TY - JOUR
T1 - Perceived discomfort levels in healthy children participating in vaccine research
AU - Westra, Anna E.
AU - Van Gils, Elske J M
AU - Aarts, Fenne
AU - Rodenburg, Gerwin D.
AU - Veenhoven, Reinier H.
AU - Hak, Eelko
AU - Scharloo, Margreet
AU - Sukhai, Ram N.
AU - Wit, Jan M.
AU - De Beaufort, Inez
AU - Sanders, Elisabeth A M
PY - 2013/7/1
Y1 - 2013/7/1
N2 - 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.
AB - 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.
KW - Children
KW - Ethics
KW - Research subjects
KW - Review board
KW - Risk assessment
KW - Vaccines
UR - http://www.scopus.com/inward/record.url?scp=84881512010&partnerID=8YFLogxK
U2 - 10.1525/jer.2013.8.3.66
DO - 10.1525/jer.2013.8.3.66
M3 - Article
AN - SCOPUS:84881512010
SN - 1556-2646
VL - 8
SP - 66
EP - 72
JO - Journal of Empirical Research on Human Research Ethics
JF - Journal of Empirical Research on Human Research Ethics
IS - 3
ER -