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A Hospital-based Postnatal Parent Education Intervention About Infant Immunizations (IIAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01937143
Recruitment Status : Unknown
Verified September 2016 by Anna Taddio, University of Toronto.
Recruitment status was:  Active, not recruiting
First Posted : September 9, 2013
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
Anna Taddio, University of Toronto

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.

Condition or disease Intervention/treatment Phase
Postpartum Women Behavioral: Low intensity intervention Behavioral: High intensity intervention Behavioral: Control Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immunizing Infants Against Pain: a Hospital-based Postnatal Parent Education Intervention About Infant Immunizations
Study Start Date : October 2013
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Placebo Comparator: Control
General information about infant immunizations at birth of a newborn infant
Behavioral: Control
General information about infant immunizations at birth of a newborn infant

Active Comparator: Low intensity intervention
Pamphlet with information about pain management during infant immunizations at birth of a newborn infant
Behavioral: Low intensity intervention
Pamphlet with information about pain management during infant immunizations at birth of a newborn infant

Active Comparator: High intensity intervention
Pamphlet and video with information about pain management during infant immunizations at birth of a newborn infant
Behavioral: High intensity intervention
Pamphlet and video with information about pain management during immunizations at birth of a newborn infant




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Knowledge [ Time Frame: 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.

  2. Attitudes [ Time Frame: 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.

  3. Specific analgesic utilization [ Time Frame: 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.

  4. Immunization compliance [ Time Frame: Up to 6 months ]
    Parent self-reported compliance with infant immunization schedule, confirmed with health care provider if possible.


Other Outcome Measures:
  1. Attempted analgesic utilization [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937143


Locations
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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
University of Toronto
Investigators
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Principal Investigator: Anna Taddio, PhD University of Toronto
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anna Taddio, Professor, Leslie Dan Faculty of Pharmacy, University of Toronto
ClinicalTrials.gov Identifier: NCT01937143    
Other Study ID Numbers: 126007
126007 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Posted: September 9, 2013    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016
Keywords provided by Anna Taddio, University of Toronto:
parent education
immunization
vaccination
infant
pain management