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Prenatal Education About Infant Immunization Pain Management

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01707212
First Posted: October 16, 2012
Last Update Posted: October 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mount Sinai Hospital, New York
Information provided by (Responsible Party):
Anna Taddio, University of Toronto
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Further study details as provided by Anna Taddio, University of Toronto:

Primary Outcome 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 Outcome 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


Other Outcome Measures:
  • 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)


Enrollment: 197
Study Start Date: October 2012
Study Completion Date: July 2013
Primary Completion Date: July 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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707212


Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
University of Toronto
Mount Sinai Hospital, New York
  More Information

Responsible Party: Anna Taddio, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT01707212     History of Changes
Other Study ID Numbers: 12-0134-E
First Submitted: October 11, 2012
First Posted: October 16, 2012
Last Update Posted: October 29, 2013
Last Verified: October 2013

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

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs