Virtual Reality in ICU - PARTNER
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorKirby Mayer
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Admitted to ICU at University of Kentucky for acute respiratory failure, sepsis or other
Disqualifiers
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
Trial population
Patients in the intensive care unit at University of Kentucky with sepsis or acute respiratory failure.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
32 Participants
are grouped into 1 trial groupGroup A: VR-PARTNER
Trial outcomes
Primary outcomes
1
System Usability Scale
System Usability Scale - describing the ease of use of the procedure and device
Time frame
From enrollment to end of treatment (5 sessions); Day 1 through Day 52
Completion rate - feasibility
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.
Time frame
From enrollment to the end of treatment (5 sessions); Day 1 through Day 5Secondary outcomes
1
MoCA
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.
Time frame
Through study completion, typically occurring at hospital discharge or within 10 days of hospital discharge2
Hospital Anxiety and Depression Survey (HADS)
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).
Time frame
Through study completion, occurring at the time of hospital discharge, or at a 10, 30, or 60-day post-hospital discharge follow-up, conducted either at the ICU Recovery Clinic or by telephone.3
IES-R
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.
Time frame
Through study completion, occurring at the time of hospital discharge, or at a 10, 30, or 60-day post-hospital discharge follow-up, conducted either at the ICU Recovery Clinic or by telephone.4
EQ5D
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).
Time frame
Through study completion, typically occurring at hospital discharge or within 10 days of hospital dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kirby Mayer
Lead sponsor
University of Kentucky
Sponsor institution
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov