A Hospital-based Postnatal Parent Education Intervention About Infant Immunizations

Study Overview
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Brief Summary
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Immunization injections are the most common recurring painful medical procedure undertaken in childhood. Numerous evidence-based and feasible interventions are available to mitigate immunization pain, however, there is low uptake of these interventions in clinical practice, revealing a knowledge-to-care gap between what is known about pain and pain management. This is a 4-year single-centre, randomized, parallel 3-group add-on trial that will enrol 3420 mothers hospitalized following the birth of an infant at Mount Sinai Hospital (MSH) in Toronto. The trial will evaluate and compare the impact of two levels of intensity of maternal education about pain management during infant immunizations ('low': pamphlet vs. 'high': pamphlet + video) compared to placebo control after the birth of an infant on maternal behaviour during future infant immunizations at up to 6 months of age (use of analgesic interventions), maternal knowledge and attitudes about pain and pain management up to 6 months after birth.

Official Title
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Immunizing Infants Against Pain: a Hospital-based Postnatal Parent Education Intervention About Infant Immunizations

Conditions
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Postpartum Women

Intervention / Treatment
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* Behavioral: Low intensity intervention
* Behavioral: High intensity intervention
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mothers rooming in with infants on postnatal ward Exclusion Criteria: mothers with significant psychiatric conditions mothers unable to communicate in English mothers sharing room whereby another mother already participated

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Placebo Comparator: Control<br>General information about infant immunizations at birth of a newborn infant | Behavioral: Control<br>* General information about infant immunizations at birth of a newborn infant<br>|
| Active Comparator: Low intensity intervention<br>Pamphlet with information about pain management during infant immunizations at birth of a newborn infant | Behavioral: Low intensity intervention<br>* Pamphlet with information about pain management during infant immunizations at birth of a newborn infant<br>|
| Active Comparator: High intensity intervention<br>Pamphlet and video with information about pain management during infant immunizations at birth of a newborn infant | Behavioral: High intensity intervention<br>* Pamphlet and video with information about pain management during immunizations at birth of a newborn infant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic utilization | Parent self-reported use of any of the 3 most effective analgesic interventions (breastfeeding, sugar water, or topical anesthetics) at infant immunization; the specific time period for the outcome assessment is at either 2, 4 or 6 month infant immunization, based on a random allocation process. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge | Parent knowledge about effective analgesic interventions for mitigating pain at infant immunization; the specific time period for the outcome assessment is at either 2, 4 or 6 month infant immunization, based on a random allocation process. | Up to 6 months | 
| Attitudes | Parent self-reported attitudes about pain/pain management at infant immunization; the specific time period for the outcome assessment is at either 2, 4 or 6 month infant immunization, based on a random allocation process. | Up to 6 months | 
| Specific analgesic utilization | Parent self-reported utilization of specific analgesic interventions at infant immunization; the specific time period for the outcome assessment is at either 2, 4 or 6 month infant immunization, based on a random allocation process. | Up to 6 months | 
| Immunization compliance | Parent self-reported compliance with infant immunization schedule, confirmed with health care provider if possible. | Up to 6 months | 

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