Anxiety, Chronic Rhinosinusitis (CRS), Dysphonia, Eustachian Tube Dysfunction, Nasal Obstruction, Nasal Polyp, Pain, Subglottic Stenosis (SGS)
Conditions
Brief summary
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
DEVICEPassive 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
DEVICEActive 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.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 (RhinAer/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."
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Procedure Pain Assessed Using the Visual Analog Scale | Immediately after the office-based ENT procedure | 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 | Immediately after the office-based ENT procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinician Experience with Virtual Reality Use | Immediately after the office-based ENT procedure | 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. |
Countries
United States
Contacts
CONTACTDennis M Tang, MD
Outcome results
None listed