Prenatal Education About Infant Immunization Pain Management

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: July 2013

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.

Interventions

  • Behavioral: Pain management education
    • Education about pain management during infant immunization
  • Behavioral: No pain management education
    • Control – no education about pain management during infant immunization

Arms, Groups and Cohorts

  • Experimental: Pain management education
    • Education about pain management during infant immunization
  • Other: No pain management education
    • Control – general information about immunization only

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Toronto
  • Collaborator
    • Mount Sinai Hospital, New York
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anna Taddio, Associate Professor – University of Toronto

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