Immunizing Infants Against Pain: a Hospital-based Postnatal Parent Education Intervention About Infant Immunizations
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Postpartum Women
- Sponsor
- University of Toronto
- Enrollment
- 3420
- Locations
- 1
- Primary Endpoint
- Analgesic utilization
- Last Updated
- 9 years ago
Overview
Brief Summary
Immunization injections are the most common recurring painful medical procedure undertaken in childhood. Numerous evidence-based and feasible interventions are available to mitigate immunization pain, however, there is low uptake of these interventions in clinical practice, revealing a knowledge-to-care gap between what is known about pain and pain management. This is a 4-year single-centre, randomized, parallel 3-group add-on trial that will enrol 3420 mothers hospitalized following the birth of an infant at Mount Sinai Hospital (MSH) in Toronto. The trial will evaluate and compare the impact of two levels of intensity of maternal education about pain management during infant immunizations ('low': pamphlet vs. 'high': pamphlet + video) compared to placebo control after the birth of an infant on maternal behaviour during future infant immunizations at up to 6 months of age (use of analgesic interventions), maternal knowledge and attitudes about pain and pain management up to 6 months after birth.
Investigators
Anna Taddio
Professor, Leslie Dan Faculty of Pharmacy
University of Toronto
Eligibility Criteria
Inclusion Criteria
- •mothers rooming in with infants on postnatal ward
Exclusion Criteria
- •mothers with significant psychiatric conditions
- •mothers unable to communicate in English
- •mothers sharing room whereby another mother already participated
Outcomes
Primary Outcomes
Analgesic utilization
Time Frame: Up to 6 months
Parent self-reported use of any of the 3 most effective analgesic interventions (breastfeeding, sugar water, or topical anesthetics) at infant immunization; the specific time period for the outcome assessment is at either 2, 4 or 6 month infant immunization, based on a random allocation process.
Secondary Outcomes
- Knowledge(Up to 6 months)
- Immunization compliance(Up to 6 months)
- Attitudes(Up to 6 months)
- Specific analgesic utilization(Up to 6 months)