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Clinical Trials/NCT01707212
NCT01707212
Completed
Phase 3

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

University of Toronto1 site in 1 country197 target enrollmentOctober 2012
ConditionsImmunization

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Immunization
Sponsor
University of Toronto
Enrollment
197
Locations
1
Primary Endpoint
Utilization of pain management strategies during infant immunization
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
July 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anna Taddio

Associate Professor

University of Toronto

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Attempted use of pain management strategies during infant immunization(within 2 months of immunization)
  • Knowledge(within 2 months of immunization)

Study Sites (1)

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