Virtual Reality in ICU - PARTNER

NCT06876168 | Recruiting DMC

• 2 other identifiers: 97957R43AT013038
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure; Sepsis

Keywords

virtual reality; intensive care unit; sepsis; acute respiratory failure

Outcome Measures

Primary Outcomes (2)

• System Usability Scale

  System Usability Scale - describing the ease of use of the procedure and device

  From enrollment to end of treatment (5 sessions); Day 1 through Day 5

• 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.

  From enrollment to the end of treatment (5 sessions); Day 1 through Day 5

Secondary Outcomes (4)

• MoCA

  Through study completion, typically occurring at hospital discharge or within 10 days of hospital discharge

• Hospital Anxiety and Depression Survey (HADS)

  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.

• IES-R

  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.

• EQ5D

  Through study completion, typically occurring at hospital discharge or within 10 days of hospital discharge

Study Arms (1)

VR-PARTNER

Participants in ICU

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the intensive care unit at University of Kentucky with sepsis or acute respiratory failure.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirby Mayer: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kirby P. Mayer, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louisa A Summers, Ph.D.

CONTACT

859-200-6008; lasu229@uky.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 14, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

US (1)