Immunisation Anxiety Related Reaction Clinical Trial
Official title:
Improving the Vaccination Experience at School in Calgary
A multi-faceted knowledge translation intervention - The CARD (C-Comfort, A-Ask, R-Relax, D-Distract) System - was developed to improve the vaccination experience of students at school. CARD is a framework for delivering vaccinations that is student-centred that promotes coping. This study will examine the feasibility of CARD implementation procedures and measures in the school vaccination program in Calgary, Alberta for use in a larger cluster trial.
Vaccination is estimated to have saved more lives in Canada over the last 50 years than any
other single intervention and is considered one of the most important advances in the
prevention of disease. One major drawback of vaccination, however, is that the usual route of
administration involves a painful needle injection. In students undergoing school-based mass
vaccinations, vaccine injections frequently cause sever distress and fainting, with some
serious injuries resulting from fainting. Concerns about pain and/or needle fear are also
directly responsible for vaccine refusal in this population.
An evidence based clinical practice guideline for mitigating vaccine injection pain, fear and
fainting has been developed, however, it is not yet implemented across different school-based
vaccination settings and students are not benefiting from the research evidence. In a prior
small-scale project, investigators developed and implemented a multi-faceted knowledge
translation intervention - The CARD (C-Comfort, A-Ask, R-Relax, D-Distract) System - in some
schools in a small public health region in Niagara, Ontario. CARD is a framework for
delivering vaccinations that is student-centred and promotes coping. It integrates
recommendations from the guideline in two separate components of the vaccination delivery
program: 1) pre-vaccination day preparation, and 2) vaccination day activities. Investigators
found preliminary evidence of acceptability, appropriateness, satisfaction and clinical
effectiveness of CARD when used in grade 7 students in Niagara.
In this study, investigators plan to determine the feasibility of implementing CARD in a
diverse and more complex public health region in Calgary, Alberta. Specifically,
investigators will determine recruitment rates, adherence to CARD protocol, response rates
for questionnaires, acceptability, appropriateness (fit), and satisfaction. The results will
inform a future cluster trial.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04103801 -
Substance P as a Biomarker to Evaluate the Reduction of Multiple Immunization Pain
|
N/A |