Immunizing Infants Against Pain: a Hospital-based Postnatal Parent Education Intervention About Infant Immunizations
试验速览
- 阶段
- 3 期
- 入组人数
- 3,420
- 试验地点
- 2
- 主要终点
- Analgesic utilization
研究概览
简要总结
Immunization injections are the most common recurring painful medical procedure undertaken in childhood. Numerous evidence-based and feasible interventions are available to mitigate immunization pain, however, there is low uptake of these interventions in clinical practice, revealing a knowledge-to-care gap between what is known about pain and pain management. This is a 4-year single-centre, randomized, parallel 3-group add-on trial that will enrol 3420 mothers hospitalized following the birth of an infant at Mount Sinai Hospital (MSH) in Toronto. The trial will evaluate and compare the impact of two levels of intensity of maternal education about pain management during infant immunizations ('low': pamphlet vs. 'high': pamphlet + video) compared to placebo control after the birth of an infant on maternal behaviour during future infant immunizations at up to 6 months of age (use of analgesic interventions), maternal knowledge and attitudes about pain and pain management up to 6 months after birth.
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
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •mothers rooming in with infants on postnatal ward
排除标准
- •mothers with significant psychiatric conditions
- •mothers unable to communicate in English
- •mothers sharing room whereby another mother already participated
结局指标
主要结局
Analgesic utilization
时间窗: Up to 6 months
Parent self-reported use of any of the 3 most effective analgesic interventions (breastfeeding, sugar water, or topical anesthetics) at infant immunization; the specific time period for the outcome assessment is at either 2, 4 or 6 month infant immunization, based on a random allocation process.
次要结局
- Knowledge(Up to 6 months)
- Immunization compliance(Up to 6 months)
- Attitudes(Up to 6 months)
- Specific analgesic utilization(Up to 6 months)
研究者
Anna Taddio
Professor, Leslie Dan Faculty of Pharmacy
University of Toronto
