Immunization
Conditions
Keywords
parent education, pain management, immunization, infant
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.
Interventions
BEHAVIORALPain management education
Parents are provided with educational material on how to manage child pain during immunization.
BEHAVIORALNo pain management education
Control - parents receive general information about childhood immunization.
Sponsors
Unity Health Toronto
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pain during infant immunizations | During immunization | 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. |
| 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. |
Countries
Canada
Contacts
Primary ContactAnna Taddio, PhD
Backup ContactMichael Sgro, MD
Outcome results
None listed