Active vs. Passive VR During Office-based ENT Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual reality headset or goggles.
- Who it may be relevant to
- Registry conditions: Pain, Anxiety, Chronic Rhinosinusitis (CRS), Nasal Obstruction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Active vs. Passive Virtual Reality for Reducing Pain and Anxiety During Office-based ENT Procedures
Overview
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.
Interventions
- 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
Primary outcome measures
- Pain assessed with visual analog scale [Time frame: 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]
Secondary outcome measures (1)
- Clinician experience with VR use [Time frame: Immediately after the office-based ENT procedure during a single study visit]
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 (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."
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cedars Sinai Medical Offices East Tower — Los Angeles
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 34152420
Identifiers
NCT: NCT07599826 · STUDY00004672