Staphorst Mira S, Benninga Marc A, Bisschoff Margriet, Bon Irma, Busschbach Jan J V, Diederen Kay, van Goudoever Johannes B, Haarman Eric G, Hunfeld Joke A M, Jaddoe Vincent V W, de Jong Karin J M, de Jongste Johan C, Kindermann Angelika, Königs Marsh, Oosterlaan Jaap, Passchier Jan, Pijnenburg Mariëlle W, Reneman Liesbeth, Ridder Lissy de, Tamminga Hyke G, Tiemeier Henning W, Timman Reinier, van de Vathorst Suzanne
Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus University Medical Centre, Rotterdam, The Netherlands.
Department of Paediatrics, Emma Children's Hospital, Academic Medical Center (AMC), Amsterdam, The Netherlands.
BMJ Open. 2017 Aug 1;7(7):e016077. doi: 10.1136/bmjopen-2017-016077.
The 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.
Cross-sectional descriptive study.
Paediatric research at three academic hospitals.
357 children with and without illnesses (8-18 years, mean=10.6 years) were enrolled: 307 from paediatric research studies and 50 from dental care.
We 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.
Most 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.
The 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.
儿科研究中对不适的评估几乎没有循证依据。在本研究中，我们着手描述儿童在常见医学研究程序中自我报告的不适情况，并将其与牙科检查时的不适进行比较，牙科检查可被视为“最小不适”医学程序的参考水平。我们探索性研究年龄、焦虑倾向、性别、健康状况、既往经历与不适之间是否存在关联。我们还描述了儿童对减轻不适的建议。
横断面描述性研究。
三家学术医院的儿科研究。
招募了357名患病和未患病的儿童（8 - 18岁，平均 = 10.6岁）：307名来自儿科研究项目，50名来自牙科护理。
我们测量了六种常见研究程序（颊拭子采样、磁共振成像扫描、肺功能测试、皮肤点刺试验、超声成像和静脉穿刺）导致的各种一般形式的不适（紧张、烦恼、疼痛、恐惧、无聊、疲倦）。
大多数儿童报告在研究程序中不适程度有限（评分：1至5分，平均为1 - 2.6分）。与牙科检查相比，颊拭子试验、皮肤点刺试验和超声成像带来的不适较少，而磁共振成像扫描、静脉穿刺和肺功能测试引起的不适程度相似。60.3%的儿童建议通过播放电影来分散注意力以减轻不适。探索性分析表明焦虑倾向与不适之间存在正相关。
本研究结果支持儿童参与所研究的研究程序的可接受性，这促进了循证研究实践。此外，本研究可被视为为儿科研究程序的不适提供基准的第一步。
