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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
Parents are provided with educational material on how to manage child pain during immunization.
Control - parents receive general information about childhood immunization.
St. Michael's Health Center, Pediatric Clinic.
Toronto, Ontario, Canada
RECRUITINGNumber of pain management strategies utilized
The number of pain management strategies utilized during immunization injections measured post-intervention from videotapes by a blinded assessor.
Time frame: During immunization
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During immunization
Pain during infant immunizations
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Pain during infant immunizations will be assessed by researchers, in real time, using the Numerical Rating Scale (NRS)
Time frame: During immunizations