A Hospital-based Postnatal Parent Education Intervention About Infant Immunizations

Postpartum Women Clinical Trial

— IIAP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01937143
• Other study ID #: 126007
• Secondary ID: 126007
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 26, 2013
• Last updated: September 19, 2016
• Start date: October 2013
• Est. completion date: September 2018

Study information

• Verified date: September 2016
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Mount Sinai Hospital Research Ethics BoardCanada: University of Toronto Health Sciences Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3420
• Est. completion date: September 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postpartum Women

Intervention

Behavioral:
• Low intensity intervention
Pamphlet 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
• Control
General information about infant immunizations at birth of a newborn infant

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	Yes
Secondary	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	No
Secondary	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.	Up to 6 months	No
Secondary	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	Yes
Secondary	Immunization compliance	Parent self-reported compliance with infant immunization schedule, confirmed with health care provider if possible.	Up to 6 months	No