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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator 1Buzzy System with Flash Cards |
1 Will use Buzzy System buzzing ice pack and flash cards |
|
|
Active Comparator 2 Flash Cards only |
2 Parental distraction with Flash Cards only |
|
Recruiting Locations
OU Health Children's
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
OU Health
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
More Details
- Status
- Recruiting
- Sponsor
- University of Oklahoma
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.