Clinical trial NCT01713322: Testing Educational Materials in a Paediatric Setting
Official title: Testing Educational Materials About Immunizations in a Paediatric Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Immunization
Keywords: parent education
pain management
immunization
infant
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
First posted: 2012-10-24
Enrollment: 160
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of pain management strategies utilized
timeFrame: During immunization
Secondary outcomes:
measure: Pain during infant immunizations
timeFrame: During immunization
measure: Parent behaviour during infant immunizations
timeFrame: During immunization
measure: Pain during infant immunizations as reported by parents
timeFrame: During immunization
measure: Parent-reported satisfaction with immunization experience
timeFrame: During immunization
measure: Duration of infant crying during immunizations
timeFrame: During immunization
measure: Pain during infant immunizations
timeFrame: During immunizations
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Health Center, Pediatric Clinic.
state: Ontario
Study officials:
affiliation: University of Toronto
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References: