Clinical trial NCT03149263: Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child
Official title: Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Muscle Hypertonia
Keywords: botulinum toxin
anxiety reduction
pain reduction
medical clowns
distraction
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children receiving botulinum toxin in local pediatric day hospital

Brief summary: In children requiring botulinum toxin injections, improving supervisory procedures of injection sessions to reduce pain and improve the experience of this invasive procedure is needed. The intervention of medical clowns seems very interesting in this goal, but its effectiveness has not been proven within the botulinum toxin injections. The objective of the study is to evaluate in terms of profit the presence or absence of clowns during a session of botulinum toxins by determining their impact on pain and anxiety felt among children and their carers

Detailed description: In the literature, the presence of clowns allows a major reduction of pain and anxiety in children and their accompanying in various medical and hospital surgical settings. A previous study on a population of 60 children was conducted to assess the impact of the presence of clowns during the production of botulinum toxin injection in children but not confirming the benefit of their participation in carrying this medical procedure. The results of this study are opposed to current scientific data. Their impact clown assessment criteria seem however insufficient to actually support the conclusion as to the ineffectiveness of distractibility clowns in this specific medical procedure iterative injection of botulinum toxin.

The objective of the study is to evaluate the pain and anxiety before and after the botulinum toxin injection session in children and hetero-assessment of pain and anxiety by accompanying depending on the presence or not of clown. The second objectives are the evaluation of the course of the session by the injector doctor, the accompanying of the child and to evaluated the effect of distraction during the toxin of the clown or the usual distraction (music, movie...)

Eligibility criteria: Inclusion Criteria:

* Children aged 1 to 18 years
* Children with a neurogenic spasticity (cerebral palsy, spastic paraplegia, head trauma ...)
* Children with muscular pains orthopedic disorders (POPB, equino varus, ..)
* Botulinum Toxin Injection functional target, improvement in pain or amplitudes
* First injection or repeated injections of toxins
* No opposition formalized

Exclusion Criteria:

* Children between 0 and 1 year
* Opposition formalized to the data use

Primary outcomes:
measure: Pain assessment by a hetero evaluator at the time of toxin injections
timeFrame: 1 hour
Secondary outcomes:
measure: Evaluation of anxiety before the injections of botulinum toxins by the child and assessment by a accompanying person
timeFrame: 1 hour
measure: Evaluation of pain and anxiety after the botulinum toxin injection session in children and the accompanying person depending on the presence or not of clowns
timeFrame: 1 hour
measure: Evaluation of the course of the session of botulinum toxin by the injector doctor
timeFrame: 1 hour
measure: Evaluation of the course of the session of botulinum toxin by the accompanying person
timeFrame: 1 hour
measure: Evaluation of the effect of distraction during the session of botulinum toxin with the usual distraction (music, movie, ...) or the participation of the clown(s) distraction
timeFrame: 1 hour
Other outcomes:
Locations:
city: Brest
country: France
facility: Houx
Study officials:
affiliation: Physical Medical and Rehabilitation, CHRU Brest, France
name: Laetitia Houx, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vagnoli L, Caprilli S, Robiglio A, Messeri A. Clown doctors as a treatment for preoperative anxiety in children: a randomized, prospective study. Pediatrics. 2005 Oct;116(4):e563-7. doi: 10.1542/peds.2005-0466.
citation: Hansen LK, Kibaek M, Martinussen T, Kragh L, Hejl M. Effect of a clown's presence at botulinum toxin injections in children: a randomized, prospective study. J Pain Res. 2011;4:297-300. doi: 10.2147/JPR.S23199. Epub 2011 Sep 21.
citation: Molenaers G, Schorkhuber V, Fagard K, Van Campenhout A, De Cat J, Pauwels P, Ortibus E, De Cock P, Desloovere K. Long-term use of botulinum toxin type A in children with cerebral palsy: treatment consistency. Eur J Paediatr Neurol. 2009 Sep;13(5):421-9. doi: 10.1016/j.ejpn.2008.07.008. Epub 2008 Nov 1.
citation: Schroeder AS, Berweck S, Lee SH, Heinen F. Botulinum toxin treatment of children with cerebral palsy - a short review of different injection techniques. Neurotox Res. 2006 Apr;9(2-3):189-96. doi: 10.1007/BF03033938.
citation: Brochard S, Blajan V, Lempereur M, Le Moine P, Peudenier S, Lefranc J, Remy-Neris O. Effectiveness of nitrous oxide and analgesic cream (lidocaine and prilocaine) for prevention of pain during intramuscular botulinum toxin injections in children. Ann Phys Rehabil Med. 2009 Dec;52(10):704-16. doi: 10.1016/j.rehab.2009.09.001. Epub 2009 Oct 6.
citation: Bayon-Mottu M, Gambart G, Deries X, Tessiot C, Richard I, Dinomais M. Pain during injections of botulinum toxin in children: Influence of the localization technique. Ann Phys Rehabil Med. 2014 Dec;57(9-10):578-86. doi: 10.1016/j.rehab.2014.09.010. Epub 2014 Oct 8.
citation: Houx L, Dubois A, Brochard S, Pons C. Do clowns attenuate pain and anxiety undergoing botulinum toxin injections in children? Ann Phys Rehabil Med. 2020 Oct;63(5):393-399. doi: 10.1016/j.rehab.2018.12.004. Epub 2019 Jan 29.