NCT06245395

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

January 29, 2024

Last Update Submit

February 21, 2024

Conditions

Virtual RealityOtolaryngology

Outcome Measures

Primary Outcomes (2)

  • Wong-Baker FACES Pain Scale

    during the in clinic procedure

  • Subjective Units of Distress Scale

    during the in clinic procedure

Study Arms (2)

Virtual Reality Arm

ACTIVE COMPARATOR

Pediatric patient receiving Virtual Reality during the otologic procedure.

Device: Virtual Reality

Standard of Care Arm

NO INTERVENTION

Interventions

Virtual RealityDEVICE

Meta Quest 2 Headset

Virtual Reality Arm

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients, ages 7-17 years old, undergoing an in-office microscope ear examination with possible debridement/instrumentation by a single fellowship trained neurotologist .

You may not qualify if:

  • \) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

RECRUITING

Study Officials

  • Anthony Tolisano, MD

    WRNMMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Garrett, MD

CONTACT

4085298722samlgarrett@gmail.com

Anthony Tolisano, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 7, 2024

Study Start

October 10, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations

US(1)