Prenatal Education About Infant Immunization Pain Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Immunization

Intervention / Treatment
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* Behavioral: Pain management education
* Behavioral: No pain management education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain management education<br>Education about pain management during infant immunization | Behavioral: Pain management education<br>* Education about pain management during infant immunization<br>|
| Other: No pain management education<br>Control - general information about immunization only | Behavioral: No pain management education<br>* Control - no education about pain management during infant immunization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utilization of pain management strategies during infant immunization | Parents will self-report utilization of specific pain management strategies during routine 2-month infant immunization | within 2 months of immunization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | within 2 months of immunization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parent education, pain management, immunization, infant