Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures

Walter Reed National Military Medical Center

Status: Enrolling

Conditions: Otolaryngology; Virtual Reality

Treatments: Device: Virtual Reality

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06245395

WalterReedNMMC - ENT

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Virtual Reality Arm

Active Comparator group

Description:

Pediatric patient receiving Virtual Reality during the otologic procedure.

Treatment:

Device: Virtual Reality

Standard of Care Arm

No Intervention group