Active VR for Anxiety During ENT Procedures

DM
Overseen ByDennis M Tang, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cedars-Sinai Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether active virtual reality, such as an interactive puzzle game, reduces pain and anxiety more effectively than passive virtual reality, like watching calming scenery, during ENT (ear, nose, and throat) procedures. Participants will wear a virtual reality headset or goggles during common ENT procedures, such as nasal polypectomy or balloon sinuplasty. Individuals aged 18 or older who are scheduled for these procedures at Cedars Sinai may be suitable candidates. The goal is to determine which type of virtual reality experience makes these procedures more comfortable. As an unphased trial, this study provides a unique opportunity to explore innovative methods to enhance patient comfort during medical procedures.

What prior data suggests that this virtual reality method is safe for ENT procedures?

Past studies have shown that virtual reality (VR) is safe for patients. Research indicates that active virtual reality can greatly reduce anxiety. One study measured anxiety with a number scale and found that participants using VR felt significantly less anxious. This demonstrates that VR is not only safe but also effective at calming nerves. Similarly, passive virtual reality has proven safe. Negative effects are rare, and very few participants leave studies due to adverse experiences. This suggests that both active and passive VR are well-tolerated by patients and can help reduce anxiety during medical procedures.12345

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for managing anxiety during ENT procedures because it offers a non-invasive and engaging way to distract patients. Unlike traditional anxiety treatments such as medication or therapy, VR can instantly immerse patients in calming environments or interactive games, potentially reducing anxiety without side effects. The interactive element of active VR, where patients engage with a game, could provide an even greater level of distraction and stress relief compared to passive VR, where patients simply watch calming scenery. This innovative approach could make ENT procedures less stressful and more comfortable for patients.

What evidence suggests that active virtual reality is effective for reducing anxiety during ENT procedures?

Research has shown that virtual reality (VR) can help reduce anxiety and pain. In this trial, participants will experience different VR scenarios. Studies have found that active VR, which involves interaction with the experience, can lower anxiety and improve pain management during medical procedures. Specifically, one study found that people using active VR felt less anxious initially and managed pain more effectively. Passive VR, which involves watching calming scenes, also helps with anxiety and pain, though it might not be as effective as active VR. Overall, both active and passive VR have been shown to enhance patient comfort by reducing anxiety and pain during procedures.26789

Are You a Good Fit for This Trial?

This trial is for adults 18 or older who are scheduled to have common office-based ENT procedures, such as nasal or sinus treatments, at Cedars Sinai. Participants should not have conditions that would prevent them from using a VR headset.

Inclusion Criteria

English speaking
I am 18 years old or older.
Able to consent
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Exclusion Criteria

Active VR: History of neurologic or seizure disorder, developmental delay, uncorrected visual impairment, motion sickness, vertigo, or inability to use a handheld controller
Active VR: Any records flagged 'break the glass' or 'research opt out'
Passive VR: History of neurologic or seizure disorder, developmental delay, uncorrected visual impairment, motion sickness, or vertigo
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo office-based ENT procedures with either active or passive virtual reality exposure

Single visit
1 visit (in-person)

Follow-up

Participants are monitored for pain and anxiety immediately before and after the procedure

Immediate
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Virtual reality headset or goggles

Trial Overview

The study compares two types of virtual reality experiences—active (interactive games) versus passive (calming scenery)—to see which better reduces pain and anxiety during ENT procedures. Participants use a VR headset during their procedure.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Passive virtual realityExperimental Treatment1 Intervention
Group II: Active virtual realityExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials
523
Recruited
165,000+

Citations

Effectiveness of Virtual Reality in Reducing Perceived Pain ...

Results: The study is already underway, and results support a decrease in perceived pain by 1.00 and a decrease in perceived anxiety by 0.3 ...

Use of Virtual Reality to Reduce Anxiety and Pain of Adults ...

(1) Background: Research has demonstrated that virtual reality (VR) has reduced pain and anxiety for patients undergoing health procedures.

Effectiveness of Virtual Reality Interventions for Perioperative ...

Overall, the majority of studies demonstrated that VR effectively reduced anxiety and increased patient satisfaction. The meta‐analysis revealed a small, non‐ ...

Active vs. Passive VR During Office-based ENT Procedures

The purpose of this research is to evaluate whether active virtual reality reduces pain and anxiety more effectively than passive virtual ...

The Efficacy of Active vs Passive Virtual Reality ...

Patients who partook in active virtual reality interventions saw increases in heat pain threshold and decreases in initial anxiety and ...

Virtual Reality Is Safe and Can Reduce In‐Hospital Anxiety ...

VR significantly reduced anxiety measured by the Numeric Rating Scale (p < 0.0001) and the State–Trait Anxiety Inventory (p = 0.008).

Analgesic and Anxiolytic Effects of Virtual Reality During ...

Distraction by viewing a 3D virtual world in a head-mounted VR display did not result in lower average levels of procedural pain and anxiety than that by 2D ...

Management of Preoperative Anxiety via Virtual Reality ...

Among the 29 studies reviewed, 25 (86%) demonstrated statistically significant reductions in preoperative anxiety levels following the implementation of VR ...

Virtual reality: Treating pain and anxiety

Research indicates that Virtual Reality can provide decreases in perceived pain intensity, anxiety, and time spent thinking about pain.