Painful Procedures in the Emergency Department:Does a Formal Program in Distracting Techniques for Parents and Children Reduce Pain and Anxiety in Children?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- CAMPIS coding of visual pain response video-recorded during the procedure
研究概览
简要总结
This study is designed to assess the effectiveness of the video-based intervention over and above current standard practice for pain control in the pediatric emergency department (ED). This is a single-center trial based at the IWK Health Centre. The primary outcome will be based on the CAMPIS coding of the video-taped pain response of the research participants.
详细描述
The purpose of this study is to determine if the pain and anxiety that children experience when they have venipuncture procedures performed can be reduced by a video-based distraction and coping strategy intervention. An instructional video has been designed to educate parents and children about what is going to happen during the venipuncture procedure; to teach coping skills that can be used before and during the painful procedure; and to provide distraction during the procedure by using an entertaining video segment.
Approximately 168 children (6-12 years of age)who are seen in the IWK ED requiring venipunctures for blood collection or IV starts will be randomized. PArent and child training in distraction and coping strategies will be provided by means of a self-administered video-delivery via a portable DVD player. Fifty percent of the eligible participants will receive the distraction and coping strategies intervention and 50% will receive the standard medical care provided by the IWK ED. Those receiving standard care will be evaluated for outcome results and then be compared to the intervention group. It is expected that children who receive the intervention will report less pain and anxiety associated with venipunctures than those who receive standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be eligible for this study if they:
- •are between 6-12 years of age
- •are presenting in the IWK Emergency Department who require a venipuncture for blood collection or IV initiation.
- •are able to read and speak english
- •provide written parental authorization and verbal child assent
排除标准
- •Participants will be excluded for this study if they:
- •are in critical condition as determined by ED staff
- •are in significant pain for other reasons other than the venipuncture
- •have severe cognitive delay
- •who require sedation for the venipuncture as determined by the ED staff
结局指标
主要结局
CAMPIS coding of visual pain response video-recorded during the procedure
时间窗: continuous
次要结局
- Child pain ratings (Faces Pain Scale Revised)(post procedure)
- Child anxiety ratings(post procedure)
- CHEOPS analysis(post procedure)