A Hospital-based Postnatal Parent Education Intervention About Infant Immunizations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

3420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-09-30

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.

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Detailed Description

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Conditions

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Postpartum Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

General information about infant immunizations at birth of a newborn infant

Group Type PLACEBO_COMPARATOR

Control

Intervention Type BEHAVIORAL

General information about infant immunizations at birth of a newborn infant

Low intensity intervention

Pamphlet with information about pain management during infant immunizations at birth of a newborn infant

Group Type ACTIVE_COMPARATOR

Low intensity intervention

Intervention Type BEHAVIORAL

Pamphlet with information about pain management during infant immunizations at birth of a newborn infant

High intensity intervention

Pamphlet and video with information about pain management during infant immunizations at birth of a newborn infant

Group Type ACTIVE_COMPARATOR

High intensity intervention

Intervention Type BEHAVIORAL

Pamphlet and video with information about pain management during immunizations at birth of a newborn infant

Interventions

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Low intensity intervention

Pamphlet with information about pain management during infant immunizations at birth of a newborn infant

Intervention Type BEHAVIORAL

High intensity intervention

Pamphlet and video with information about pain management during immunizations at birth of a newborn infant

Intervention Type BEHAVIORAL

Control

General information about infant immunizations at birth of a newborn infant

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes