Testing Educational Materials in a Paediatric Setting

Phase 3

• Conditions: Immunization
• Interventions: Behavioral: Pain management education; Behavioral: No pain management education

• Registration Number: NCT01713322
• Lead Sponsor: University of Toronto

Brief Summary

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.

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 Timeline

• Study First Submitted: 2012-10-21
• Study First Submitted QC: 2012-10-21
• Study First Posted: 2012-10-24
• Study Start: 2012-11
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-21
• Last Update Posted: 2012-12-24
• Primary Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain management education	Pain management education	Parents are provided with educational material on how to manage child pain during immunization.
No pain management education	No pain management education	Control - parents receive general information about childhood immunization.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Michael's Health Center, Pediatric Clinic.; 🇨🇦 Toronto, Ontario, Canada