Prenatal Education About Infant Immunization Pain Management

University of Toronto197 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

197

Conditions

Immunization

Interventions

Pain management educationBEHAVIORAL

Education about pain management during infant immunization

No pain management educationBEHAVIORAL

Control - no education about pain management during infant immunization

Eligibility

Sex: FEMALEMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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

Locations (1)

Mount Sinai Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Utilization of pain management strategies during infant immunization

Parents will self-report utilization of specific pain management strategies during routine 2-month infant immunization

Time frame: within 2 months of immunization

Secondary Outcomes

Attempted use of pain management strategies during infant immunization

Parents will self-reported attempted utilization of specific pain management strategies at 2-month infant immunization

Time frame: within 2 months of immunization

Knowledge

Parents will answer questions regarding their knowledge about the effectiveness of various pain management strategies for infant immunization injections

Time frame: within 2 months of immunization

Data from ClinicalTrials.gov

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