Abstract

Botulinum toxin injections (BTI) in children often involve several sites of injections and repetitions of the procedure. Reducing pain and anxiety during this invasive procedure is a high priority but remains a challenge. The intervention of medical clowns for improving distraction during painful procedures is increasing and the question of their benefit during BTI raises. The aims of this study were to evaluate the effectiveness of medical clown presence on pain and anxiety during BTI compared to usual distraction procedures. Pain and anxiety of children between 1 and 18 years undergoing first or repetitive BIT at Brest University Hospital were evaluated. The presence of the clowns was randomized based on their availability. The usual distraction included individualized distraction, such as music, movies, discussion… Pain was evaluated using the Face Legs Activity Cry Consolability (FLACC) scale by an independent observer and using the Visual Analogic Scale (VAS) by the child and his parents. Anxiety before and during the BTI was evaluated using a VAS by the child and his parents. Proceeding of BTI was evaluated by the physician and child's parent, benefit of distraction was evaluated by child's parent, using a 4 point Likert scale. Eighty-eight children (56 males, mean age = 7.92 years, 453 injections), 42 children in the clown group and 46 in the usual distraction group were evaluated. The two groups were comparable on the main sample characteristics and in terms of procedures (Nitrous oxide, EMLA patch…). There were no significant between group differences on the FLACC and VAS anxiety. However, clown distraction was significantly better than usual distraction according to the parents. Subgroups analyses suggested that some children, like children with cognitive impairment may have a better benefit of the presence of clowns in terms of pain. The clown presence during BTI did not reduce significantly pain or anxiety in children compared to usual distraction. However, the presence of the clowns likely improves the level of distraction as evaluated by the parents, which is a key result for such a repetitive procedure. Some specific groups of children may have a better benefit of clown presence, which suggests other analyses to be performed and confirmed by future studies.

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