[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07599826":3,"trial-entities:NCT07599826":127,"trial-summary:NCT07599826":134},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":27,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":47,"secondary_outcomes":55,"sex":59,"minimum_age":60,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":61,"std_ages":72,"locations":75,"central_contacts":91,"overall_officials":93,"references":94,"see_also_links":126},"NCT07599826","STUDY00004672","Active vs. Passive VR During Office-based ENT Procedures","Active vs. Passive Virtual Reality for Reducing Pain and Anxiety During Office-based ENT Procedures","NOT_YET_RECRUITING","2027-12","2026-08","2026-08-17","2026-09","Cedars-Sinai Medical Center","OTHER",false,"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.",null,[19,20,21,22,23,24,25,26],"Pain","Anxiety","Chronic Rhinosinusitis (CRS)","Nasal Obstruction","Nasal Polyp","Eustachian Tube Dysfunction","Dysphonia","Subglottic Stenosis (SGS)",[],"INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},132,"ESTIMATED",[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DEVICE","Passive 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",[41],"Passive virtual reality",{"type":37,"name":43,"description":44,"armGroupLabels":45},"Active 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.",[46],"Active virtual reality",[48,52],{"measure":49,"description":50,"timeFrame":51},"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.","Immediately after the office-based ENT procedure",{"measure":53,"description":54,"timeFrame":51},"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\u002Ffear\u002Fanxiety\u002Fdiscomfort that you have ever felt.\" Higher scores indicate greater distress.",[56],{"measure":57,"description":58,"timeFrame":51},"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.","ALL","18 Years",{"inclusion":62,"exclusion":67,"raw_text":71},[63,64,65,66],"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\u002FVivAer), nasal polypectomy, eustachian tube dilation, vocal fold injection, or subglottic steroid injection","Able to consent","English speaking",[68,69,70,69],"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","Inclusion Criteria Active and Passive VR:\n\n* Individuals 18 years old and older are included\n* Individuals undergoing the following common office-based ENT procedures: turbinate reduction, nasal debridement, balloon sinuplasty, radiofrequency ablation (RhinAer\u002FVivAer), nasal polypectomy, eustachian tube dilation, vocal fold injection, or subglottic steroid injection\n* Able to consent\n* English speaking\n\nExclusion Criteria Active VR:\n\n* History of neurologic or seizure disorder, developmental delay, uncorrected visual impairment, motion sickness, vertigo, or inability to use a handheld controller\n* Any records flagged \"break the glass\" or \"research opt out.\"\n\nExclusion Criteria Passive VR:\n\n* History of neurologic or seizure disorder, developmental delay, uncorrected visual impairment, motion sickness, or vertigo\n* Any records flagged \"break the glass\" or \"research opt out.\"",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":77,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":88},"Cedars Sinai Medical Offices East Tower","Los Angeles","California","90048","United States",[83],{"name":84,"role":85,"phone":86,"email":87},"Dennis M Tang, MD","CONTACT","310-423-1220","Dennis.Tang2@cshs.org",{"lat":89,"lon":90},34.05223,-118.24368,[92],{"name":84,"role":85,"phone":86,"email":87},[],[95,99,102,105,108,111,114,117,120,123],{"pmid":96,"type":97,"citation":98},"28542675","BACKGROUND","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\u002Fjamaoto.2017.0238.",{"pmid":100,"type":97,"citation":101},"33474521","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\u002F2473974X20975020. eCollection 2021 Jan-Mar.",{"pmid":103,"type":97,"citation":104},"32746734","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\u002F0194599820942215. Epub 2020 Aug 4.",{"pmid":106,"type":97,"citation":107},"35679057","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\u002Fjamaoto.2022.1121.",{"pmid":109,"type":97,"citation":110},"38587725","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\u002Fs11916-024-01246-2. Epub 2024 Apr 8.",{"pmid":112,"type":97,"citation":113},"33017065","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\u002Flary.29148. Epub 2020 Oct 5.",{"pmid":115,"type":97,"citation":116},"40359712","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\u002Fj.pedn.2025.05.005. Epub 2025 May 12.",{"pmid":118,"type":97,"citation":119},"34152420","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\u002Fjamanetworkopen.2021.12082.",{"pmid":121,"type":97,"citation":122},"30198451","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\u002FS1478951518000639. Epub 2018 Sep 10.",{"pmid":124,"type":97,"citation":125},"30730798","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\u002F1053-4625-43.2.5. Epub 2019 Feb 7.",[],{"nct_id":4,"conditions":128,"biomarkers":133},[129,130,25,131,22,132],"Chronic Sinusitis","Dysfunction of eustachian tube","Nasal Cavity Polyp","Subglottic stenosis",[],{"nct_id":4,"found":135,"summary":136,"prompt_version":146},true,{"design":137,"status":138,"heading":139,"summary":140,"follow_up":141,"word_count":142,"commitments":143,"compensation":144,"drugs_mentioned":145},"This interventional study plans to enroll 132 participants to compare active and passive virtual reality during ENT procedures.","completed","Virtual Reality for Pain and Anxiety During ENT Procedures","This study is looking at whether using virtual reality (VR) can help reduce pain and anxiety during common ear, nose, and throat (ENT) office procedures. Researchers want to see if \"active\" VR (like an interactive game) works better than \"passive\" VR (like calming scenery). You might be able to join if you are 18 or older and are having certain ENT procedures, such as turbinate reduction or nasal polypectomy. The study will measure your pain and anxiety levels right before and right after your procedure. The current status of this study is unclear, and it plans to enroll 132 people.","Your pain and anxiety will be assessed immediately before and immediately after the procedure during a single study visit.",100,"You would experience virtual reality through a headset during your ENT procedure and complete self-report surveys before and after the procedure.","Not stated in the trial record.",[],"v2"]