Prenatal Education About Infant Immunization Pain Management
2013年10月26日 更新者：Anna Taddio、University of Toronto
A Prenatal Education Module for Parents to Improve the Use of Pain-management Strategies for Immunization in Two-month Old Infants: a Randomized Controlled Trial of Knowledge Translation
There are numerous pain management strategies available for the management of infant immunization pain.
The majority of infants, however do not benefit from these interventions, which causes them to suffer pain unnecessarily.
This study will assess the impact of educating parents about pain management strategies on their knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.
研究概览
详细说明
There is ample literature outlining effective pain management strategies for immunization including psychological, physical and pharmacological interventions; however their use in clinical practice has been limited.
Teaching parents about these strategies in an enriching setting such as prenatal education classes has the potential to increase utilization of these strategies, and empower parents to take on a more active role in the management of their infant's pain during routine immunization.
Educating parents about pain-management for infant immunization has not been previously investigated in this setting.
The aim of this cluster-randomized controlled trial is to evaluate the effectiveness of an immunization pain-management education module added to the prenatal education program at Mount Sinai Hospital on parental knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.
研究类型
介入性
注册 (实际的)
197
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Ontario
-
Toronto、Ontario、加拿大、M5G 1X5
- Mount Sinai Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 及以上 (孩子、成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- mothers attending weekend prenatal classes
- delivery of a healthy newborn > 35 weeks gestational age
- available for followup for infant's 2-month immunization
Exclusion Criteria:
- mothers who do not plan to immunize their infants
- infant with major birth defect or hospitalized at time of immunization
- mothers who need to attend the prenatal class at a separate time when education not offered
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Pain management education
Education about pain management during infant immunization
|
Education about pain management during infant immunization
|
|
其他：No pain management education
Control - general information about immunization only
|
Control - no education about pain management during infant immunization
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Utilization of pain management strategies during infant immunization
大体时间：within 2 months of immunization
|
Parents will self-report utilization of specific pain management strategies during routine 2-month infant immunization
|
within 2 months of immunization
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Attempted use of pain management strategies during infant immunization
大体时间：within 2 months of immunization
|
Parents will self-reported attempted utilization of specific pain management strategies at 2-month infant immunization
|
within 2 months of immunization
|
|
Knowledge
大体时间：within 2 months of immunization
|
Parents will answer questions regarding their knowledge about the effectiveness of various pain management strategies for infant immunization injections
|
within 2 months of immunization
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Infant pain during immunization
大体时间：within 2 months of immunization
|
Parents will self-report infant pain during 2-month immunization using an 11-point Numerical Rating Scale (NRS)
|
within 2 months of immunization
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年10月1日
初级完成 (实际的)
2013年7月1日
研究完成 (实际的)
2013年7月1日
研究注册日期
首次提交
2012年10月11日
首先提交符合 QC 标准的
2012年10月11日
首次发布 (估计)
2012年10月16日
研究记录更新
最后更新发布 (估计)
2013年10月29日
上次提交的符合 QC 标准的更新
2013年10月26日
最后验证
2013年10月1日
更多信息
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