Painful Procedures in the Emergency Department: A Distraction Intervention (3-5 Year Olds) (ERPain)
Painful Procedures in the Emergency Department: Does a Formal Program in Distracting Techniques for Parents and Children Reduce Pain and Anxiety in Children (3-5 Year Olds)?
研究概览
详细说明
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 (3-5 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.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Nova Scotia
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Halifax、Nova Scotia、加拿大、B3K 6R8
- IWK Health Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Participants will be eligible for this study if they:
- Are between 3-5 years of age
- Are presenting in the IWK Emergency Department requiring venipuncture for blood collection or intravenous (IV) initiation.
- Are able to read and speak English
- Provide written parental authorization
Exclusion Criteria:
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
- Require sedation for the venipuncture as determined by the ED staff
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Treatment
50% randomized to receive distraction intervention during painful procedure
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Cognitive-Behavioral/Relaxation Intervention
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无干预:Control
50% RANDOMIZED TO RECEIVE NO INTERVENITON
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
手术过程中录制的视觉疼痛反应视频的 CAMPIS 编码
大体时间:连续的
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连续的
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次要结果测量
结果测量 |
大体时间 |
---|---|
儿童焦虑等级
大体时间:后处理
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后处理
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CHEOPS分析
大体时间:后处理
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后处理
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Parental reports of: Child pain ratings (Faces Pain Scale Revised)
大体时间:post-procedure
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post-procedure
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 3416
- Mayday grant
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PAT的临床试验
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Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完全的
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Emory UniversityNational Institute of Neurological Disorders and Stroke (NINDS)招聘中
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Centre Hospitalier Universitaire Saint Pierre终止
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Pennine Acute Hospitals NHS TrustUniversity Hospitals, Leicester; University of Manchester; University of Salford未知
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Heart and Diabetes Center North-Rhine WestfaliaItamar-Medical, Israel完全的