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Clinical Trials/NCT06245395
NCT06245395
Recruiting
N/A

Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures

Walter Reed National Military Medical Center1 site in 1 country100 target enrollmentOctober 10, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Virtual Reality
Sponsor
Walter Reed National Military Medical Center
Enrollment
100
Locations
1
Primary Endpoint
Wong-Baker FACES Pain Scale
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 10, 2023
End Date
December 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • 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

Outcomes

Primary Outcomes

Wong-Baker FACES Pain Scale

Time Frame: during the in clinic procedure

Subjective Units of Distress Scale

Time Frame: during the in clinic procedure

Study Sites (1)

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