NCT01637779

A Randomized Controlled Trial About Teaching Parents How to Manage Childhood Immunization Pain

A Randomized Clinical Trial to Evaluate the Impact of a Fact Sheet About Childhood Immunization Pain Management on Parental Knowledge

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Toronto · Academic / Other
• Sex: Female
• Age: 15 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

There is no effect of a parent-directed fact sheet about pain management during childhood immunization and pre-test on parent learning about evidence-based pain relieving methods.

Detailed description

Over 90% of young children demonstrate severe distress during vaccination. Pain relieving strategies are uncommonly used, despite a plethora of evidence for physical, pharmacological and psychological techniques. Parents commonly report pain as a harm-related concern for childhood immunizations and are dissatisfied with current practices. Unmitigated pain causes long-term adverse sequelae, including; anticipatory fear and hypersensitivity to pain at future procedures in children, and parental non-compliance with immunization schedules. Health providers and parents report the major barrier to routine use of pain management is parental lack of knowledge about effective strategies. Lack of time is reported as a secondary barrier. An educational tool about immunization pain management targeted to parents that can be practically implemented in the clinical setting within usual time constraints is needed.

Conditions

• Mothers of Newborn Infants

Interventions

Type	Name	Description
BEHAVIORAL	Fact sheet	fact sheet about pain management during immunization

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-07-11
• Last updated: 2013-10-29

Locations

1 site across 1 country: Canada