Prenatal Education About Infant Immunization Pain Management

Phase 3

Completed

• Conditions: Immunization
• Interventions: Behavioral: Pain management education; Behavioral: No pain management education

• Registration Number: NCT01707212
• Lead Sponsor: University of Toronto

Brief 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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-16
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-26
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 197

Inclusion Criteria

• mothers attending weekend prenatal classes
• delivery of a healthy newborn > 35 weeks gestational age
• available for followup for infant's 2-month immunization

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Exclusion Criteria

• mothers who do not plan to immunize their infants
• infant with major birth defect or hospitalized at time of immunization
• mothers who need to attend the prenatal class at a separate time when education not offered

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain management education	Pain management education	Education about pain management during infant immunization
No pain management education	No pain management education	Control - general information about immunization only

Primary Outcome Measures

Name	Time	Method
Utilization of pain management strategies during infant immunization	within 2 months of immunization	Parents will self-report utilization of specific pain management strategies during routine 2-month infant immunization

Secondary Outcome Measures

Name	Time	Method
Attempted use of pain management strategies during infant immunization	within 2 months of immunization	Parents will self-reported attempted utilization of specific pain management strategies at 2-month infant immunization
Knowledge	within 2 months of immunization	Parents will answer questions regarding their knowledge about the effectiveness of various pain management strategies for infant immunization injections

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada