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PainNCT07599826

Active vs. Passive VR During Office-based ENT Procedures

A study testing Passive virtual reality headset or goggles and Active virtual reality headset or goggles in people with Pain and Anxiety, run by Cedars-Sinai Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Anxiety, Chronic Rhinosinusitis (CRS)
What is being tested?
Passive virtual reality headset or goggles and Active virtual reality headset or goggles
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteUnited States
Study dates
Sep 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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."
  • 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."

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dennis M Tang, MD contact

310-423-1220

Dennis.Tang2@cshs.org

United States1 site

  • Cedars Sinai Medical Offices East Tower

    Los Angeles, California, 90048

    Dennis M Tang, MD, 310-423-1220, Dennis.Tang2@cshs.org

Other trials in United States

About this study

Official title: 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.

Being tested
Passive virtual reality headset or goggles, Active virtual reality headset or goggles
Medical subject headings
Pain, Anxiety Disorders, Nasal Obstruction, Nasal Polyps, Dysphonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Passive virtual reality headset or gogglesDevice

    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 gogglesDevice

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

Study groups in NCT07599826
Study groupRoleWhat they receive
Passive virtual realityExperimentalpassively watching calming scenery
Receives: Device: Passive virtual reality headset or goggles
Active virtual realityExperimentalinteractive game
Receives: Device: Active virtual reality headset or goggles

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Immediately after the office-based ENT procedure

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

    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.

    Measured: Immediately after the office-based ENT procedure

Secondary outcomes (1)

  1. Clinician Experience with Virtual Reality Use

    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.

    Measured: Immediately after the office-based ENT procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07599826
Sponsor's protocol ID
STUDY00004672
Status last verified
Aug 2026
First submitted
14 May 2026
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Tyler MA, Lam K, Ashoori F, Cai C, Kain JJ, Fakhri S, Citardi MJ, Cattano D, Luong A. Analgesic Effects of Intravenous Acetaminophen vs Placebo for Endoscopic Sinus Surgery and Postoperative Pain: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 Aug 1;143(8):788-794. doi: 10.1001/jamaoto.2017.0238.

    PubMed 28542675

  • Chang J, Ninan S, Liu K, Iloreta AM, Kirke D, Courey M. Enhancing Patient Experience in Office-Based Laryngology Procedures With Passive Virtual Reality. OTO Open. 2021 Jan 8;5(1):2473974X20975020. doi: 10.1177/2473974X20975020. eCollection 2021 Jan-Mar.

    PubMed 33474521

  • Gray ML, Goldrich DY, McKee S, Schaberg M, Del Signore A, Govindaraj S, Iloreta AM. Virtual Reality as Distraction Analgesia for Office-Based Procedures: A Randomized Crossover-Controlled Trial. Otolaryngol Head Neck Surg. 2021 Mar;164(3):580-588. doi: 10.1177/0194599820942215. Epub 2020 Aug 4.

    PubMed 32746734

  • Pandrangi VC, Shah SN, Bruening JD, Wax MK, Clayburgh D, Andersen PE, Li RJ. Effect of Virtual Reality on Pain Management and Opioid Use Among Hospitalized Patients After Head and Neck Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Aug 1;148(8):724-730. doi: 10.1001/jamaoto.2022.1121.

    PubMed 35679057

  • Moreau S, Therond A, Cerda IH, Studer K, Pan A, Tharpe J, Crowther JE, Abd-Elsayed A, Gilligan C, Tolba R, Ashina S, Schatman ME, Kaye AD, Yong RJ, Robinson CL. Virtual Reality in Acute and Chronic Pain Medicine: An Updated Review. Curr Pain Headache Rep. 2024 Sep;28(9):893-928. doi: 10.1007/s11916-024-01246-2. Epub 2024 Apr 8.

    PubMed 38587725

  • Liu KY, Ninan SJ, Laitman BM, Goldrich DY, Iloreta AM, Londino AV 3rd. Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures. Laryngoscope. 2021 May;131(5):E1714-E1721. doi: 10.1002/lary.29148. Epub 2020 Oct 5.

    PubMed 33017065

  • Gerceker GO, Salmal N, Bektas I. The effect of active and passive virtual reality distractions on phlebotomy-related emotional behavior, pain, anxiety, and fear in children: A randomized controlled trial. J Pediatr Nurs. 2025 Jul-Aug;83:190-198. doi: 10.1016/j.pedn.2025.05.005. Epub 2025 May 12.

    PubMed 40359712

  • Xiang H, Shen J, Wheeler KK, Patterson J, Lever K, Armstrong M, Shi J, Thakkar RK, Groner JI, Noffsinger D, Giles SA, Fabia RB. Efficacy of Smartphone Active and Passive Virtual Reality Distraction vs Standard Care on Burn Pain Among Pediatric Patients: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2112082. doi: 10.1001/jamanetworkopen.2021.12082.

    PubMed 34152420

  • Bani Mohammad E, Ahmad M. Virtual reality as a distraction technique for pain and anxiety among patients with breast cancer: A randomized control trial. Palliat Support Care. 2019 Feb;17(1):29-34. doi: 10.1017/S1478951518000639. Epub 2018 Sep 10.

    PubMed 30198451

  • Shetty V, Suresh LR, Hegde AM. Effect of Virtual Reality Distraction on Pain and Anxiety During Dental Treatment in 5 to 8 Year Old Children. J Clin Pediatr Dent. 2019;43(2):97-102. doi: 10.17796/1053-4625-43.2.5. Epub 2019 Feb 7.

    PubMed 30730798

Questions about this trial

What is this clinical trial studying?

A study testing Passive virtual reality headset or goggles and Active virtual reality headset or goggles in people with Pain and Anxiety, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dennis M Tang, MD (310-423-1220, Dennis.Tang2@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-Procedure Pain Assessed Using the Visual Analog Scale (time frame: Immediately after the office-based ENT procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07599826, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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