Clinical trial NCT06797895: Designing a Virtual Reality Intervention to Improve Physical and Psychological Health in Intensive Care Units
Official title: Designing a Virtual Reality Intervention to Improve Physical and Psychological Health in Intensive Care Units
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mobility
ICU
Heart Surgery
Nursing
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to explore if Virtual Reality helps patients in the cardiothoracic ICU move more and feel better. Participants will be asked to answer a survey about anxiety, depression, and loneliness. The study team will teach participants how to use the VR device and how to play the game. Participants will play the game at least once per day, but can play as much as they want. Study activities include nurse facilitated patient use of VR applications that involve upper body movement (e.g., using arms and hands to dance or hit objects in a virtual reality environment).

Detailed description: Patients who survive critical illness and prolonged intensive care unit (ICU) stays are at risk for debilitating physical (deconditioning, skin injury, and infection), and mental health impairment (depression, anxiety and PTSD). Early mobility improves these deleterious outcomes but is challenging to implement in patients on prolonged bedrest. The purpose of this study is to compare a nurse-led implementation of a Virtual Reality (VR) experience in the Cardio-Thoracic Intensive Care Unit (CT-ICU) to standard of care to improve mobility for patients on prolonged bedrest. The investigators hypothesize that nurse-led implementation of VR experiences in the CT-ICU, in combination with engineering-led patient-centered customization of the VR applications, will improve both the physical and psychological function of ICU patients on prolonged bedrest.

Eligibility criteria: Inclusion Criteria:

* Adult
* English speaking
* 3+ days ICU admission with limited mobility

Exclusion Criteria:

* Pregnancy
* Blind/severe visual impairment
* History of seizures
* Intubation/sedation
* Special enteric contact isolation

Primary outcomes:
measure: Feasibility as measured by nursing time required
timeFrame: up to 6 months
Secondary outcomes:
measure: Usability as measured by patient-reported ease of playing the game
timeFrame: up to 6 months
measure: Usability as measured by patient-reported ease of hand controller use
timeFrame: up to 6 months
measure: Usability as measured by patient-reported wearability of headset
timeFrame: up to 6 months
measure: Usability as measured by patient-reported comfort of headset
timeFrame: up to 6 months
measure: Number of participants who find the intervention acceptable
timeFrame: up to 6 months
measure: Change in mobility activity frequency
timeFrame: Baseline, 6 months
measure: Change in mobility activity time
timeFrame: Baseline, 6 months
measure: Change in Hospital Anxiety and Depression Scale (HADS) - anxiety
timeFrame: Baseline to day 10 or ICU transfer, whichever comes first
measure: Change in Hospital Anxiety and Depression Scale (HADS) - depression
timeFrame: Baseline to day 10 or ICU transfer, whichever comes first
measure: Change in UCLA 3-item Loneliness Scale
timeFrame: Baseline to day 10 or ICU transfer, whichever comes first
Other outcomes:
measure: Change in BDNF (brain-derived neurotrophic factor) level
timeFrame: Baseline to day 10 or ICU transfer, whichever comes first
measure: Change in TNF (tumor necrosis factor) level
timeFrame: Baseline to day 10 or ICU transfer, whichever comes first
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Anna E Mall, MSN
role: PRINCIPAL_INVESTIGATOR
References: