Testing Educational Materials in a Paediatric Setting
1 other identifier
interventional
160
1 country
1
Brief Summary
Immunization procedures are a common source of iatrogenic pain for infants. A recently developed clinical practice guideline, led by Taddio et al., created evidence-based strategies for management of immunization pain. User-friendly educational tools outlining these strategies were made. The goal of cluster randomized controlled trial is to assess whether these educational materials increase utilization of pain-relieving strategies by parents during infant immunizations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 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
First Submitted
Initial submission to the registry
October 21, 2012
CompletedFirst Posted
Study publicly available on registry
October 24, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedDecember 24, 2012
December 1, 2012
10 months
October 21, 2012
December 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of pain management strategies utilized
The number of pain management strategies utilized during immunization injections measured post-intervention from videotapes by a blinded assessor.
During immunization
Secondary Outcomes (6)
Pain during infant immunizations
During immunization
Parent behaviour during infant immunizations
During immunization
Pain during infant immunizations as reported by parents
During immunization
Parent-reported satisfaction with immunization experience
During immunization
Duration of infant crying during immunizations
During immunization
- +1 more secondary outcomes
Study Arms (2)
Pain management education
EXPERIMENTALParents are provided with educational material on how to manage child pain during immunization.
No pain management education
OTHERControl - parents receive general information about childhood immunization.
Interventions
Parents are provided with educational material on how to manage child pain during immunization.
Control - parents receive general information about childhood immunization.
Eligibility Criteria
You may qualify if:
- Parents of 2 or 4-month old healthy infants during routine immunization appointments
- Parent accompanies infant at immunization appointments
You may not qualify if:
- Parents of infants \<30 weeks gestational age (GA)
- Parents delaying infant immunization for \>2 months
- Parents who are unable to read and understand English
- Infants with congenital anomalies, neurological conditions, and maternal psychiatric conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Torontolead
- Unity Health Torontocollaborator
Study Sites (1)
St. Michael's Health Center, Pediatric Clinic.
Toronto, Ontario, M5B 1W8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Taddio, PhD
University of Toronto
Central Study Contacts
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 21, 2012
First Posted
October 24, 2012
Study Start
November 1, 2012
Primary Completion
September 1, 2013
Last Updated
December 24, 2012
Record last verified: 2012-12