Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flash Cards, Buzzy Ice pack.
- Who it may be relevant to
- Registry conditions: Elbow Fractures. Basic parameters: 3 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Other Flash Cards
1 Flash cards for distraction - Device Buzzy Ice pack
1 Buzzy system with Flash Cards
Primary outcome measures
- Wong Baker Faces [Time frame: within 10 minutes after procedure]
- Children's Fear Scale [Time frame: within 10 minutes after procedure]
Secondary outcome measures (1)
- Parental Satisfaction Survey [Time frame: within 10 minutes after procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- OU Health Children's — Oklahoma City
- OU Health — Oklahoma City
Identifiers
NCT: NCT07520851 · 18347P