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Active, Not Recruiting

NCT Number: NCT06797895

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Mobility Heart Surgery ICU Nursing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR assisted mobility

Behavioral

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

Primary outcomes

  1. Feasibility as measured by nursing time required

    Time frame: up to 6 months

    For each participant, the total nursing time spent (in minutes) setting up and delivering the intervention will be recorded.

Secondary outcomes

  1. Usability as measured by patient-reported ease of playing the game

    Time frame: up to 6 months

    Usability: 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.

  2. Usability as measured by patient-reported ease of hand controller use

    Time frame: up to 6 months

    Usability: 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.

  3. Usability as measured by patient-reported wearability of headset

    Time frame: up to 6 months

    Usability: 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.

  4. Usability as measured by patient-reported comfort of headset

    Time frame: up to 6 months

    Usability: 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.

  5. Number of participants who find the intervention acceptable

    Time frame: up to 6 months

    Acceptability: Participants will be asked if they would recommend this game to a friend or loved one, yes or no.

  6. Change in mobility activity frequency

    Time frame: Baseline, 6 months

    To 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.

  7. Change in mobility activity time

    Time frame: Baseline, 6 months

    To 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.

  8. Change in Hospital Anxiety and Depression Scale (HADS) - anxiety

    Time frame: Baseline to day 10 or ICU transfer, whichever comes first

    The 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.

  9. Change in Hospital Anxiety and Depression Scale (HADS) - depression

    Time frame: Baseline to day 10 or ICU transfer, whichever comes first

    The 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.

  10. Change in UCLA 3-item Loneliness Scale

    Time frame: Baseline to day 10 or ICU transfer, whichever comes first

    This 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.

Other outcomes

  1. Change in BDNF (brain-derived neurotrophic factor) level

    Time frame: Baseline to day 10 or ICU transfer, whichever comes first

    BDNF may play a role in the biology of mood disorders.

  2. Change in TNF (tumor necrosis factor) level

    Time frame: Baseline to day 10 or ICU transfer, whichever comes first

    TNF is a protein that plays a role in the development of depression and other psychiatric disorders.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: GAMERS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2025
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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