Perceived Discomfort Levels in Healthy Children Participating in Vaccine Research

When assessing the risks of a research protocol, review boards need to consider not only the possible harms but also the expected discomfort levels caused by the various study procedures. However, data on how children experience various study procedures are scarce. This study assessed perceived disc...

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Bibliographic Details
Published in:Journal of empirical research on human research ethics 2013-07, Vol.8 (3), p.66-72
Main Authors: Westra, Anna E., van Gils, Elske J. M., Aarts, Fenne, Rodenburg, Gerwin D., Veenhoven, Reinier H., Hak, Eelko, Scharloo, Margreet, Sukhai, Ram N., Wit, Jan M., de Beaufort, Inez, Sanders, Elisabeth (Lieke) A. M.
Format: Article
Language:English
Subjects:
Age Factors
Age groups
Bioethics
Biomedical Research - ethics
Child health services
Child, Preschool
Children
Childrens health
Expectations
Experimentation
Humans
Immunization
Infant
Medical research
Pain - etiology
Parents
Pediatrics
Perception
Phlebotomy
Phlebotomy - adverse effects
Questionnaires
Research Subjects
Review boards
Specimen Handling - adverse effects
Understanding Risk
Vaccination
Vaccination - adverse effects
Vaccines
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Summary:When assessing the risks of a research protocol, review boards need to consider not only the possible harms but also the expected discomfort levels caused by the various study procedures. However, data on how children experience various study procedures are scarce. This study assessed perceived discomfort levels in 671 healthy children aged 0–2 years under­going vaccinations, venipunctures, and nasopharyngeal swab taking. In half of the study participants, venipunctures caused a moderate or high level of discomfort (49%). Corresponding figures for nasopharyngeal swabbing and vaccinations were 28% and 12%, respectively. Within the reported age group, increasing age was related with higher discomfort levels. In a majority of cases for all study procedures, the perceived levels of discomfort met the parents’ expectations.
ISSN:1556-2646
1556-2654
DOI:10.1525/jer.2013.8.3.66