Actively Recruiting

Phase Not Applicable
Age: 3Years - 10Years
All Genders
Healthy Volunteers
ID07520851

Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal

Led by University of Oklahoma · Updated on 2026-04-17

75

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the Buzzy System, a vibrating ice pack shaped like a bee, to see if it can reduce pain and fear during the removal of elbow fracture pins in children aged 3 to 10 years. The study is a randomized single-blind controlled trial aiming to measure pain using the Wong-Baker Faces Pain Rating and fear using the Children's Fear Scale, reported by the child, parents, and doctor. Participants will be randomly assigned to one of two groups: one using the Buzzy System along with flash cards for distraction, and the other using flash cards alone for parental distraction. The study compares the effectiveness of the Buzzy System device in reducing pain and fear during the pin removal procedure. Children will be assessed within 10 minutes after the procedure using the pain and fear scales. Parents will also complete a satisfaction survey shortly after. The study involves monitoring pain, fear, and parental satisfaction to evaluate the device's impact during the pin removal process. Participation includes the procedure and follow-up assessments during the same visit.

CONDITIONS

Brief Title

Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal

Who Can Participate

Age: 3Years - 10Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 3 to 10 years old
  • Undergoes percutaneous pinning of an elbow fracture
Not Eligible

You will not qualify if you...

  • Under age 3 or over age 10
  • Unable to quantify or express their pain
  • Lack of parental consent
  • Absence of caregiver during procedure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Procedure day

Participants undergo pin removal of an elbow fracture using either the Buzzy System with Flash Cards or Flash Cards only to help reduce pain and fear during the procedure.

1 visit (in-person) on procedure day

Trial Site Locations

Total: 2 locations

1

OU Health Children's

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

2

OU Health

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

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Research Team

K

Kathy Edge, CRC

C

Christopher McCormick, BA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Frequently Asked Questions

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