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 discomfort levels in 671 healthy children aged 0-2 years under-going 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.
Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands. a.e.westra@lumc.nl
Anna E
AE
Westra
Elske J M
EJ
van Gils
Fenne
F
Aarts
Gerwin D
GD
Rodenburg
Reinier H
RH
Veenhoven
Eelko
E
Hak
Margreet
M
Scharloo
Ram N
RN
Sukhai
Jan M
JM
Wit
Inez
I
de Beaufort
Elisabeth Lieke A M
EL
Sanders
D000367:Age Factors; D035843:Biomedical Research / Q000941:ethics*; D002675:Child, Preschool; D006801:Humans; D007223:Infant; D010146:Pain / Q000209:etiology*; D010290:Parents; D010465:Perception; D018962:Phlebotomy / Q000009:adverse effects; D035842:Research Subjects; D013048:Specimen Handling / Q000009:adverse effects*; D014611:Vaccination / Q000009:adverse effects*