ClinicalTrials.gg
Not yet recruitingNCT07599826Updated Aug 17, 2026

Active vs. Passive VR During Office-based ENT Procedures

An interventional study of Passive virtual reality headset or goggles and Active virtual reality headset or goggles in Pain, Anxiety and Chronic Rhinosinusitis (CRS), sponsored by Cedars-Sinai Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Pain
  • Anxiety
  • Chronic Rhinosinusitis (CRS)
  • Nasal Obstruction
  • Nasal Polyp
  • Eustachian Tube Dysfunction
  • Dysphonia
  • Subglottic Stenosis (SGS)
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 132 is above the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 456 studies on the registry; 107 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 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."
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
132 participants (estimated)

Study arms

  • Experimental
    Passive virtual reality

    passively watching calming scenery

    Device: Passive virtual reality headset or goggles

  • Experimental
    Active virtual reality

    interactive game

    Device: Active virtual reality headset or goggles

Interventions

  • DevicePassive virtual reality headset or goggles

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

  • DeviceActive virtual reality headset or goggles

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: Immediately after the office-based ENT procedure

Secondary outcomes

  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.

    Time frame: Immediately after the office-based ENT procedure

Other outcomes

  1. Patient Satisfaction with Virtual Reality Use

    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.

    Time frame: Immediately after the office-based ENT procedure

07

Study locations

1 site
  • Cedars Sinai Medical Offices East Tower
    Los Angeles, California 90048, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 9 months is close to that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
May 14, 2026
First posted
May 20, 2026
StartEst.
Sep 2026
Primary completionEst.
Jun 2027
CompletionEst.
Dec 2027
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07599826
Responsible party
Dennis Tang (Physician ENT, Cedars-Sinai Medical Center) — Principal investigator
First posted
May 20, 2026
Start date
Sep 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 17, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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