Testing Educational Materials in a Paediatric Setting

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Toronto
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Anna Taddio, University of Toronto
ClinicalTrials.gov Identifier:
NCT01713322
First received: October 21, 2012
Last updated: December 21, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Immunization
Behavioral: Pain management education
Behavioral: No pain management education
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testing Educational Materials About Immunizations in a Paediatric Setting

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Number of pain management strategies utilized [ Time Frame: During immunization ] [ Designated as safety issue: No ]
    The number of pain management strategies utilized during immunization injections measured post-intervention from videotapes by a blinded assessor.


Secondary Outcome Measures:
  • Pain during infant immunizations [ Time Frame: During immunization ] [ Designated as safety issue: No ]
    Pain during infant immunizations, as measured by a validated measure of pain in infants, the Modified Behavioural Pain Scale (MBPS), by trained and blinded research assistants.

  • Parent behaviour during infant immunizations [ Time Frame: During immunization ] [ Designated as safety issue: No ]
    Parent behaviour during infant immunizations, as measured by Measure of Adult and Infant Soothing and Distress (MAISD) tool by trained and blinded research assistants.

  • Pain during infant immunizations as reported by parents [ Time Frame: During immunization ] [ Designated as safety issue: No ]
    Pain during immunization appointments, as reported by parents using the Numerical Rating Scale (NRS), in real-time.

  • Parent-reported satisfaction with immunization experience [ Time Frame: During immunization ] [ Designated as safety issue: No ]
    Parent-reported satisfaction with their immunization experience in their infant during immunization appointments on a 5-point Likert scale.

  • Duration of infant crying during immunizations [ Time Frame: During immunization ] [ Designated as safety issue: No ]
    Duration of infant crying during infant immunizations, measured in seconds, will be assessed from videotapes by a trained and blinded assessor.

  • Pain during infant immunizations [ Time Frame: During immunizations ] [ Designated as safety issue: No ]
    Pain during infant immunizations will be assessed by researchers, in real time, using the Numerical Rating Scale (NRS)


Estimated Enrollment: 160
Study Start Date: November 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pain management education
Parents are provided with educational material on how to manage child pain during immunization.
Behavioral: Pain management education
Parents are provided with educational material on how to manage child pain during immunization.
No pain management education
Control - parents receive general information about childhood immunization.
Behavioral: No pain management education
Control - parents receive general information about childhood immunization.

Detailed Description:

Immunization procedures are a common source of iatrogenic pain for infants. A recently developed clinical practice guideline led by Taddio et al. provides evidence-based recommendations for the management of immunization pain in children. User-friendly educational tools based on the guideline have also been developed, including a factsheet and educational video. The primary objective of this study is to assess whether these materials can increase utilization of pain -relieving strategies by parents during immunizations. Parents will be recruited during their infant's 2-month or 4-month scheduled visit to receive either the educational material related to immunization pain management (intervention group) or general information about immunization (control group). The study team will then follow these infants at their current and upcoming immunizations visit and document the pain management strategies utilized, infant pain responses, and parental satisfaction with pain management.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parents of 2 or 4-month old healthy infants during routine immunization appointments
  • Parent accompanies infant at immunization appointments

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713322

Contacts
Contact: Anna Taddio, PhD 416-978-8822 anna.taddio@utoronto.ca
Contact: Michael Sgro, MD 416-864-6060 ext 6560 sgrom@smh.ca

Locations
Canada, Ontario
St. Michael's Health Center, Pediatric Clinic. Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Micheal Sgro, MD    416-864-6060 ext 6560    SgroM@smh.ca   
Contact: Anna Taddio, PhD    416-978-8822    anna.taddio@utoronto.ca   
Sub-Investigator: Micheal Sgro, MD         
Sponsors and Collaborators
University of Toronto
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Anna Taddio, PhD University of Toronto
  More Information

No publications provided

Responsible Party: Anna Taddio, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT01713322     History of Changes
Other Study ID Numbers: 12-195C
Study First Received: October 21, 2012
Last Updated: December 21, 2012
Health Authority: Canada: Research Ethics Committee

Keywords provided by University of Toronto:
parent education
pain management
immunization
infant

ClinicalTrials.gov processed this record on August 19, 2014