Clinical Trials Logo

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.


Clinical Trial 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. ;


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


NCT number NCT01713322
Study type Interventional
Source University of Toronto
Contact Anna Taddio, PhD
Phone 416-978-8822
Email anna.taddio@utoronto.ca
Status Recruiting
Phase Phase 3
Start date November 2012

See also
  Status Clinical Trial Phase
Completed NCT02526394 - Pertussis and Meningitis C Concomitant Vaccination in Adolescents Phase 4
Completed NCT01707212 - Prenatal Education About Infant Immunization Pain Management Phase 3
Completed NCT01463176 - Music Therapy as Procedural Support for Young Children Undergoing Immunizations N/A
Completed NCT01193335 - Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants. Phase 4
Completed NCT04222595 - FluPRINT Study: Characterisation of the Immune and Transcriptional Response to LAIV N/A
Completed NCT05794113 - Comparing the Use of a Mobile App for Surveillance of Adverse Events Following Influenza Immunization to a Web-Based Platform N/A
Not yet recruiting NCT03705455 - Immunization Schedule Alert Platform N/A
Recruiting NCT01601197 - A Study of Two Injection Techniques to Reduce Pain in Infants Undergoing Immunization Phase 3
Completed NCT01296906 - Population Versus Practice-based Interventions to Increase Immunizations N/A
Completed NCT01399814 - Restricted Intravenous Fluid Regime Effects on Immunological Indicators of Elderly Patients Operated for Abdominal Cancer Phase 3
Completed NCT01390363 - Study of Adolescent Immunization Recall Systems N/A
Completed NCT02609035 - Immunization Services Model for Adult Rate Improvement N/A
Recruiting NCT02200276 - Influenza Immunization in Adults Over Age 75 N/A
Completed NCT01677702 - Study of Yili Lactoferrin ShuHua Milk in the Improvement of Human Immunization N/A
Recruiting NCT05213000 - Adjuvant Effect of Physical Exercise on Immune Response to COVID-19 Vaccination and Interactions With Stress N/A
Completed NCT03188692 - Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants Phase 3
Completed NCT02432430 - Comparison of Immunization Quality Improvement Dissemination Study N/A
Completed NCT01379846 - Study of TAK-816 in Healthy Infants Phase 3
Active, not recruiting NCT03943875 - GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose Phase 4
Completed NCT02819895 - PRIMM Trial (Phone Reminder for IMMunization) N/A