Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06245395

Enrollment

100

Registered

2024-02-07

Start date

2023-10-10

Completion date

2024-12-31

Last updated

2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otolaryngology, Virtual Reality

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.

Interventions

DEVICEVirtual Reality

Meta Quest 2 Headset

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to 17 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactSamuel Garrett, MD

samlgarrett@gmail.com4085298722

Backup ContactAnthony Tolisano, MD

anthony.m.tolisano.mil@health.mil8609677563

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026