Skip to main content
Clinical Trials/NCT01937143
NCT01937143
Unknown
Phase 3

Immunizing Infants Against Pain: a Hospital-based Postnatal Parent Education Intervention About Infant Immunizations

University of Toronto1 site in 1 country3,420 target enrollmentOctober 2013

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
September 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

Loading locations...

Similar Trials