Virtual Reality for ICU Patients

(GAMERS Trial)

Overseen By Anna E Mall, MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Pregnancy, Blindness, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment VR assisted mobility for ICU patients?

Research suggests that virtual reality (VR) can help reduce anxiety, stress, fear, and pain in patients, and assist with mobility and rehabilitation, which may be beneficial for ICU patients. However, most studies provide only a low level of evidence, and there are challenges in integrating VR into routine ICU care. ^{1 2 3 4 5}

Is virtual reality safe for ICU patients?

Virtual reality (VR) has been used in ICU settings and is generally well accepted by patients, with low discomfort reported. Some users may experience 'cybersickness' (unwanted side effects like dizziness or nausea), but studies show VR can have relaxing effects, such as reducing respiratory rates, and is considered safe for use in critically ill patients. ^{1 3 6 7 8}

How is the VR assisted mobility treatment different from other treatments for ICU patients?

The VR assisted mobility treatment is unique because it uses virtual reality to help ICU patients start moving earlier, combining exercise with cognitive training and visualizing the process to aid rehabilitation. This approach is different from traditional methods as it immerses patients in a virtual environment, potentially reducing anxiety and improving engagement in their recovery. ^{1 4 8 9 10}

Research Team

Anna E Mall, MSN

Principal Investigator

Duke University

Eligibility Criteria

This trial is for patients in the cardiothoracic ICU who are able to participate in activities that involve upper body movement. They should be willing to use a VR device and play games designed to encourage mobility, as well as complete surveys about their mental health.

Inclusion Criteria

I was in the ICU for 3 or more days and couldn't move much.

English speaking

I am 18 years old or older.

Exclusion Criteria

I have had seizures in the past.

Pregnancy

History of special enteric contact isolation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a Virtual Reality intervention to improve mobility and psychological health in the ICU

up to 6 months

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• VR assisted mobility

Trial Overview The study is testing whether using Virtual Reality (VR) applications can help improve physical activity and psychological well-being of patients recovering in the intensive care unit after cardiac surgery.

Participant Groups

Group I: Virtual Reality (VR) intervention Experimental Treatment 1 Intervention

Cohort for observing the effects of the VR intervention on ICU mobility.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

Virtual reality (VR) has the potential to reduce anxiety, stress, and pain in critically ill patients, while also aiding in their rehabilitation and improving communication among care providers.

Augmented reality (AR) can enhance the education of healthcare providers in critical care settings, helping them acquire essential skills, but both technologies face challenges such as 'cybersickness' and ethical concerns regarding their use in vulnerable patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual and augmented reality in critical care medicine: the patient's, clinician's, and researcher's perspective. Bruno, RR., Wolff, G., Wernly, B., et al.[2022]

The study demonstrated that immersive virtual reality (iVR) is feasible for use in critically ill patients in the ICU, including those on mechanical ventilation, with 80% of sessions completed without serious side effects.

iVR significantly reduced anxiety levels in patients after each session, indicating that digital therapies like iVR can effectively improve emotional well-being during ICU stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usage of immersive virtual reality as a relaxation method in an intensive care unit. Martí-Hereu, L., Navarra-Ventura, G., Navas-Pérez, AM., et al.[2023]

A pilot study in the PICU involving children aged 3 to 17 showed that 100% of participants enjoyed using virtual reality, indicating high satisfaction with this intervention.

Parents reported that 82% of children felt calmer after using virtual reality, suggesting it may be an effective tool for improving emotional well-being in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Innovative Virtual Reality Experience in the PICU: A Pilot Study. Badke, CM., Essner, BS., O'Connell, M., et al.[2020]

A systematic review of 59 studies highlights that virtual reality (VR) and augmented reality (AR) can enhance training for healthcare providers in intensive care units (ICUs) by simulating complex procedures like CPR and intubation.

VR and AR technologies may also benefit patients in ICUs by reducing stress and pain during invasive procedures, facilitating communication with relatives, and supporting rehabilitation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual and augmented reality in intensive care medicine: a systematic review. Kanschik, D., Bruno, RR., Wolff, G., et al.[2023]

The Visual Patient Avatar ICU technology enhances patient monitoring by dynamically displaying vital signs and device information, which ICU professionals found to improve information retention and problem identification.

