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NCT Number: NCT07599826

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 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.

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Key information

Conditions

Pain Airway Obstruction Anxiety Anxiety Disorders Chronic Rhinosinusitis (CRS) Dysphonia Eustachian Tube Dysfunction Laryngeal Diseases Mental Disorders Nasal Obstruction Nasal Polyp Nasal Polyps Nervous System Diseases Neurologic Manifestations Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Subglottic Stenosis (SGS) Voice Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Offices East Tower

Los Angeles, California, 90048, United States

Location contact

Dennis M Tang, MD

CONTACT

[email protected]

310-423-1220

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (RhinAer/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."

Treatment and study plan

Passive virtual reality headset or goggles

Device

Exposure to calming scenery through passive virtual reality using Paperplane Therapeutics software with VR headset or glasses during common in-office ENT procedures

Active virtual reality headset or goggles

Device

Exposure to interactive game through virtual reality using Paperplane Therapeutics software with a VR headset or glasses during common in-office ENT procedures.

Primary outcomes

  1. Post-Procedure Pain Assessed Using the Visual Analog Scale

    Time frame: Immediately after the office-based ENT procedure

    Post-procedure pain will be assessed using the Visual Analog Scale, ranging from 0 to 100 mm, where 0 mm indicates "no pain" and 100 mm indicates "worst imaginable pain." Higher scores indicate greater pain.

  2. Post-Procedure Anxiety Assessed Using the Subjective Units of Distress Scale

    Time frame: Immediately after the office-based ENT procedure

    Post-procedure anxiety will be assessed using the Subjective Units of Distress Scale, ranging from 0 to 100, where 0 indicates "totally relaxed" and 100 indicates "highest distress/fear/anxiety/discomfort that you have ever felt." Higher scores indicate greater distress.

Secondary outcomes

  1. Clinician Experience with Virtual Reality Use

    Time frame: Immediately after the office-based ENT procedure

    Clinician experience with virtual reality use will be assessed using seven physician-reported items rated on a 5-point Likert agreement scale ranging from 1 (strongly disagree) to 5 (strongly agree). Two composite scores will be derived: Feasibility (items 1-4) and Observed Patient Comfort (items 5-7). Selected items will be reverse-coded so that higher composite scores indicate more favorable clinician ratings of virtual reality feasibility and observed patient comfort.

Other outcomes

  1. Patient Satisfaction with Virtual Reality Use

    Time frame: Immediately after the office-based ENT procedure

    Patient satisfaction with virtual reality use will be assessed using a 7-point Likert scale ranging from 1 (extremely dissatisfied) to 7 (extremely satisfied). Higher scores indicate greater satisfaction. Five additional brief multiple-choice questions will assess participants' experience with virtual reality.

Study contacts

Contact information is provided by the study sponsor or research team.

Dennis M Tang, MD

CONTACT

[email protected]

310-423-1220

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Active vs. Passive Virtual Reality for Reducing Pain and Anxiety During Office-based ENT Procedures

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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