NCT01707212

Prenatal Education About Infant Immunization Pain Management

A Prenatal Education Module for Parents to Improve the Use of Pain-management Strategies for Immunization in Two-month Old Infants: a Randomized Controlled Trial of Knowledge Translation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: University of Toronto · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

There are numerous pain management strategies available for the management of infant immunization pain. The majority of infants, however do not benefit from these interventions, which causes them to suffer pain unnecessarily. This study will assess the impact of educating parents about pain management strategies on their knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.

Detailed description

There is ample literature outlining effective pain management strategies for immunization including psychological, physical and pharmacological interventions; however their use in clinical practice has been limited. Teaching parents about these strategies in an enriching setting such as prenatal education classes has the potential to increase utilization of these strategies, and empower parents to take on a more active role in the management of their infant's pain during routine immunization. Educating parents about pain-management for infant immunization has not been previously investigated in this setting. The aim of this cluster-randomized controlled trial is to evaluate the effectiveness of an immunization pain-management education module added to the prenatal education program at Mount Sinai Hospital on parental knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.

Conditions

• Immunization

Interventions

Type	Name	Description
BEHAVIORAL	Pain management education	Education about pain management during infant immunization
BEHAVIORAL	No pain management education	Control - no education about pain management during infant immunization

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-10-16
• Last updated: 2013-10-29

Locations

1 site across 1 country: Canada