Clinical Trials Logo

Clinical Trial Summary

There are numerous pain management strategies available for the management of infant immunization pain. The majority of infants, however do not benefit from these interventions, which causes them to suffer pain unnecessarily. This study will assess the impact of educating parents about pain management strategies on their knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.


Clinical Trial Description

There is ample literature outlining effective pain management strategies for immunization including psychological, physical and pharmacological interventions; however their use in clinical practice has been limited. Teaching parents about these strategies in an enriching setting such as prenatal education classes has the potential to increase utilization of these strategies, and empower parents to take on a more active role in the management of their infant's pain during routine immunization. Educating parents about pain-management for infant immunization has not been previously investigated in this setting. The aim of this cluster-randomized controlled trial is to evaluate the effectiveness of an immunization pain-management education module added to the prenatal education program at Mount Sinai Hospital on parental knowledge and behaviour regarding pain management during routine 2-month infant immunization injections. ;


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 NCT01707212
Study type Interventional
Source University of Toronto
Contact
Status Completed
Phase Phase 3
Start date October 2012
Completion date July 2013

See also
  Status Clinical Trial Phase
Completed NCT02526394 - Pertussis and Meningitis C Concomitant Vaccination in Adolescents Phase 4
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
Recruiting NCT01713322 - Testing Educational Materials in a Paediatric Setting Phase 3
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