Houx Laetitia, Dubois Amandine, Brochard Sylvain, Pons Christelle
Department of physical and medical rehabilitation, CHRU MORVAN, 29602 Brest, Bretagne, France; Department of pediatric physical and medical rehabilitation, fondation ILDYS, 29200 Brest, Bretagne, France; Laboratory of medical information processing, Inserm U1101, 29200 Brest, Bretagne, France.
Department of psychology, university of occidental Brittany, 29200 Brest, Bretagne, France; LP3C, EA 1285, Rennes 2, 35000 Rennes, Bretagne, France.
Ann Phys Rehabil Med. 2020 Oct;63(5):393-399. doi: 10.1016/j.rehab.2018.12.004. Epub 2019 Jan 29.
Botulinum toxin injection (BTI) is the primary treatment for spasticity in children. Anxiety and pain are important concerns to address to attenuate the discomfort of BTI. The aim of this study was to compare the effectiveness of medical clowns and usual distractions, both added to nitrous oxide (NO) and analgesic cream, on pain and anxiety during BTI sessions in children.
The primary outcome was pain evaluated by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. Secondary criteria were pain rated on a Visual Analog Scale (VAS) by the child and parent, anxiety rated on a VAS before and during BTIs by the child and parent(s), rating of the success of the sessions on a 4-point Likert scale by the physician and parent(s), and rating of the benefits of the distraction by the parent(s). Non-parametric tests were used for between-group comparisons.
Baseline group characteristics of the clown and control groups did not differ. During 88 BTI sessions (40 with clown distraction and 48 with control distraction) in 59 children (35 boys; 52 with cerebral palsy, 12 with moderate to severe cognitive disorders), median maximal FLACC score was 2.5 (interquartile range [IQR]: 1-4) in the clown group and 3 (IQR: 1-4.3) in the control group. VAS self-reported pain score was 2.5 (IQR: 0-5) and 3 (IQR: 1-6.3) in the clown and control groups (P=0.56), and VAS proxy-reported pain score was 2.5 (IQR: 0.3-3.4) and 3 (IQR: 1-4.5) (P=0.25). After BTI sessions, the 2 groups did not differ in VAS self- and proxy-reported anxiety (P=0.83 and P=0.81). Physician and parent ratings of the success of sessions were similar between the groups (P=0.89 and P=0.11). Parent ratings of the perceived benefits of distraction were higher in the clown than control group (P=0.004).
Although clown distraction was particularly appreciated by parents, it did not significantly reduce pain or anxiety in children as compared with usual distraction.
ClinicalTrials.gov ID: NCT03149263.
肉毒毒素注射（BTI）是治疗儿童痉挛的主要方法。焦虑和疼痛是减轻BTI不适需要解决的重要问题。本研究的目的是比较在儿童BTI治疗期间，在一氧化二氮（NO）和镇痛乳膏基础上增加医疗小丑干预和常规分心干预对疼痛和焦虑的影响。
主要结局指标是通过面部、腿部、活动、哭闹、安慰度（FLACC）量表评估的疼痛。次要标准包括儿童和家长通过视觉模拟量表（VAS）对疼痛的评分、儿童和家长在BTI治疗前及治疗期间通过VAS对焦虑的评分、医生和家长通过4分量表对治疗成功程度的评分，以及家长对分心干预效果的评分。采用非参数检验进行组间比较。
小丑组和对照组的基线组特征无差异。在59名儿童（35名男孩；52名患有脑瘫，12名患有中度至重度认知障碍）的88次BTI治疗中（40次采用小丑分心干预，48次采用对照分心干预），小丑组的FLACC最高中位数评分为2.5（四分位间距[IQR]：1 - 4），对照组为3（IQR：1 - 4.3）。小丑组和对照组的VAS自我报告疼痛评分分别为2.5（IQR：0 - 5）和3（IQR：1 - 6.3）（P = 0.56），VAS代理报告疼痛评分分别为2.5（IQR：0.3 - 3.4）和3（IQR：1 - 4.5）（P = 0.25）。BTI治疗后，两组在VAS自我报告和代理报告的焦虑方面无差异（P = 0.83和P = 0.81）。医生和家长对治疗成功程度的评分在两组间相似（P = 0.89和P = 0.11）。家长对小丑分心干预效果的评分高于对照组（P = 0.004）。
尽管小丑分心干预特别受家长欢迎，但与常规分心干预相比，它并未显著减轻儿童的疼痛或焦虑。
ClinicalTrials.gov标识符：NCT03149263。
