title: Children's self reported discomforts as participants in clinical research.
abstract: BACKGROUND
  There is little empirical evidence on children's subjective experiences of discomfort during clinical research procedures. Therefore, Institutional Review Boards have limited empirical information to guide their decision-making on discomforts for children in clinical research. To get more insight into what children's discomforts are during clinical research procedures, we interviewed a group of children on this topic and also asked for suggestions to reduce possible discomforts.
  
  
  METHODS
  Forty-six children (aged 6-18) participating in clinical research studies (including needle-related procedures, food provocation tests, MRI scans, pulmonary function tests, questionnaires) were interviewed about their experiences during the research procedures. Thematic analysis was used to analyze the interviews.
  
  
  RESULTS
  The discomforts of the interviewed children could be divided into two main groups: physical and mental discomforts. The majority experienced physical discomforts during the research procedures: pain, shortness of breath, nausea, itchiness, and feeling hungry, which were often caused by needle procedures, some pulmonary procedures, and food provocation tests. Mental discomforts included anxiousness because of anticipated pain and not knowing what to expect from a research procedure, boredom and tiredness during lengthy research procedures and waiting, and embarrassment during Tanner staging. Children's suggestions to reduce the discomforts of the research procedures were providing distraction (e.g. watching a movie or listening to music), providing age-appropriate information and shortening the duration of lengthy procedures.
  
  
  CONCLUSIONS
  Our study shows that children can experience various discomforts during research procedures, and it provides information about how these discomforts can be reduced according to them. Further research is needed with larger samples to study the number of children that experience these mentioned discomforts during research procedures in a quantitative way.
authors: Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus University Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands. Electronic address: m.staphorst@erasmusmc.nl.
authors: Mira S
authors: MS
authors: Staphorst
authors: Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus University Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands. Electronic address: j.hunfeld@erasmusmc.nl.
authors: Joke A M
authors: JA
authors: Hunfeld
authors: Department of Medical Ethics and Public Health, Erasmus University Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands. Electronic address: s.vandevathorst@erasmusmc.nl.
authors: Suzanne
authors: S
authors: van de Vathorst
authors: Department of Clinical Psychology, EMGO+, VU University, Van der Boechorststraat 1, 1081 BT, Amsterdam, The Netherlands. Electronic address: j.passchier@vu.nl.
authors: Jan
authors: J
authors: Passchier
authors: Department of Pediatrics, VU University Medical Center (VUmc), PO Box 7057, 1007 MB, Amsterdam, The Netherlands; Department of Pediatrics, Emma Children's Hospital, Academic Medical Center (AMC), PO Box 22660, 1100 DD, Amsterdam, The Netherlands. Electronic address: h.vangoudoever@vumc.nl.
authors: Johannes B
authors: JB
authors: van Goudoever
mesh_terms: D000293:Adolescent; D001007:Anxiety; D001294:Attitude to Health; D035843:Biomedical Research; D001887:Boredom; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D058748:Pain Perception / Q000502:physiology*; D036301:Qualitative Research; D057566:Self Report; D011795:Surveys and Questionnaires; D013997:Time Factors
keywords: Adolescent; Child; Clinical research procedures; Discomfort; Ethics; Experience; Self-report