Testing Educational Materials in a Paediatric Setting

Testing Educational Materials About Immunizations in a Paediatric Setting

Immunization procedures are a common source of iatrogenic pain for infants. A recently developed clinical practice guideline, led by Taddio et al., created evidence-based strategies for management of immunization pain. User-friendly educational tools outlining these strategies were made. The goal of cluster randomized controlled trial is to assess whether these educational materials increase utilization of pain-relieving strategies by parents during infant immunizations.

Study Overview

• Status: Unknown
• Conditions: Immunization
• Intervention / Treatment: Behavioral: Pain management education; Behavioral: No pain management education

Detailed Description

Immunization procedures are a common source of iatrogenic pain for infants. A recently developed clinical practice guideline led by Taddio et al. provides evidence-based recommendations for the management of immunization pain in children. User-friendly educational tools based on the guideline have also been developed, including a factsheet and educational video. The primary objective of this study is to assess whether these materials can increase utilization of pain -relieving strategies by parents during immunizations. Parents will be recruited during their infant's 2-month or 4-month scheduled visit to receive either the educational material related to immunization pain management (intervention group) or general information about immunization (control group). The study team will then follow these infants at their current and upcoming immunizations visit and document the pain management strategies utilized, infant pain responses, and parental satisfaction with pain management.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • Recruiting
      • St. Michael's Health Center, Pediatric Clinic.
      • Contact: Micheal Sgro, MD; Phone Number: 6560 416-864-6060; Email: SgroM@smh.ca
      • Sub-Investigator: Micheal Sgro, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parents of 2 or 4-month old healthy infants during routine immunization appointments
• Parent accompanies infant at immunization appointments

Exclusion Criteria:

• Parents of infants <30 weeks gestational age (GA)
• Parents delaying infant immunization for >2 months
• Parents who are unable to read and understand English
• Infants with congenital anomalies, neurological conditions, and maternal psychiatric conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain management education; Parents are provided with educational material on how to manage child pain during immunization.	Behavioral: Pain management education; Parents are provided with educational material on how to manage child pain during immunization.
Other: No pain management education; Control - parents receive general information about childhood immunization.	Behavioral: No pain management education; Control - parents receive general information about childhood immunization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of pain management strategies utilized	The number of pain management strategies utilized during immunization injections measured post-intervention from videotapes by a blinded assessor.	During immunization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during infant immunizations	Pain during infant immunizations, as measured by a validated measure of pain in infants, the Modified Behavioural Pain Scale (MBPS), by trained and blinded research assistants.	During immunization
Parent behaviour during infant immunizations	Parent behaviour during infant immunizations, as measured by Measure of Adult and Infant Soothing and Distress (MAISD) tool by trained and blinded research assistants.	During immunization
Pain during infant immunizations as reported by parents	Pain during immunization appointments, as reported by parents using the Numerical Rating Scale (NRS), in real-time.	During immunization
Parent-reported satisfaction with immunization experience	Parent-reported satisfaction with their immunization experience in their infant during immunization appointments on a 5-point Likert scale.	During immunization
Duration of infant crying during immunizations	Duration of infant crying during infant immunizations, measured in seconds, will be assessed from videotapes by a trained and blinded assessor.	During immunization
Pain during infant immunizations	Pain during infant immunizations will be assessed by researchers, in real time, using the Numerical Rating Scale (NRS)	During immunizations

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: Unity Health Toronto
• Investigators: Principal Investigator: Anna Taddio, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: October 21, 2012
• First Submitted That Met QC Criteria: October 21, 2012
• First Posted (Estimate): October 24, 2012

Study Record Updates

• Last Update Posted (Estimate): December 24, 2012
• Last Update Submitted That Met QC Criteria: December 21, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: infant; pain management; parent education; immunization
• Other Study ID Numbers: 12-195C