A Randomized Controlled Trial About Teaching Parents How to Manage Childhood Immunization Pain
A Randomized Clinical Trial to Evaluate the Impact of a Fact Sheet About Childhood Immunization Pain Management on Parental Knowledge
2 other identifiers
interventional
120
1 country
1
Brief Summary
There is no effect of a parent-directed fact sheet about pain management during childhood immunization and pre-test on parent learning about evidence-based pain relieving methods.
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 Jul 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
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 8, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedOctober 29, 2013
October 1, 2013
7 months
July 8, 2012
October 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
knowledge
maternal knowledge will be evaluated after reading the fact sheet or control (material unrelated to immunization)
10 minutes after intervention (educational material)
Secondary Outcomes (1)
utilization of pain relieving interventions
2 months after intervention
Study Arms (4)
fact sheet review
EXPERIMENTALmothers will review a fact sheet containing information about pain management during immunization then complete a knowledge test afterward
control unrelated material
PLACEBO COMPARATORmothers will review material unrelated to pain management during immunization then complete a knowledge test
pre-test, review of fact sheet
EXPERIMENTALmothers do a pre-test, then read a fact sheet about how to manage immunization pain, then repeat the test
pre-test, control unrelated information
PLACEBO COMPARATORmothers do a pre-test, then read unrelated material, then repeat the test
Interventions
fact sheet about pain management during immunization
Eligibility Criteria
You may qualify if:
- new mothers with health full-term infants
- minute Apgar 7 or more
You may not qualify if:
- non-english speaking mothers
- mothers with psychiatric conditions
- infants admitted to intensive care unit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Torontolead
- The Hospital for Sick Childrencollaborator
Study Sites (1)
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Taddio, PhD
University of Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Leslie Dan Faculty of Pharmacy
Study Record Dates
First Submitted
July 8, 2012
First Posted
July 11, 2012
Study Start
July 1, 2012
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
October 29, 2013
Record last verified: 2013-10