Prenatal Education About Infant Immunization Pain Management
A Prenatal Education Module for Parents to Improve the Use of Pain-management Strategies for Immunization in Two-month Old Infants: a Randomized Controlled Trial of Knowledge Translation
1 other identifier
interventional
197
1 country
1
Brief Summary
There are numerous pain management strategies available for the management of infant immunization pain. The majority of infants, however do not benefit from these interventions, which causes them to suffer pain unnecessarily. This study will assess the impact of educating parents about pain management strategies on their knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2012
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 11, 2012
CompletedFirst Posted
Study publicly available on registry
October 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedOctober 29, 2013
October 1, 2013
9 months
October 11, 2012
October 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Utilization of pain management strategies during infant immunization
Parents will self-report utilization of specific pain management strategies during routine 2-month infant immunization
within 2 months of immunization
Secondary Outcomes (2)
Attempted use of pain management strategies during infant immunization
within 2 months of immunization
Knowledge
within 2 months of immunization
Other Outcomes (1)
Infant pain during immunization
within 2 months of immunization
Study Arms (2)
Pain management education
EXPERIMENTALEducation about pain management during infant immunization
No pain management education
OTHERControl - general information about immunization only
Interventions
Education about pain management during infant immunization
Control - no education about pain management during infant immunization
Eligibility Criteria
You may qualify if:
- mothers attending weekend prenatal classes
- delivery of a healthy newborn \> 35 weeks gestational age
- available for followup for infant's 2-month immunization
You may not qualify if:
- mothers who do not plan to immunize their infants
- infant with major birth defect or hospitalized at time of immunization
- mothers who need to attend the prenatal class at a separate time when education not offered
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Torontolead
- Mount Sinai Hospital, New Yorkcollaborator
Study Sites (1)
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 11, 2012
First Posted
October 16, 2012
Study Start
October 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
October 29, 2013
Record last verified: 2013-10