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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Mobility; Heart Surgery; ICU; Nursing
• Intervention / Treatment: Behavioral: VR assisted mobility

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Virtual Reality (VR) intervention; Cohort for observing the effects of the VR intervention on ICU mobility.	Behavioral: VR assisted mobility; Commercially-based VR experience used to help move upper extremities to music, similar to dancing or Tai-Chi.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as measured by nursing time required	For each participant, the total nursing time spent (in minutes) setting up and delivering the intervention will be recorded.	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability as measured by patient-reported ease of playing the game	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.	up to 6 months
Usability as measured by patient-reported ease of hand controller use	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.	up to 6 months
Usability as measured by patient-reported wearability of headset	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.	up to 6 months
Usability as measured by patient-reported comfort of headset	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.	up to 6 months
Number of participants who find the intervention acceptable	Acceptability: Participants will be asked if they would recommend this game to a friend or loved one, yes or no.	up to 6 months
Change in mobility activity frequency	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.	Baseline, 6 months
Change in mobility activity time	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.	Baseline, 6 months
Change in Hospital Anxiety and Depression Scale (HADS) - anxiety	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.	Baseline to day 10 or ICU transfer, whichever comes first
Change in Hospital Anxiety and Depression Scale (HADS) - depression	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.	Baseline to day 10 or ICU transfer, whichever comes first
Change in UCLA 3-item Loneliness Scale	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.	Baseline to day 10 or ICU transfer, whichever comes first

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BDNF (brain-derived neurotrophic factor) level	BDNF may play a role in the biology of mood disorders.	Baseline to day 10 or ICU transfer, whichever comes first
Change in TNF (tumor necrosis factor) level	TNF is a protein that plays a role in the development of depression and other psychiatric disorders.	Baseline to day 10 or ICU transfer, whichever comes first

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Anna E Mall, MSN, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PRO00116448

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No