Testing Educational Materials in a Paediatric Setting

Immunization Clinical Trial

Official title:

Testing Educational Materials About Immunizations in a Paediatric Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01713322
• Other study ID #: 12-195C
• Status: Recruiting
• Phase: Phase 3
• First received: October 21, 2012
• Last updated: December 21, 2012
• Start date: November 2012

Study information

• Verified date: December 2012
• Source: University of Toronto
• Contact: Anna Taddio, PhD
• Phone: 416-978-8822
• Email: anna.taddio[@]utoronto.ca
• Is FDA regulated: No
• Health authority: Canada: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immunization

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Michael's Health Center, Pediatric Clinic.	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain during infant immunizations	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.	During immunization	No
Secondary	Parent behaviour during infant immunizations	Parent behaviour during infant immunizations, as measured by Measure of Adult and Infant Soothing and Distress (MAISD) tool by trained and blinded research assistants.	During immunization	No
Secondary	Pain during infant immunizations as reported by parents	Pain during immunization appointments, as reported by parents using the Numerical Rating Scale (NRS), in real-time.	During immunization	No
Secondary	Parent-reported satisfaction with immunization experience	Parent-reported satisfaction with their immunization experience in their infant during immunization appointments on a 5-point Likert scale.	During immunization	No
Secondary	Duration of infant crying during immunizations	Duration of infant crying during infant immunizations, measured in seconds, will be assessed from videotapes by a trained and blinded assessor.	During immunization	No
Secondary	Pain during infant immunizations	Pain during infant immunizations will be assessed by researchers, in real time, using the Numerical Rating Scale (NRS)	During immunizations	No