Recruiting

Virtual RealityVirtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT06245395

Conditions

Virtual Reality

Otolaryngology

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Accepted

Interventions

Virtual Reality

Study Details

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.

Conditions

Virtual Reality

Otolaryngology

Study ID

NCT06245395

Start date

Oct 10, 2023

Status verified date

Feb, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Virtual Reality Arm

Pediatric patient receiving Virtual Reality during the otologic procedure.

no intervention: Standard of Care Arm

Interventions

Virtual Reality

Meta Quest 2 Headset

Primary outcome measure

Wong-Baker FACES Pain Scale [ Time Frame: during the in clinic procedure ]
Subjective Units of Distress Scale [ Time Frame: during the in clinic procedure ]

Central Contacts and Locations

Central contacts

Samuel Garrett, MD

4085298722 samlgarrett@gmail.com

Anthony Tolisano, MD

8609677563 anthony.m.tolisano.mil@health.mil

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Human Protections Director

301-295-8239 dha.bethesda.Walter-Reed-Med-Ctr.list.drp-leadership@health.mil

Principal Investigator:

Anthony Tolisano, MD

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Feb 22, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2024-02-22.