NCT01713322

Testing Educational Materials in a Paediatric Setting

Testing Educational Materials About Immunizations in a Paediatric Setting

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University of Toronto · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Immunization

Interventions

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

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-09-01
• First posted: 2012-10-24
• Last updated: 2012-12-24

Locations

1 site across 1 country: Canada