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Prenatal Education About Infant Immunization Pain Management

This study is currently recruiting participants.
Verified October 2012 by University of Toronto
Sponsor:
Collaborator:
Mount Sinai Hospital, New York
Information provided by (Responsible Party):
Anna Taddio, University of Toronto
ClinicalTrials.gov Identifier:
NCT01707212
First received: October 11, 2012
Last updated: October 21, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Immunization
 Behavioral: Pain management education
Behavioral: No pain management education
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Prenatal Care
U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Utilization of pain management strategies during infant immunization [ Time Frame: within 2 months of immunization ] [ Designated as safety issue: No ]
    Parents will self-report utilization of specific pain management strategies during routine 2-month infant immunization


Secondary Outcome Measures:
  • Attempted use of pain management strategies during infant immunization [ Time Frame: within 2 months of immunization ] [ Designated as safety issue: No ]
    Parents will self-reported attempted utilization of specific pain management strategies at 2-month infant immunization

  • Knowledge [ Time Frame: within 2 months of immunization ] [ Designated as safety issue: No ]
    Parents will answer questions regarding their knowledge about the effectiveness of various pain management strategies for infant immunization injections


Other Outcome Measures:
  • Infant pain during immunization [ Time Frame: within 2 months of immunization ] [ Designated as safety issue: No ]
    Parents will self-report infant pain during 2-month immunization using an 11-point Numerical Rating Scale (NRS)


Estimated Enrollment: 156
Study Start Date: October 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pain management education
Education about pain management during infant immunization
 Behavioral: Pain management education
Education about pain management during infant immunization
No pain management education
Control - general information about immunization only
 Behavioral: No pain management education
Control - no education about pain management during infant immunization

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707212

Contacts
Contact: Anna Taddio, PhD 416-978-8822 anna.taddio@utoronto.ca
Contact: Vibhuti Shah, MD 416-586-4816 vshah@mtsinai.on.ca

Locations
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Vibhuti Shah, MD     416-586-4816     vshah@mtsinai.on.ca    
Contact: Anna Taddio, PhD     416-978-8822     anna.taddio@utoronto.ca    
Principal Investigator: Vibhuti Shah, MD            
Sponsors and Collaborators
University of Toronto
Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: Anna Taddio, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT01707212     History of Changes
Other Study ID Numbers: 12-0134-E
Study First Received: October 11, 2012
Last Updated: October 21, 2012
Health Authority: Canada: Research Ethics Committee

Keywords provided by University of Toronto:
parent education
pain management
immunization
infant

ClinicalTrials.gov processed this record on May 23, 2013