Postpartum Women
Conditions
Keywords
parent education, immunization, vaccination, infant, pain management
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.
Interventions
BEHAVIORALLow intensity intervention
Pamphlet with information about pain management during infant immunizations at birth of a newborn infant
BEHAVIORALHigh intensity intervention
Pamphlet and video with information about pain management during immunizations at birth of a newborn infant
BEHAVIORALControl
General information about infant immunizations at birth of a newborn infant
Sponsors
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic utilization | 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
| Measure | Time frame | Description |
|---|---|---|
| Knowledge | Up to 6 months | 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. |
| Attitudes | Up to 6 months | 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. |
| Specific analgesic utilization | Up to 6 months | 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. |
| Immunization compliance | Up to 6 months | Parent self-reported compliance with infant immunization schedule, confirmed with health care provider if possible. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Attempted analgesic utilization | Up to 6 months | Parent self-reported attempted (and failed) 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. |
Countries
Canada
Outcome results
None listed