Recruiting
Phase 3

Observational Study

Sponsor:

University of Toronto

Code:

NCT01713322

Conditions

Immunization

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Interventions

Pain management education

No pain management education

Study Details

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.

Conditions

Immunization

Study ID

NCT01713322

Start date

Nov, 2012

Status verified date

Dec, 2012

Primary completion date

Sep, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

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

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pain management education

Parents are provided with educational material on how to manage child pain during immunization.

other: No pain management education

Control - parents receive general information about childhood immunization.

Interventions

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.

Primary outcome measure

  • Number of pain management strategies utilized [ Time Frame: During immunization ]

Central Contacts and Locations

Central contacts

Anna Taddio, PhD

416-978-8822anna.taddio@utoronto.ca

Michael Sgro, MD

416-864-6060sgrom@smh.ca

Locations

St. Michael's Health Center, Pediatric Clinic.

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Micheal Sgro, MD

416-864-6060SgroM@smh.ca

Anna Taddio, PhD

416-978-8822anna.taddio@utoronto.ca

More Information

Sponsor

University of Toronto

Last update posted

Dec 24, 2012

Last verified

Dec, 2012

Keywords

  • parent education
  • pain management
  • immunization
  • infant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2012-12-24.