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

Phase 3

Completed

• Conditions: Mothers of Newborn Infants
• Interventions: Behavioral: Fact sheet

• Registration Number: NCT01637779
• Lead Sponsor: University of Toronto

Brief 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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-08
• Study First Submitted QC: 2012-07-08
• Study First Posted: 2012-07-11
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-26
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• new mothers with health full-term infants
• 5 minute Apgar 7 or more

Exclusion Criteria

• non-english speaking mothers
• mothers with psychiatric conditions
• infants admitted to intensive care unit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fact sheet review	Fact sheet	mothers will review a fact sheet containing information about pain management during immunization then complete a knowledge test afterward
control unrelated material	Fact sheet	mothers will review material unrelated to pain management during immunization then complete a knowledge test
pre-test, review of fact sheet	Fact sheet	mothers do a pre-test, then read a fact sheet about how to manage immunization pain, then repeat the test
pre-test, control unrelated information	Fact sheet	mothers do a pre-test, then read unrelated material, then repeat the test

Primary Outcome Measures

Name	Time	Method
knowledge	10 minutes after intervention (educational material)	maternal knowledge will be evaluated after reading the fact sheet or control (material unrelated to immunization)

Secondary Outcome Measures

Name	Time	Method
utilization of pain relieving interventions	2 months after intervention	maternal self-reported use of pain relieving interventions during routine 2-month infant immunizations

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada