A Hospital-based Postnatal Parent Education Intervention About Infant Immunizations

Phase 3

• Conditions: Postpartum Women
• Interventions: Behavioral: High intensity intervention; Behavioral: Control; Behavioral: Low intensity intervention

• Registration Number: NCT01937143
• Lead Sponsor: University of Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-09-03
• Study First Posted: 2013-09-09
• Study Start: 2013-10
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-21
• Primary Completion: 2017-08
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 3420

Inclusion Criteria

• mothers rooming in with infants on postnatal ward

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Exclusion Criteria

• mothers with significant psychiatric conditions
• mothers unable to communicate in English
• mothers sharing room whereby another mother already participated

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High intensity intervention	High intensity intervention	Pamphlet and video with information about pain management during infant immunizations at birth of a newborn infant
Control	Control	General information about infant immunizations at birth of a newborn infant
Low intensity intervention	Low intensity intervention	Pamphlet with information about pain management during infant immunizations at birth of a newborn infant

Primary Outcome Measures

Name	Time	Method
Analgesic utilization	Up to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Knowledge	Up to 6 months	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.
Immunization compliance	Up to 6 months	Parent self-reported compliance with infant immunization schedule, confirmed with health care provider if possible.
Attitudes	Up to 6 months	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.
Specific analgesic utilization	Up to 6 months	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.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada