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 (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

Design model

Parallel

Treatments tested in this trial

  • Virtual reality headset or goggles

    Device

    Exposure to virtual reality via Paperplane Therapeutics software with 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

Pain assessed with visual analog scale

Pain assessed on VAS (visual analog scale of 0-100 mm)

Time frame
Immediately before and immediately after the office-based ENT procedure during a single study visit
2

Anxiety assessed with subjective units of distress scale

Anxiety assessed using Subjective Units of Distress scale (0-100)

Time frame
Immediately before and immediately after the office-based ENT procedure during a single study visit

Secondary outcomes

1

Clinician experience with VR use

Clinician experience with VR use assessing feasability and observed patient comfort using 7-point Likert scale

Time frame
Immediately after the office-based ENT procedure during a single study visit

Other outcomes

1

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

Time frame
Immediately after the office-based ENT procedure during a single study visit

Sponsors and contacts

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