Randomized Controlled Trial to Evaluate Tablet Distraction for Pain Control in Children Underwent Venipuncture
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Pain score recorded by the Faces Pain Scale-Revised (FPS-R)
研究概览
简要总结
Venipuncture is one of the painful procedures most frequently performed in children. Pain and distress management in children, during needle related procedures, is warranted.
The base for pain management starts with behavioural and environmental support and distraction. Distraction is a cognitive strategy trying to divert the child's attention from a noxious stimulus. Active distraction involves the child in a different performance, e.g. playing, during pain procedures. Passive distraction redirects the child's attention to visual or auditory stimuli using toys, songs, movies or blowing bubbles.
Blood-drawing centre is a peculiar setting in which many procedures have to be performed in a limited time. Patients usually arrive without a pharmacological premedication and go away immediately after procedure. In this context distraction is an excellent pain relief tool.
The aim of the study is to compare the effectiveness of an active distraction (playing a videogame using a computer tablet) with a passive distraction technique in pain relief during venipuncture in a blood-drawing centre.
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
入排标准
- 年龄范围
- 4 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4 to 13 years
- •Need for venipuncture
- •Informed consent signed by parents or legal guardians
排除标准
- •Children with epilepsy
- •Use of topical, enteral or parenteral analgesics within 8 hours before the procedure
- •Inability to perform venipuncture on hand or arm
- •Children with cognitive impairment or unable to report their pain verbally
结局指标
主要结局
Pain score recorded by the Faces Pain Scale-Revised (FPS-R)
时间窗: Intraprocedural (an average of 5 minutes)
The pain during the procedure will be evaluated using the self-reported FPS-R scale
次要结局
- Success at first attempt(Intraprocedural (an average of 5 minutes))
- Adverse events(Up to 15 minutes after the procedure)
研究者
Ronfani Luca
MD, PhD
IRCCS Burlo Garofolo