Active vs. Passive VR During Office-based ENT Procedures

May 14, 2026 updated by: Dennis Tang, Cedars-Sinai Medical Center

Active vs. Passive Virtual Reality for Reducing Pain and Anxiety 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 reality during office-based ENT procedures. The main procedures include exposure to virtual reality (passive calming scenery or interactive puzzle game) via Paperplane Therapeutics software with VR headset or glasses during common in-office ENT procedures, participant self-report surveys (GAD-7, PHQ-9, PEG, VAS, SUDS, Likert, experience questions), and physician post-procedure survey. The study will enroll individuals 18 years or older who are scheduled to undergo common office-based ENT procedures (turbinate reduction, nasal debridement, balloon sinuplasty, radiofrequency ablation, nasal polypectomy, eustachian tube dilation, vocal fold injection, or subglottic steroid injection) at Cedars Sinai.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Offices East Tower
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria Active and Passive VR:

  • Individuals 18 years old and older are included
  • Individuals undergoing the following common office-based ENT procedures: turbinate reduction, nasal debridement, balloon sinuplasty, radiofrequency ablation (Rhineaer/Vivaer), nasal polypectomy, eustachian tube dilation, vocal fold injection, or subglottic steroid injection
  • Able to consent
  • English speaking

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
  • Any records flagged "break the glass" or "research opt out."

Exclusion Criteria Passive VR:

  • History of neurologic or seizure disorder, developmental delay, uncorrected visual impairment, motion sickness, or vertigo
  • Any records flagged "break the glass" or "research opt out."

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Passive virtual reality
passively watching calming scenery
Device: Virtual reality headset or goggles
Exposure to virtual reality via Paperplane Therapeutics software with VR headset or glasses during common in-office ENT procedures
Experimental: Active virtual reality
interactive game
Device: Virtual reality headset or goggles
Exposure to virtual reality via Paperplane Therapeutics software with VR headset or glasses during common in-office ENT procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessed with visual analog scale
Time Frame: Immediately before and immediately after the office-based ENT procedure during a single study visit
Pain assessed on VAS (visual analog scale of 0-100 mm)
Immediately before and immediately after the office-based ENT procedure during a single study visit
Anxiety assessed with subjective units of distress scale
Time Frame: Immediately before and immediately after the office-based ENT procedure during a single study visit
Anxiety assessed using Subjective Units of Distress scale (0-100)
Immediately before and immediately after the office-based ENT procedure during a single study visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician experience with VR use
Time Frame: Immediately after the office-based ENT procedure during a single study visit
Clinician experience with VR use assessing feasability and observed patient comfort using 7-point Likert scale
Immediately after the office-based ENT procedure during a single study visit

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with VR use
Time Frame: Immediately after the office-based ENT procedure during a single study visit
Patient satisfaction with VR use will be assessed using 7-point Likert scale for satisfaction and 5 brief multiple-choice experience questions
Immediately after the office-based ENT procedure during a single study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 14, 2026

First Submitted That Met QC Criteria

May 14, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004672

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

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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