Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Wong Baker Faces
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Blind Randomization
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •between 3 to 10 years old
- •undergoes percutaneous pinning of an elbow fracture
排除标准
- •under age 3 or over age 10
- •unable to quantify or express their pain
- •Lack of parental consent
- •Absence of caregiver during procedure
研究组 & 干预措施
1Buzzy System with Flash Cards
1 Will use Buzzy System buzzing ice pack and flash cards
干预措施: Flash Cards (Other)
1Buzzy System with Flash Cards
1 Will use Buzzy System buzzing ice pack and flash cards
干预措施: Buzzy Ice pack (Device)
2 Flash Cards only
2 Parental distraction with Flash Cards only
干预措施: Flash Cards (Other)
结局指标
主要结局
Wong Baker Faces
时间窗: 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
时间窗: 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.
次要结局
- Parental Satisfaction Survey(within 10 minutes after procedure)