Clown-care reduces pain in children with cerebral palsy undergoing recurrent botulinum toxin injections- A quasi-randomized controlled crossover study

Abstract

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.

Conflict of interest statement

Competing Interests: We have the following interests. Lisa Deutsch is the owner of Biostatistical Consulting. Payment to BioStats for statistical analysis was covered by Magi Foundation. There are no patents, products in development or marketed products to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.

Figures

Fig 1. CONSORT flow diagram.

Study design process: enrollment, randomization, Allocation, follow-up and analysis.

Fig 2. Medical clowning effect before, during and after BTX injections.

Before: Clown engaging and distracting the anxious child who pays attention to the scene in front of him. During the injection: Clown and child in a secluded atmosphere at the other end of the table; parent watching with a smile. After: Child is laughing leaving the room empowered.

Fig 3. Pain (Visual Analogue Scale) after BTX injections with and without clown-care.

Box plots (diamond = mean, solid line in center = median) of pain after the first procedure according to the Visual Analogue Scale (VAS; range 1 = no pain to 5 = severe pain): After the procedure the pain was experienced as moderate for the clown group (black) and severe in controls (grey).

Fig 4. Carry over effect—Pain levels remained constant despite crossover (with/without clowning).

(A) Pain levels (VAS-after LSmean ±SE) remained stable in each group (grey solid line: clowning 1st-> standard 2nd; black dashed line: standard 1st-> clowning 2nd) and did not change between the first and second procedure. However, pain was lower for children who received clowning during the first injection (grey) compared to those who received clowning only on the second injection (black). (B) Anticipated pain (before) did not correlate with experienced pain (after) the first procedure for both groups. (C) However, pain experience (after) correlated with anticipated pain (before) of the second injection for those who received standard procedure in the first time (black) but not for those who previously received clowning (grey).

Fig 5. Pain as a function of clown presence during first procedure (longitudinal).

Pain levels (VAS-after LSmean ± SE) were lower for the children receiving clown care during the first injection (grey solid line) and remained low (VAS4) for children who did not receive clown care during the first injections.