Randomized Controlled Trial to Compare Buzzy and Hand-held Computer Distraction for Pain Control in Children Underwent Venipuncture.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Self-reported pain
研究概览
简要总结
Venipuncture is one of the most common iatrogenic painful and stressful procedures performed on children. Interventions aimed at reducing the distress related to this experience are widely and strongly recommended. Pain and anxiety management is even more essential because it may modify children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Distraction is the most studied psychological technique to relieve venipuncture related pain and distress, with a strong evidence supporting its efficacy in children and adolescents.
In recent years several studies showed the effectiveness of a specific tool named Buzzy® (MMJ Labs, Atlanta GA, USA), in relieving pain and distress in children. Buzzy combines distraction and physical analgesia (vibration and cold) and it was positively tested during venipuncture, intravenous cannulation and painful injections in children. Even though its efficacy it's well established, most of the published trials did not compare Buzzy with other interventions, so that little data are available about its usefulness compared with other distractions techniques.
Hand-held computers are reusable tools, which offer a technological-based active distraction. There is evidence supporting their used during painful procedures such as venipuncture and a recent published study showed that hand-held computer distraction was as effective as nurse-led passive distraction techniques in children.
The aim of this study is to compare the effectiveness of Buzzy versus hand-held computer in pain relief during venipuncture.
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children from 4 to 12 years of age needing venipuncture
排除标准
- •the presence of damage, denuded or broken skin in the site of Buzzy application;
- •use of topical, enteral or parenteral analgesics within eight hours before enrolment;
- •the presence of cognitive impairment or the inability to report pain verbally;
- •the presence of chronic disease, included epilepsy, or of diseases associated with cold hypersensitivity (i.e., sickle cell anaemia, Raynaud's disease).
结局指标
主要结局
Self-reported pain
时间窗: Within 5 minutes after the procedure
Children from 4 to 7 years of age record their pain using the Faces Pain Scale-Revised (FPS-R); children from 8 to 12 years using a Numerical Rating Scale, with scores from zero to 10.
次要结局
- Pain evaluated by parents(Within 5 minutes after the procedure)
- Success at first attempt(Intraprocedural)
- Pain evaluated by nurses(Within 5 minutes after the procedure)
- Adverse events(Up to 15 minutes after the procedure)
研究者
Luca Ronfani
Head of Clinical Epidemiology and Public Health Research Unit
IRCCS Burlo Garofolo