MedTrace Logo

A Hospital-based Postnatal Parent Education Intervention About Infant Immunizations

NCT01937143 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3420

Last updated 2016-09-21

No results posted yet for this study

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.

Conditions

  • Postpartum Women

Interventions

BEHAVIORAL

Low intensity intervention

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

BEHAVIORAL

High intensity intervention

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

BEHAVIORAL

Control

General information about infant immunizations at birth of a newborn infant

Sponsors & Collaborators

  • University of Toronto

    lead OTHER

Principal Investigators

  • Anna Taddio, PhD · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-08-31
Completion
2018-09-30

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01937143 on ClinicalTrials.gov