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Designing a Virtual Reality Intervention to Improve Physical and Psychological Health in Intensive Care Units

Designing a Virtual Reality Intervention to Improve Physical and Psychological Health in Intensive Care Units

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06797895
Acronym
GAMERS
Enrollment
30
Registered
2025-01-29
Start date
2024-12-04
Completion date
2026-08-01
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Surgery, ICU, Mobility, Nursing

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.

Interventions

BEHAVIORALVR assisted mobility

Commercially-based VR experience used to help move upper extremities to music, similar to dancing or Tai-Chi.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility as measured by nursing time requiredup to 6 monthsFor each participant, the total nursing time spent (in minutes) setting up and delivering the intervention will be recorded.

Secondary

MeasureTime frameDescription
Usability as measured by patient-reported ease of playing the gameup to 6 monthsUsability: Using a 5-point Likert scale (0- very difficult to 5- very easy; higher is better outcome), participants will be surveyed after the intervention period to assess ease of playing the game.
Usability as measured by patient-reported ease of hand controller useup to 6 monthsUsability: Using a 5-point Likert scale (0- very difficult to 5- very easy; higher is better outcome), participants will be surveyed after the intervention period to assess ease of hand controller use.
Usability as measured by patient-reported wearability of headsetup to 6 monthsUsability: Using a 5-point Likert scale (0- very difficult to 5- very easy; higher is better outcome), participants will be surveyed after the intervention period to assess wearability of headset.
Usability as measured by patient-reported comfort of headsetup to 6 monthsUsability: Using a 5-point Likert scale (0- very difficult to 5- very easy; higher is better outcome), participants will be surveyed after the intervention period to assess comfort of headset.
Number of participants who find the intervention acceptableup to 6 monthsAcceptability: Participants will be asked if they would recommend this game to a friend or loved one, yes or no.
Change in mobility activity frequencyBaseline, 6 monthsTo determine if a VR intervention increases mobility for patients on prolonged bedrest, the frequency of VR sessions is recorded. Frequency will be reported as counts.
Change in mobility activity timeBaseline, 6 monthsTo determine if a VR intervention increases mobility for patients on prolonged bedrest, the duration of each VR session is recorded. Activity will be reported as total minutes.
Change in Hospital Anxiety and Depression Scale (HADS) - anxietyBaseline to day 10 or ICU transfer, whichever comes firstThe Hospital Anxiety and Depression Scale (HADS) is a self-report scale used to measure the severity of depression and anxiety in patients with comorbid medical conditions. The total score for anxiety ranges from 0 to 21, where a higher score indicates greater anxiety.
Change in Hospital Anxiety and Depression Scale (HADS) - depressionBaseline to day 10 or ICU transfer, whichever comes firstThe Hospital Anxiety and Depression Scale (HADS) is a self-report scale used to measure the severity of depression and anxiety in patients with comorbid medical conditions. The total score for depression ranges from 0 to 21, where a lower score indicates greater depression.
Change in UCLA 3-item Loneliness ScaleBaseline to day 10 or ICU transfer, whichever comes firstThis scale comprises 3 questions that measure three dimensions of loneliness: relational connectedness, social connectedness and self-perceived isolation. The total score ranges from 0 to 9, where a higher score indicates greater loneliness.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAnna E Mall, MSN

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026