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A Randomized Controlled Trial About Teaching Parents How to Manage Childhood Immunization Pain

This study is currently recruiting participants.
Verified October 2012 by University of Toronto
Sponsor:
Collaborator:
The Hospital for Sick Children
Information provided by (Responsible Party):
Anna Taddio, University of Toronto
ClinicalTrials.gov Identifier:
NCT01637779
First received: July 8, 2012
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
  Purpose

There is no effect of a parent-directed fact sheet about pain management during childhood immunization and pre-test on parent learning about evidence-based pain relieving methods.


Condition Intervention Phase
Mothers of Newborn Infants
 Behavioral: Fact sheet
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: A Randomized Clinical Trial to Evaluate the Impact of a Fact Sheet About Childhood Immunization Pain Management on Parental Knowledge

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • knowledge [ Time Frame: 10 minutes after intervention (educational material) ] [ Designated as safety issue: No ]
    maternal knowledge will be evaluated after reading the fact sheet or control (material unrelated to immunization)


Secondary Outcome Measures:
  • utilization of pain relieving interventions [ Time Frame: 2 months after intervention ] [ Designated as safety issue: No ]
    maternal self-reported use of pain relieving interventions during routine 2-month infant immunizations


Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fact sheet review
mothers will review a fact sheet containing information about pain management during immunization then complete a knowledge test afterward
 Behavioral: Fact sheet
fact sheet about pain management during immunization
Placebo Comparator: control unrelated material
mothers will review material unrelated to pain management during immunization then complete a knowledge test
 Behavioral: Fact sheet
fact sheet about pain management during immunization
Experimental: pre-test, review of fact sheet
mothers do a pre-test, then read a fact sheet about how to manage immunization pain, then repeat the test
 Behavioral: Fact sheet
fact sheet about pain management during immunization
Placebo Comparator: pre-test, control unrelated information
mothers do a pre-test, then read unrelated material, then repeat the test
 Behavioral: Fact sheet
fact sheet about pain management during immunization

Detailed Description:

Over 90% of young children demonstrate severe distress during vaccination. Pain relieving strategies are uncommonly used, despite a plethora of evidence for physical, pharmacological and psychological techniques. Parents commonly report pain as a harm-related concern for childhood immunizations and are dissatisfied with current practices. Unmitigated pain causes long-term adverse sequelae, including; anticipatory fear and hypersensitivity to pain at future procedures in children, and parental non-compliance with immunization schedules. Health providers and parents report the major barrier to routine use of pain management is parental lack of knowledge about effective strategies. Lack of time is reported as a secondary barrier. An educational tool about immunization pain management targeted to parents that can be practically implemented in the clinical setting within usual time constraints is needed.

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • new mothers with health full-term infants
  • 5 minute Apgar 7 or more

Exclusion Criteria:

  • non-english speaking mothers
  • mothers with psychiatric conditions
  • infants admitted to intensive care unit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637779

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: Anna Taddio, PhD     416-978-8822     anna.taddio@utoronto.ca    
Contact: Vibhuti Shah, MD     416-586-4816     vshah@mtsinai.on.ca    
Principal Investigator: Vibhuti Shah, MD            
Sponsors and Collaborators
University of Toronto
The Hospital for Sick Children
Investigators
Principal Investigator: Anna Taddio, PhD University of Toronto
  More Information

No publications provided

Responsible Party: Anna Taddio, Associate Professor, Leslie Dan Faculty of Pharmacy, University of Toronto
ClinicalTrials.gov Identifier: NCT01637779     History of Changes
Other Study ID Numbers: 11-0231-E, 1000032989
Study First Received: July 8, 2012
Last Updated: October 11, 2012
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on May 16, 2013