Active vs. Passive VR During Office-based ENT Procedures

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Virtual reality headset or goggles
  Exposure to virtual reality via Paperplane Therapeutics software with VR headset or glasses during common in-office ENT procedures

Первичные конечные точки

• Pain assessed with visual analog scale [Срок оценки: Immediately before and immediately after the office-based ENT procedure during a single study visit]
• Anxiety assessed with subjective units of distress scale [Срок оценки: Immediately before and immediately after the office-based ENT procedure during a single study visit]

Вторичные конечные точки (1)

• Clinician experience with VR use [Срок оценки: Immediately after the office-based ENT procedure during a single study visit]

Критерии участия

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."

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Cedars Sinai Medical Offices East Tower — Los Angeles

Публикации

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• 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

Идентификаторы

NCT: NCT07599826 · STUDY00004672

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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