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临床试验/NCT01707212
NCT01707212已完成3 期

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

University of Toronto2 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
197
试验地点
2
主要终点
Utilization of pain management strategies during infant immunization

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • mothers attending weekend prenatal classes
  • delivery of a healthy newborn > 35 weeks gestational age
  • available for followup for infant's 2-month immunization

排除标准

  • 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

结局指标

主要结局

Utilization of pain management strategies during infant immunization

时间窗: within 2 months of immunization

Parents will self-report utilization of specific pain management strategies during routine 2-month infant immunization

次要结局

  • Attempted use of pain management strategies during infant immunization(within 2 months of immunization)
  • Knowledge(within 2 months of immunization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Taddio

Associate Professor

University of Toronto

研究点 (2)

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