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.

Study Overview

• Status: Completed
• Conditions: Mothers of Newborn Infants
• Intervention / Treatment: Behavioral: Fact sheet

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
knowledge	maternal knowledge will be evaluated after reading the fact sheet or control (material unrelated to immunization)	10 minutes after intervention (educational material)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
utilization of pain relieving interventions	maternal self-reported use of pain relieving interventions during routine 2-month infant immunizations	2 months after intervention

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: The Hospital for Sick Children
• Investigators: Principal Investigator: Anna Taddio, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 8, 2012
• First Submitted That Met QC Criteria: July 8, 2012
• First Posted (Estimate): July 11, 2012

Study Record Updates

• Last Update Posted (Estimate): October 29, 2013
• Last Update Submitted That Met QC Criteria: October 26, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: randomized controlled trial; infant; pain management; parent education; immunization
• Other Study ID Numbers: 11-0231-E; 1000032989 (Other Identifier: The Hospital for Sick Children)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No