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

This study has been completed.
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 26, 2013
Last verified: October 2013

July 8, 2012
October 26, 2013
July 2012
February 2013   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01637779 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
A Randomized Controlled Trial About Teaching Parents How to Manage Childhood Immunization Pain
A Randomized Clinical Trial to Evaluate the Impact of a Fact Sheet About Childhood Immunization Pain Management on Parental Knowledge

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Mothers of Newborn Infants
Behavioral: Fact sheet
fact sheet about pain management during immunization
  • Experimental: fact sheet review
    mothers will review a fact sheet containing information about pain management during immunization then complete a knowledge test afterward
    Intervention: Behavioral: Fact sheet
  • Placebo Comparator: control unrelated material
    mothers will review material unrelated to pain management during immunization then complete a knowledge test
    Intervention: Behavioral: Fact sheet
  • 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
    Intervention: Behavioral: Fact sheet
  • Placebo Comparator: pre-test, control unrelated information
    mothers do a pre-test, then read unrelated material, then repeat the test
    Intervention: Behavioral: Fact sheet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Female
15 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01637779
11-0231-E, 1000032989
No
Anna Taddio, University of Toronto
University of Toronto
The Hospital for Sick Children
Principal Investigator: Anna Taddio, PhD University of Toronto
University of Toronto
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP