MoCA	Through study completion, typically occurring at hospital discharge or within 10 days of hospital discharge	Montreal Cognitive Assessment. The Montreal Cognitive Assessment (MoCA) is screening tool for detecting mild cognitive impairment (MCI) and early signs of dementia. It assesses various cognitive domains, including attention, memory, language, visuospatial skills, and executive function.The MoCA Scoring Range: Total Score: 0 to 30, Normal Cognition: 26-30, Mild Cognitive Impairment (MCI): 18-25, Moderate Cognitive Impairment: 10-17, Severe Cognitive Impairment: \<10. A score below 26 generally indicates cognitive impairment, though adjustments may be made for education level (e.g., adding 1 point for individuals with ≤12 years of education). Researchers are trained and certified to give the assessment.
Hospital Anxiety and Depression Survey (HADS)	Through study completion, typically occurring at hospital discharge or within 10 days of hospital discharge	Hospital Anxiety and Depression is an instrument that measures anxiety and depression. The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire designed to assess anxiety and depression in patients, particularly in hospital and clinical settings. It consists of 14 items, divided into two subscales: HADS-A (Anxiety): 7 items HADS-D (Depression): 7 items; Each item is scored from 0 to 3, with a total possible score of 0 to 21 for each subscale. HADS Scoring Range: 0-7: Normal; 8-10: Borderline case (mild symptoms); 11-21: Clinical case (moderate to severe symptoms).
IES-R	Through study completion, typically occurring at hospital discharge or within 10 days of hospital discharge	Impact of Events Scale - Revised (IES_R). The Impact of Event Scale - Revised (IES-R) is a self-report measure used to assess psychological distress and symptoms of post-traumatic stress disorder (PTSD) following a traumatic event. It consists of 22 items, divided into three symptom clusters: 1) Intrusion (8 items) - recurrent thoughts, nightmares, flashbacks; 2) Avoidance (8 items) - emotional numbness, avoiding reminders; 3) Hyperarousal (6 items) - irritability, hypervigilance, difficulty sleeping. The IES-R Scoring Range has a Total Score Range of 0-88 with: 0-23: Minimal impact, 24-32: Mild impact (possible PTSD concern), 33-36: Moderate impact (likely PTSD), ≥37: Severe impact (PTSD highly probable). Higher scores indicate greater distress and a higher likelihood of PTSD. The IES-R is not a diagnostic tool but helps assess symptom severity.
EQ5D	Through study completion, typically occurring at hospital discharge or within 10 days of hospital discharge	The EQ-5D is a standardized, self-reported health-related quality of life (HRQoL) measure developed by the EuroQol Group. It assesses five dimensions of health: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Each dimension is rated on a 5-level (EQ-5D-5L) scale.It also includes a visual analog scale (EQ-VAS), where patients rate their overall health on a 0-100 scale (0 = worst health, 100 = best health).

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States