Active vs. Passive VR During Office-based ENT Procedures

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Passive virtual reality headset or goggles

    Device

    Exposure 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

    Device

    Exposure to interactive game through virtual reality using Paperplane Therapeutics software with a VR headset or glasses during common in-office ENT procedures.

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: Passive virtual realityExperimental treatment 1 intervention
Group B: Active virtual realityExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Immediately after the office-based ENT procedure
2

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.

Time frame
Immediately after the office-based ENT procedure

Secondary outcomes

1

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.

Time frame
Immediately after the office-based ENT procedure

Other outcomes

1

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.

Time frame
Immediately after the office-based ENT procedure

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: