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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3,420
Pamphlet with information about pain management during infant immunizations at birth of a newborn infant
Pamphlet and video with information about pain management during immunizations at birth of a newborn infant
General information about infant immunizations at birth of a newborn infant
Mount Sinai Hospital
Toronto, Ontario, Canada
Analgesic utilization
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.
Time frame: Up to 6 months
Knowledge
Parent knowledge about effective analgesic interventions for mitigating pain 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.
Time frame: Up to 6 months
Attitudes
Parent self-reported attitudes about pain/pain management 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.
Time frame: Up to 6 months
Specific analgesic utilization
Parent self-reported utilization of specific analgesic interventions 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.
Time frame: Up to 6 months
Immunization compliance
Parent self-reported compliance with infant immunization schedule, confirmed with health care provider if possible.
Time frame: Up to 6 months
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