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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1Buzzy System with Flash Cards | Active Comparator | 1 Will use Buzzy System buzzing ice pack and flash cards |
|
| 2 Flash Cards only | Active Comparator | 2 Parental distraction with Flash Cards only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flash Cards | Other | 1 Flash cards for distraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wong Baker Faces | 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. | within 10 minutes after procedure |
| Children's Fear Scale | 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. | within 10 minutes after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Parental Satisfaction Survey | 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:
Control Arm:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathy Edge, CRC | Contact | 405-271-4426 | 47988 | Kathy-edge@ou.edu |
| Christopher McCormick, BA | Contact | 405-271-3480 | 34260 | Christopher-McCormick@ou.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kacy Richburg, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OU Health Children's | Recruiting | Oklahoma City | Oklahoma | 73104 | United States | |
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| ID | Term |
|---|---|
| D000092482 | Elbow Fractures |
| ID | Term |
|---|---|
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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a randomized control trial
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Blind Randomization
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| Buzzy Ice pack | Device | 1 Buzzy system with Flash Cards |
|
| within 10 minutes after procedure |
| OU Health |
| Recruiting |
| Oklahoma City |
| Oklahoma |
| 73104 |
| United States |