Virtual Reality for Intensive Care Unit Delirium

Overseen By Devon S Callahan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Severe motion sickness, Seizure, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) can help prevent delirium in patients in the surgical intensive care unit (ICU). Participants will receive either standard ICU care or standard care plus a daily 15-minute VR session featuring calming scenes, meditation, and music. The goal is to determine if these VR sessions can reduce the occurrence and duration of delirium and potentially shorten hospital stays. The study seeks adult surgical ICU patients at Cedars-Sinai who are not experiencing delirium at the start and have at least one risk factor, such as recent major surgery or a history of cognitive impairment. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance ICU care.

Do I have to stop taking my current medications for this trial?

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

What prior data suggests that this virtual reality intervention is safe for ICU patients?

Research has shown that using virtual reality (VR) in medical settings is generally safe and well-tolerated. Studies have found that VR can effectively help prevent confusion in ICU patients without causing serious side effects. For example, a review of VR use in ICUs revealed that patients often felt calmer and experienced better mental health outcomes without any major negative incidents.

If side effects occur, they are usually mild, such as slight dizziness or discomfort, and they tend to resolve quickly. Overall, VR is considered a non-invasive and low-risk option, especially compared to other medical treatments. This makes it a promising tool for reducing the risk of confusion in the ICU. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for ICU delirium because it offers a non-invasive, immersive experience that can engage patients' senses and potentially reduce their confusion and anxiety. Unlike standard treatments for ICU delirium, which often involve medications like antipsychotics or sedatives, VR is drug-free and minimizes the risk of medication side effects. Additionally, VR has the potential to transport patients to calming environments, which might help in stabilizing their mental state more quickly and comfortably than traditional methods.

What evidence suggests that virtual reality is effective for reducing ICU delirium?

Research has shown that virtual reality (VR) can reduce confusion and disorientation, known as delirium, in intensive care unit (ICU) patients. In this trial, some participants will receive standard ICU delirium prevention, while others will receive the study ICU delirium prevention along with VR treatment. Previous studies found that patients using VR experienced more delirium-free days over two weeks. They also slept better, which is important for preventing delirium. VR often includes calming scenes and guided meditation to help relax patients. This drug-free method shows promise in supporting ICU patients at risk of delirium. ^{4 6 7 8 9}

Who Is on the Research Team?

Devon S Callahan, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for adult surgical ICU patients at Cedars-Sinai who are currently not experiencing delirium and have at least one risk factor for developing it. They must be able to participate in daily 15-minute VR sessions. Patients with conditions that prevent them from using VR or those already showing signs of delirium cannot join.

Inclusion Criteria

Individuals who are currently admitted to the SICU at Cedars-Sinai Medical Center

Expected ICU stay >48 hours

Richmond Agitation Sedation Scale (RASS) score between -1 to +2

Exclusion Criteria

End-of-life care

I am willing and able to participate in the study.

Intubation of tracheostomy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive standard ICU care or standard care plus once-daily 15-minute VR sessions

5 days

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

Until ICU discharge, up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview

The study is testing if virtual reality therapeutics can help prevent delirium in the ICU. Participants will either receive standard care or standard care plus a daily dose of calming VR content, including natural scenes and guided meditation.

How Is the Trial Designed?

Group I: Study ICU Delirium Prevention and VR treatment Experimental Treatment 1 Intervention

Group II: Standard ICU delirium prevention Active Control 1 Intervention

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39819916/

Effectiveness of a virtual reality-based sensory stimulation ...

We define delirium-free days over a 14-day period as the primary outcome. The secondary outcomes will include delirium incidence, duration and ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0964339725003805

Effectiveness of virtual reality interventions for delirium ...

This systematic review aimed to evaluate the effectiveness of virtual reality (VR) interventions for delirium prevention in adult intensive care units (ICU) ...

3.

ajpmonline.org

ajpmonline.org/article/S0749-3797(25)00398-8/fulltext

The Impact of Virtual Reality Technology on Delirium ...

In terms of sleep quality, patients demonstrated significant improvements in PSQI scores post-intervention (P<0.01), reflecting the effectiveness of virtual ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06153472

Effectiveness of a Virtual Reality-Based Sensory ...

The goal of this clinical trial is to evaluate the effectiveness of a VR-based sensory stimulation system in preventing ICU delirium in patients. The main ...

5.

bmjopen.bmj.com

bmjopen.bmj.com/content/15/1/e083966

Effectiveness of a virtual reality-based sensory stimulation ...

This study aims to evaluate the effects of a VR-based sensory stimulation in preventing delirium, and improving patients' psychological (post-traumatic stress ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07357389

NCT07357389 | Virtual Reality for ICU Delirium Prevention

Participants will be randomized to either standard ICU care or standard care plus once-daily 15-minute VR sessions consisting of calming natural ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12321352/

Effects of Virtual Reality Meditation on Sleep and Delirium in ...

The purpose of this study was to evaluate the effectiveness of virtual reality meditation compared with standard care on sleep quality and delirium ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0964339725003805?dgcid=rss_sd_all

Effectiveness of virtual reality interventions for delirium ...

This systematic review aimed to evaluate the effectiveness of virtual reality (VR) interventions for delirium prevention in adult intensive care units (ICU) ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12679386/

Virtual reality for delirium prevention in mechanically ... - PMC

To explore the advantages, applications and shortcomings of virtual reality technology in the prevention of delirium in ICU patients with ...