While most users had a positive perception of the tool's simplicity and intuitiveness, some expressed concerns about potential information overload and the lack of exact numerical values, indicating areas for further development before clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User Perceptions of Avatar-Based Patient Monitoring for Intensive Care Units: An International Exploratory Sequential Mixed-Methods Study. Lunkiewicz, J., Gasciauskaite, G., Roche, TR., et al.[2023]

A study involving 33 critically ill cardiac surgery patients showed that using virtual reality (VR) technology during their ICU stay significantly decreased their respiratory rate, indicating a relaxing effect, while heart rate and blood pressure remained stable.

Patients reported high acceptance and recollection of the VR experience, with 84.8% recalling the VR sessions compared to only 30.3% recalling their ICU stay, suggesting that VR can provide effective cognitive stimulation and comfort during critical illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perception and Performance on a Virtual Reality Cognitive Stimulation for Use in the Intensive Care Unit: A Non-randomized Trial in Critically Ill Patients. Gerber, SM., Jeitziner, MM., Knobel, SEJ., et al.[2020]

In a pilot study involving 12 critically ill children in a Pediatric Critical Care Unit, virtual reality exercise using Nintendo Wii™ Boxing was found to be safe, with no adverse events reported during the intervention.

While the VR exercise increased upper limb activity compared to daily activity, challenges in feasibility were noted, as only 8 participants completed the study, indicating potential barriers to implementation in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Wii-Hab" in critically ill children: a pilot trial. Abdulsatar, F., Walker, RG., Timmons, BW., et al.[2022]

A proof-of-concept study involving 37 healthy participants in an ICU showed that virtual reality (VR) stimulation with natural scene videos significantly reduced heart rate and blood pressure, indicating a calming effect.

The VR setup also improved visual processing, as evidenced by an increased fixation/saccade ratio, suggesting that VR can enhance cognitive engagement and potentially aid in recovery for critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visuo-acoustic stimulation that helps you to relax: A virtual reality setup for patients in the intensive care unit. Gerber, SM., Jeitziner, MM., Wyss, P., et al.[2019]

A multidisciplinary team has created a virtual reality system designed to promote early mobilization for critically ill patients in the ICU, addressing the low utilization rates of such practices.

The system includes features like varied mobilization exercises, cognitive training integration, visualization of exercises, and tracking of progress, which may enhance patient rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Virtual Reality System for Early Mobilization of Critically Ill Patients. Wang, J., Zhang, C., Jia, Y., et al.[2019]

A survey of 233 clinicians and 50 patients at Mayo Clinic revealed that both groups generally support the use of video recognition (VR) technology in the ICU, particularly for enhancing patient safety and aiding in diagnostics.

Concerns about VR include potential privacy breaches and the impact on the patient-clinician relationship, with 81% of clinicians worried about VR being used in lawsuits and 59% of patients expressing privacy concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are We Ready for Video Recognition and Computer Vision in the Intensive Care Unit? A Survey. Glancova, A., Do, QT., Sanghavi, DK., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Virtual and augmented reality in critical care medicine: the patient's, clinician's, and researcher's perspective. [2022]

2. Spain pubmed.ncbi.nlm.nih.gov

Usage of immersive virtual reality as a relaxation method in an intensive care unit. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

An Innovative Virtual Reality Experience in the PICU: A Pilot Study. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Virtual and augmented reality in intensive care medicine: a systematic review. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

User Perceptions of Avatar-Based Patient Monitoring for Intensive Care Units: An International Exploratory Sequential Mixed-Methods Study. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Perception and Performance on a Virtual Reality Cognitive Stimulation for Use in the Intensive Care Unit: A Non-randomized Trial in Critically Ill Patients. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

"Wii-Hab" in critically ill children: a pilot trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Visuo-acoustic stimulation that helps you to relax: A virtual reality setup for patients in the intensive care unit. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a Virtual Reality System for Early Mobilization of Critically Ill Patients. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Are We Ready for Video Recognition and Computer Vision in the Intensive Care Unit? A Survey. [2022]