About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Passive virtual reality headset or goggles
DeviceExposure 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 goggles
DeviceExposure to interactive game through virtual reality using Paperplane Therapeutics software with a VR headset or glasses during common in-office ENT procedures.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
Other outcomes
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.
Sponsors and contacts
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