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临床试验/NCT01937143
NCT01937143Unknown3 期

Immunizing Infants Against Pain: a Hospital-based Postnatal Parent Education Intervention About Infant Immunizations

University of Toronto2 个研究点 分布在 1 个国家目标入组 3,420 人开始时间: 2013年10月最近更新:
适应症

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

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

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

Anna Taddio

Professor, Leslie Dan Faculty of Pharmacy

University of Toronto

研究点 (2)

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