Children's self reported discomforts as participants in clinical research

Staphorst, Mira S.; Hunfeld, J. A. M.; Vathorst, Suzanne van de; Passchier, Jan; Goudoever, Johannes B. van

doi:10.1016/j.socscimed.2015.08.019

Cited by 20 publications

(19 citation statements)

References 31 publications

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“…For this paper, we used a subsample of the interviews from an earlier study on children's discomforts in clinical research 11. We purposefully selected a broad range of children (in age and medical condition) undergoing various types of medical research procedures to assure a wide range of experiences, influences and attitudes 12.…”

Section: Methodsmentioning

confidence: 99%

Are positive experiences of children in non-therapeutic research justifiable research benefits?

2016

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Section: Methodsmentioning

confidence: 99%

Are positive experiences of children in non-therapeutic research justifiable research benefits?

2016

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“…Staphorst et al [8, 9] have conducted research in children with a mean age of 11.9 years and 10.6 years, respectively, evaluating experienced burden of participation in medical research and have provided information on how to reduce this burden. They reported corresponding results, showing two thirds of children willing to participate in a similar research study.…”

Section: Discussionmentioning

confidence: 99%

Young children experience little emotional burden during invasive procedures in asthma research

et al. 2018

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Research in children should strike the right balance between protecting underage study subjects and advancing the medical field. This study gives insight into the emotional burden that common invasive research procedures in asthma research have on young children, both from the child and parent perspective. Puppetry was used to stimulate children (age 5–6 years) to explain their emotional burden prior to and after the research procedures. We operationalised emotional burden as willingness to participate in future research and reluctance towards participation. Parents filled out a questionnaire on this topic. Symptomatic patients as well as healthy controls were analysed. Forty-one children were included. Children’s anticipatory fear for future research showed a clear decrease of 0.7 ± 1.6 on a 5-point Likert scale as a consequence of participation (p = 0.02). Sixty percent of all participating children explicitly indicated willingness to undergo identical research procedures again. Children uninformed by their parents about the venipuncture were significantly more reluctant to the venipuncture after the procedure (p < 0.01), compared to children who had been informed (4.0 ± 0.9 resp. 2.8 ± 1.2).Conclusion: This study suggests that the emotional burden of participation in asthma research for underage children can be prevented when they are properly informed and decreases as a consequence of participations. We believe increased emphasis should be placed on informing children and evaluating the emotional impact of research to help caretakers and research ethics committees make informed decisions about participation of children in medical research. What is Known: • Medical professionals and parents are likely to overestimate children’s discomfort undergoing (invasive) research procedures.• Two thirds of children (age 6–18 years) participating in medical research indicated that they would participate in the same research study again. What is New: • Pre-school children experience little emotional burden during invasive procedures in asthma research.• Proper communication about (invasive) research procedures in pre-school children helps to reduce the anticipatory fear of these procedures in the future.Electronic supplementary materialThe online version of this article (10.1007/s00431-018-3265-0) contains supplementary material, which is available to authorized users.

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“…Discomfort-which is mentioned as an important assessment criterion for research participation in most ethics guidelines and regulations-also involves other aspects than pain, distress and anxiety, as was shown in an interview study we conducted about the face-validity of discomfort from the child's perspective. 16 Measuring various forms of discomfort therefore provides a more thorough measure Skin prick test Children were tested for 20 allergens. A droplet of each allergen was placed on the inner forearm and penetrated through to the skin using a specially modified lancet.…”

Section: Discomfortmentioning

confidence: 99%

The child's perspective on discomfort during medical research procedures: a descriptive study

Staphorst

Benninga

Bisschoff³

et al. 2017

BMJ Open

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ObjectiveThe evaluation of discomfort in paediatric research is scarcely evidence-based. In this study, we make a start in describing children's self-reported discomfort during common medical research procedures and compare this with discomfort during dental check-ups which can be considered as a reference level of a ‘minimal discomfort’ medical procedure. We exploratory study whether there are associations between age, anxiety-proneness, gender, medical condition, previous experiences and discomfort. We also describe children's suggestions for reducing discomfort.DesignCross-sectional descriptive study.SettingPaediatric research at three academic hospitals.Patients357 children with and without illnesses (8–18 years, mean=10.6 years) were enrolled: 307 from paediatric research studies and 50 from dental care.Main outcome measuresWe measured various generic forms of discomfort (nervousness, annoyance, pain, fright, boredom, tiredness) due to six common research procedures: buccal swabs, MRI scans, pulmonary function tests, skin prick tests, ultrasound imaging and venepunctures.ResultsMost children reported limited discomfort during the research procedures (means: 1–2.6 on a scale from 1 to 5). Compared with dental check-ups, buccal swab tests, skin prick tests and ultrasound imaging were less discomforting, while MRI scans, venepunctures and pulmonary function tests caused a similar degree of discomfort. 60.3% of the children suggested providing distraction by showing movies to reduce discomfort. The exploratory analyses suggested a positive association between anxiety-proneness and discomfort.ConclusionsThe findings of this study support the acceptability of participation of children in the studied research procedures, which stimulates evidence-based research practice. Furthermore, the present study can be considered as a first step in providing benchmarks for discomfort of procedures in paediatric research.

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Children's self reported discomforts as participants in clinical research

Cited by 20 publications

References 31 publications

Are positive experiences of children in non-therapeutic research justifiable research benefits?

Are positive experiences of children in non-therapeutic research justifiable research benefits?

Young children experience little emotional burden during invasive procedures in asthma research

The child's perspective on discomfort during medical research procedures: a descriptive study

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