Objective: We investigated the impact of clown-care on pain in 45 children with cerebral palsy who underwent recurrent Botulinum-toxin injections (age 7.04± 4.68 years). Participants were randomized to receive either clown (n = 20) or standard (n = 25) -care. Methods: Pain Visual-Analogue-Scale (range 1-5) was reported before and after procedures. Pain assessment was lower for children undergoing Botulinum-toxin injections with clown-care (2.89± 1.36) compared to standard-care (3.85± 1.39; p = 0.036) even though pain anticipated prior to procedures was similar (∼3). Findings: Children who underwent the first procedure with clown-care reported lower pain even after they crossed-over to the following procedure which was standard (p = 0.048). Carryover effect was more prominent in injection-naïve children (p = 0.019) and during multiple procedures (p = 0.009). Prior pain experience correlated with pain in subsequent procedures only when first experience was standard-care (p = 0.001). Conclusions: Clown-care alleviated pain sensation during Botulinum-toxin injections and initial clown-care experience reduced pain during subsequent injections even though clowns were not present. Trial registration: clinicaltrials.gov ID # NCT01377883.
Bibliographical noteFunding Information:
Shaare Zedek Medical Center partially covered study expenses (HB, AC, YS, RLO). The second phase of this study (crossover) was funded by the Magi Foundation (HB 19003249), http://184.108.40.206/showpage-new.asp?Idnn=1489andnamef=Magi%20Foundationandotkuda=pass.aspandorder=submission-deadline,namefandview=. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Biostatistical Consulting (owned by the author LD) provided support in the form of salary for author LD but did not have any additional role in the study design, data collection, decision to publish, or preparation of the manuscript. The specific role of this author is articulated in the 'author contributions' section. We thank Yael Greenberg (RN) and the pediatric day care staff for daily assistance with a smile. We thank the children and parents for their trust and cooperation and consent to publish the pictures taken during the procedures.
© 2017 Ben-Pazi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.