Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2024-12-31

Brief Summary

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The primary aim of this randomized controlled trial is to determine the efficacy of Virtual Reality in pediatric otolaryngology clinics as distraction analgesia and anxiolysis for patients undergoing otologic procedures.

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Detailed Description

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Conditions

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Virtual Reality Otolaryngology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual Reality Arm

Pediatric patient receiving Virtual Reality during the otologic procedure.

Group Type ACTIVE_COMPARATOR

Virtual Reality

Intervention Type DEVICE

Meta Quest 2 Headset

Standard of Care Arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality

Meta Quest 2 Headset

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients, ages 7-17 years old, undergoing an in-office microscope ear examination with possible debridement/instrumentation by a single fellowship trained neurotologist .

Exclusion Criteria

* 1\) patients with a history of chronic pain disorders 2) developmental delay including autism spectrum disorders 3) neurologic or seizure disorders 4) visual impairment 5) claustrophobia

Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes