Prenatal Education About Infant Immunization Pain Management

October 26, 2013 updated by: Anna Taddio, University of Toronto

A Prenatal Education Module for Parents to Improve the Use of Pain-management Strategies for Immunization in Two-month Old Infants: a Randomized Controlled Trial of Knowledge Translation

There are numerous pain management strategies available for the management of infant immunization pain. The majority of infants, however do not benefit from these interventions, which causes them to suffer pain unnecessarily. This study will assess the impact of educating parents about pain management strategies on their knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is ample literature outlining effective pain management strategies for immunization including psychological, physical and pharmacological interventions; however their use in clinical practice has been limited. Teaching parents about these strategies in an enriching setting such as prenatal education classes has the potential to increase utilization of these strategies, and empower parents to take on a more active role in the management of their infant's pain during routine immunization. Educating parents about pain-management for infant immunization has not been previously investigated in this setting. The aim of this cluster-randomized controlled trial is to evaluate the effectiveness of an immunization pain-management education module added to the prenatal education program at Mount Sinai Hospital on parental knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.

Study Type

Interventional

Enrollment (Actual)

197

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • mothers attending weekend prenatal classes
  • delivery of a healthy newborn > 35 weeks gestational age
  • available for followup for infant's 2-month immunization

Exclusion Criteria:

  • mothers who do not plan to immunize their infants
  • infant with major birth defect or hospitalized at time of immunization
  • mothers who need to attend the prenatal class at a separate time when education not offered

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
Experimental: Pain management education
Education about pain management during infant immunization
Behavioral: Pain management education
Education about pain management during infant immunization
Other: No pain management education
Control - general information about immunization only
Behavioral: No pain management education
Control - no education about pain management during infant immunization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utilization of pain management strategies during infant immunization
Time Frame: within 2 months of immunization
Parents will self-report utilization of specific pain management strategies during routine 2-month infant immunization
within 2 months of immunization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attempted use of pain management strategies during infant immunization
Time Frame: within 2 months of immunization
Parents will self-reported attempted utilization of specific pain management strategies at 2-month infant immunization
within 2 months of immunization
Knowledge
Time Frame: within 2 months of immunization
Parents will answer questions regarding their knowledge about the effectiveness of various pain management strategies for infant immunization injections
within 2 months of immunization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant pain during immunization
Time Frame: within 2 months of immunization
Parents will self-report infant pain during 2-month immunization using an 11-point Numerical Rating Scale (NRS)
within 2 months of immunization

Collaborators and Investigators

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

Sponsor

University of Toronto

Collaborators

Mount Sinai Hospital, New York

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, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

October 11, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 16, 2012

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 26, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12-0134-E

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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