Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures

Not Applicable

Recruiting

• Conditions: Virtual Reality; Otolaryngology
• Interventions: Device: Virtual Reality

• Registration Number: NCT06245395
• Lead Sponsor: Walter Reed National Military Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-10
• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Status Verified: 2024-02
• Study First Posted: 2024-02-07
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Arm	Virtual Reality	Pediatric patient receiving Virtual Reality during the otologic procedure.

Primary Outcome Measures

Name	Time	Method
Wong-Baker FACES Pain Scale	during the in clinic procedure
Subjective Units of Distress Scale	during the in clinic procedure

Trial Locations

Locations (1)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States