Elbow Fractures
Conditions
Keywords
Pin Pulling
Brief summary
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
OTHERFlash Cards
1 Flash cards for distraction
DEVICEBuzzy Ice pack
1 Buzzy system with Flash Cards
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Blind Randomization
Intervention model description
a randomized control trial
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wong Baker Faces | within 10 minutes after procedure | Faces with different emotions ranging from no pain to most pain. Faces are scored from 0 to 10 with higher scores indicating higher levels of pain. |
| Children's Fear Scale | within 10 minutes after procedure | Faces with different emotions from no anxiety to most anxiety. Faces are scored from 0 to 4 with higher scores indicating higher levels of anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Satisfaction Survey | within 10 minutes after procedure | Parents are asked to rate the following statements on a 1 to 5 Likert Scale with 1 being "No" and 5 being "Definitely". Experimental Arm: 1. My child was comforted by the use of the Distraction Cards and Buzzy system during the procedure 2. It was a positive Experience 3. I think the Buzzy System is easy to use 4. I would like to use the Buzzy System in the future for invasive procedure for my son/daughter Control Arm: 1. My child was comforted by the use of the Distraction Cards during the procedure 2. It was a positive experience 3. I would like the option to use additional distraction methods like the Buzzy System in the future for invasive procedure for my son/daughter |
Countries
United States
Contacts
CONTACTKathy Edge, CRC
CONTACTChristopher McCormick, BA
PRINCIPAL_INVESTIGATORKacy Richburg, MD
University of Oklahoma
Outcome results
None listed