Testing Educational Materials in a Paediatric Setting

University of Toronto

Status and phase: Unknown; Phase 3

Conditions: Immunization

Treatments: Behavioral: Pain management education; Behavioral: No pain management education

Study type: Interventional

Funder types: Other

Identifiers

NCT01713322

12-195C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Pain management education

Experimental group

Description:

Parents are provided with educational material on how to manage child pain during immunization.

Treatment:

Behavioral: Pain management education

No pain management education

Other group

Description:

Control - parents receive general information about childhood immunization.

Treatment:

Behavioral: No pain management education