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临床试验/NCT01637779
NCT01637779已完成3 期

A Randomized Clinical Trial to Evaluate the Impact of a Fact Sheet About Childhood Immunization Pain Management on Parental Knowledge

University of Toronto2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年7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
120
试验地点
2
主要终点
knowledge

研究概览

简要总结

There is no effect of a parent-directed fact sheet about pain management during childhood immunization and pre-test on parent learning about evidence-based pain relieving methods.

详细描述

Over 90% of young children demonstrate severe distress during vaccination. Pain relieving strategies are uncommonly used, despite a plethora of evidence for physical, pharmacological and psychological techniques. Parents commonly report pain as a harm-related concern for childhood immunizations and are dissatisfied with current practices. Unmitigated pain causes long-term adverse sequelae, including; anticipatory fear and hypersensitivity to pain at future procedures in children, and parental non-compliance with immunization schedules. Health providers and parents report the major barrier to routine use of pain management is parental lack of knowledge about effective strategies. Lack of time is reported as a secondary barrier. An educational tool about immunization pain management targeted to parents that can be practically implemented in the clinical setting within usual time constraints is needed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • new mothers with health full-term infants
  • 5 minute Apgar 7 or more

排除标准

  • non-english speaking mothers
  • mothers with psychiatric conditions
  • infants admitted to intensive care unit

结局指标

主要结局

knowledge

时间窗: 10 minutes after intervention (educational material)

maternal knowledge will be evaluated after reading the fact sheet or control (material unrelated to immunization)

次要结局

  • utilization of pain relieving interventions(2 months after intervention)

研究者

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

Anna Taddio

Associate Professor, Leslie Dan Faculty of Pharmacy

University of Toronto

研究点 (2)

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