Overview

This trial is active, not recruiting.

Condition postpartum women
Treatments low intensity intervention, high intensity intervention, control
Phase phase 3
Sponsor University of Toronto
Start date October 2013
End date August 2017
Trial size 3420 participants
Trial identifier NCT01937143, 126007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
General information about infant immunizations at birth of a newborn infant
control
General information about infant immunizations at birth of a newborn infant
(Active Comparator)
Pamphlet with information about pain management during infant immunizations at birth of a newborn infant
low intensity intervention
Pamphlet with information about pain management during infant immunizations at birth of a newborn infant
(Active Comparator)
Pamphlet and video with information about pain management during infant immunizations at birth of a newborn infant
high intensity intervention
Pamphlet and video with information about pain management during immunizations at birth of a newborn infant

Primary Outcomes

Measure
Analgesic utilization
time frame: Up to 6 months

Secondary Outcomes

Measure
Knowledge
time frame: Up to 6 months
Attitudes
time frame: Up to 6 months
Specific analgesic utilization
time frame: Up to 6 months
Immunization compliance
time frame: Up to 6 months

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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

Additional Information

Official title Immunizing Infants Against Pain: a Hospital-based Postnatal Parent Education Intervention About Infant Immunizations
Principal investigator Anna Taddio, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Toronto.