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Behavioural Intervention

Virtual Reality Arm for Virtual Reality

N/A

Recruiting

Led By Anthony Tolisano, MD

Research Sponsored by Walter Reed National Military Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the in clinic procedure

Awards & highlights

Study Summary

"This trial will test if Virtual Reality can help children feel less pain and anxiety during ear surgeries in the ENT clinic."

Who is the study for?

This trial is for children who need ear, nose, and throat (ENT) procedures. It's designed to see if Virtual Reality can help reduce their pain and anxiety during these procedures.Check my eligibility

What is being tested?

The study tests the use of Virtual Reality as a way to distract kids from pain and calm their nerves in pediatric ENT clinics while they undergo certain medical procedures.See study design

What are the potential side effects?

Virtual Reality is generally safe but may cause dizziness, nausea, or eye strain in some children.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the in clinic procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the in clinic procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the in clinic procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Subjective Units of Distress Scale

Wong-Baker FACES Pain Scale

Trial Design

2Treatment groups

Active Control

Group I: Virtual Reality ArmActive Control1 Intervention

Pediatric patient receiving Virtual Reality during the otologic procedure.

Group II: Standard of Care ArmActive Control1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Walter Reed National Military Medical CenterLead Sponsor

137 Previous Clinical Trials

34,388 Total Patients Enrolled

Anthony Tolisano, MDPrincipal InvestigatorWRNMMC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial currently open for enrollment?

"According to the details available on clinicaltrials.gov, patient recruitment is ongoing for this trial. The initial posting date of the trial was 10th October 2023, with the most recent update made on 29th January 2024."

Answered by AI

What is the upper limit on the number of individuals involved in this research investigation?

"Affirmative. Information from clinicaltrials.gov indicates that this investigation is currently seeking participants. Initially shared on October 10th, 2023, and most recently revised on January 29th, 2024, the study aims to enroll a total of 100 patients at one designated site."

Answered by AI

Is the research trial open to participants who are 65 years old and above?

"Participants aged between 7 and 17 are sought for this clinical investigation. There are a total of 19 trials focused on individuals under the age of majority, while there exist 37 studies catering to those above the age of retirement."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures

2023. "Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06245395.

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