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

Purpose

The goal of this study is to determine if the Buzzy System, a vibrating ice pack shaped like a bee reduces pain in removal of elbow fracture pin.

Condition

  • Elbow Fractures

Eligibility

Eligible Ages
Between 3 Years and 10 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • between 3 to 10 years old - undergoes percutaneous pinning of an elbow fracture

Exclusion Criteria

  • under age 3 or over age 10 - unable to quantify or express their pain - Lack of parental consent - Absence of caregiver during procedure

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
a randomized control trial
Primary Purpose
Supportive Care
Masking
None (Open Label)
Masking Description
Blind Randomization

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
1Buzzy System with Flash Cards 		1 Will use Buzzy System buzzing ice pack and flash cards
  • Other: Flash Cards
    1 Flash cards for distraction
  • Device: Buzzy Ice pack
    1 Buzzy system with Flash Cards
Active Comparator
2 Flash Cards only 		2 Parental distraction with Flash Cards only
  • Other: Flash Cards
    1 Flash cards for distraction

Recruiting Locations

OU Health Children's
Oklahoma City, Oklahoma 73104

OU Health
Oklahoma City, Oklahoma 73104

More Details

Status
Recruiting
Sponsor
University of Oklahoma

Study Contact

Kathy Edge, CRC
405-271-4426
Kathy-edge@ou.edu

Detailed Description

Perform a randomized single blind control trial in children ages 3 to 10 to determine if the Buzzy System, a vibrating cold application system reduces pain, measured by the Wong-Baker Faces Pain Rating, and also reduce fear associated with the procedure measured through the Children's Fear Scale by the child and parents and the doctor pulling the pins.