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| ID | Type | Description | Link |
|---|---|---|---|
| 126007 | Other Grant/Funding Number | Canadian Institutes of Health Research |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | General information about infant immunizations at birth of a newborn infant |
|
| Low intensity intervention | Active Comparator | Pamphlet with information about pain management during infant immunizations at birth of a newborn infant |
|
| High intensity intervention | Active Comparator | Pamphlet and video with information about pain management during infant immunizations at birth of a newborn infant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity intervention | Behavioral | Pamphlet with information about pain management during infant immunizations at birth of a newborn infant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months |
| Attitudes |
| Measure | Description | Time Frame |
|---|---|---|
| Attempted analgesic utilization | 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. | Up to 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Taddio, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30348739 | Derived | Taddio A, Shah V, Bucci L, MacDonald NE, Wong H, Stephens D. Effectiveness of a hospital-based postnatal parent education intervention about pain management during infant vaccination: a randomized controlled trial. CMAJ. 2018 Oct 22;190(42):E1245-E1252. doi: 10.1503/cmaj.180175. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| High intensity intervention | Behavioral | Pamphlet and video with information about pain management during immunizations at birth of a newborn infant |
|
| Control | Behavioral | General information about infant immunizations at birth of a newborn infant |
|
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. |
| 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. | Up to 6 months |
| Immunization compliance | Parent self-reported compliance with infant immunization schedule, confirmed with health care provider if possible. | Up to 6 months |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |