A Randomized Clinical Trial to Evaluate the Impact of a Fact Sheet About Childhood Immunization Pain Management on Parental Knowledge
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
pre-test, control unrelated information
mothers do a pre-test, then read unrelated material, then repeat the test
干预措施: Fact sheet (Behavioral)
fact sheet review
mothers will review a fact sheet containing information about pain management during immunization then complete a knowledge test afterward
干预措施: Fact sheet (Behavioral)
control unrelated material
mothers will review material unrelated to pain management during immunization then complete a knowledge test
干预措施: Fact sheet (Behavioral)
pre-test, review of fact sheet
mothers do a pre-test, then read a fact sheet about how to manage immunization pain, then repeat the test
干预措施: Fact sheet (Behavioral)
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
Anna Taddio
Associate Professor, Leslie Dan Faculty of Pharmacy
University of Toronto
