A Hospital-based Postnatal Parent Education Intervention About Infant Immunizations (IIAP)

September 19, 2016 updated by: Anna Taddio, University of Toronto

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

3420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
General information about infant immunizations at birth of a newborn infant
Behavioral: Control
General information about infant immunizations at birth of a newborn infant
Active Comparator: Low intensity intervention
Pamphlet with information about pain management during infant immunizations at birth of a newborn infant
Behavioral: Low intensity intervention
Pamphlet with information about pain management during infant immunizations at birth of a newborn infant
Active Comparator: High intensity intervention
Pamphlet and video 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic utilization
Time Frame: 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.
Up to 6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attempted analgesic utilization
Time Frame: Up to 6 months
Parent self-reported attempted (and failed) 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Investigators

  • Principal Investigator: Anna Taddio, PhD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

September 3, 2013

First Posted (Estimate)

September 9, 2013

Study Record Updates

Last Update Posted (Estimate)

September 21, 2016

Last Update Submitted That Met QC Criteria

September 19, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 126007 (Other Grant/Funding Number: Canadian Institutes of Health Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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