Acute Respiratory FailureVR-PARTNERNCT06876168
Virtual Reality in ICU - PARTNER
An observational study of Acute Respiratory Failure and Sepsis, run by Kirby Mayer at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Respiratory Failure, Sepsis
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2025to 15 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the intensive care unit at University of Kentucky with sepsis or acute respiratory failure.
Who may be able to join
- Admitted to ICU at University of Kentucky for acute respiratory failure, sepsis or other
Who cannot join
- 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
Show all 9Show fewer
- Are a prisoner
- Receiving hospice care
- Have existing open wounds or pressure ulcers on head or neck
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Acute Respiratory Failure, Sepsis
- Keywords
- virtual reality, intensive care unit, sepsis, acute respiratory failure
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VR-PARTNER | Participants in ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale
System Usability Scale - describing the ease of use of the procedure and device
Measured: 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.
Measured: From enrollment to the end of treatment (5 sessions); Day 1 through Day 5
Secondary outcomes (4)
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.
Measured: Through study completion, typically occurring at hospital discharge or within 10 days of hospital discharge
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).
Measured: 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
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.
Measured: 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
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).
Measured: Through study completion, typically occurring at hospital discharge or within 10 days of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start2 Jul 2025
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Mayer
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor-investigator, Kirby Mayer, University of Kentucky
- Investigators
- Kirby P. Mayer, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876168
- Sponsor's protocol ID
- 97957
- Other IDs
- R43AT013038
- Acronym
- VR-PARTNER
- Status last verified
- Jul 2026
- First submitted
- 24 Feb 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06876168
- Acronym / sponsor ID
- VR-PARTNER / 97957
- Conditions
- Acute Respiratory Failure, Sepsis
- Keywords
- virtual reality, intensive care unit, sepsis, acute respiratory failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kirby MayerUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR-PARTNER | – | –Participants in ICU |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the intensive care unit at University of Kentucky with sepsis or acute respiratory failure.
Key inclusion criteria (1 listed)
- Admitted to ICU at University of Kentucky for acute respiratory failure, sepsis or other
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
System Usability Scale
Time frame: 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
Time frame: 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.
4 secondary outcomes
MoCA
Time frame: Through study completion, typically occurring at hospital discharge or within 10 days of hospital discharge
Hospital Anxiety and Depression Survey (HADS)
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.
IES-R
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.
EQ5D
Time frame: Through study completion, typically occurring at hospital discharge or within 10 days of hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided. Not decided yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirby P. Mayer, Ph.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Sepsis, run by Kirby Mayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: From enrollment to end of treatment (5 sessions); Day 1 through Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.