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 (Rhineaer/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
Virtual reality headset or goggles
DeviceExposure to virtual reality via Paperplane Therapeutics software with VR headset or glasses during common in-office ENT procedures
Treatment groups
Trial outcomes
Primary outcomes
Pain assessed with visual analog scale
Pain assessed on VAS (visual analog scale of 0-100 mm)
Anxiety assessed with subjective units of distress scale
Anxiety assessed using Subjective Units of Distress scale (0-100)
Secondary outcomes
Clinician experience with VR use
Clinician experience with VR use assessing feasability and observed patient comfort using 7-point Likert scale
Other outcomes
Patient satisfaction with VR use
Patient satisfaction with VR use will be assessed using 7-point Likert scale for satisfaction and 5 brief multiple-choice experience questions
Sponsors and contacts
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