Testing Educational Materials About Immunizations in a Paediatric Setting
试验速览
- 阶段
- 3 期
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Number of pain management strategies utilized
研究概览
简要总结
Immunization procedures are a common source of iatrogenic pain for infants. A recently developed clinical practice guideline, led by Taddio et al., created evidence-based strategies for management of immunization pain. User-friendly educational tools outlining these strategies were made. The goal of cluster randomized controlled trial is to assess whether these educational materials increase utilization of pain-relieving strategies by parents during infant immunizations.
详细描述
Immunization procedures are a common source of iatrogenic pain for infants. A recently developed clinical practice guideline led by Taddio et al. provides evidence-based recommendations for the management of immunization pain in children. User-friendly educational tools based on the guideline have also been developed, including a factsheet and educational video. The primary objective of this study is to assess whether these materials can increase utilization of pain -relieving strategies by parents during immunizations. Parents will be recruited during their infant's 2-month or 4-month scheduled visit to receive either the educational material related to immunization pain management (intervention group) or general information about immunization (control group). The study team will then follow these infants at their current and upcoming immunizations visit and document the pain management strategies utilized, infant pain responses, and parental satisfaction with pain management.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Parents of 2 or 4-month old healthy infants during routine immunization appointments
- •Parent accompanies infant at immunization appointments
排除标准
- •Parents of infants <30 weeks gestational age (GA)
- •Parents delaying infant immunization for >2 months
- •Parents who are unable to read and understand English
- •Infants with congenital anomalies, neurological conditions, and maternal psychiatric conditions
结局指标
主要结局
Number of pain management strategies utilized
时间窗: During immunization
The number of pain management strategies utilized during immunization injections measured post-intervention from videotapes by a blinded assessor.
次要结局
- Pain during infant immunizations(During immunizations)
- Parent behaviour during infant immunizations(During immunization)
- Pain during infant immunizations as reported by parents(During immunization)
- Parent-reported satisfaction with immunization experience(During immunization)
- Duration of infant crying during immunizations(During immunization)
研究者
Anna Taddio
Associate Professor
University of Toronto