Buzzy: An Integration of Vibration, Cold, and Distraction for Pediatric Needle Pain Relief
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Faces Pain Scale-Revised (FPS-R)
研究概览
简要总结
A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of cannulation when compared to vapocoolant spray.
详细描述
Needle pain is the most common and the most feared source of childhood pain, resulting in needle phobia for 10% of adults. Current pain relief options include numbing creams, vapocoolant spray, or injected lidocaine. 17 million pediatric IV access procedures are done yearly with no pain intervention. An inexpensive, immediately acting form of needle pain control could reduce needle phobia in the long term if demonstrated to be effective for needle pain.
This study will evaluate pain self report and parent report using the Faces Pain Scale revised, and video-coded OSBD-R scores for patients undergoing emergency department venous access or cannulation procedures. Demographic information, pre-procedural anxiety, and success data from the attempts at placement will be included.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring venipuncture in a pediatric emergency department
- •Informed consent
- •Patient assent
- •Exclusion criteria:
- •Patients with sickle cell or other sensitivity to cold
- •Nerve damage in the area
- •Abrasion or break in skin where device would be placed
- •Critically ill
排除标准
- 未提供
研究组 & 干预措施
Standard Care
venipuncture with vapocoolant spray offered
干预措施: vapocoolant (Other)
Buzzy
Vibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards.
干预措施: Buzzy (Device)
结局指标
主要结局
Faces Pain Scale-Revised (FPS-R)
时间窗: 5 minute
Self-report measure of pain via 6 faces ranging from neutral to increasing pain expression. The scoring for the scale ranges from 0-10 with lower scores representing lower pain and higher scores representing higher pain. The FPS-R was conducted several minutes following venipuncture. This time was not tracked, but it was typically between 2-5 minutes following completion of the venipuncture.
次要结局
- Number of Participants With Venipuncture Success in One Attempt(5 minutes)
- OSBD-R Observational Pain/Distress Scale(5 minute)
研究者
Lindsey L Cohen, PhD
Principal Investigator
Georgia State University