NCT01937143

A Hospital-based Postnatal Parent Education Intervention About Infant Immunizations

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,420 (estimated)
• Sponsor: University of Toronto · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Postpartum Women

Interventions

Type	Name	Description
BEHAVIORAL	Low intensity intervention	Pamphlet with information about pain management during infant immunizations at birth of a newborn infant
BEHAVIORAL	High intensity intervention	Pamphlet and video with information about pain management during immunizations at birth of a newborn infant
BEHAVIORAL	Control	General information about infant immunizations at birth of a newborn infant

Timeline

• Start date: 2013-10-01
• Primary completion: 2017-08-01
• Completion: 2018-09-01
• First posted: 2013-09-09
• Last updated: 2016-09-21

Locations

1 site across 1 country: Canada