Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child

Cerebral Palsy Clinical Trial

— CLOWN-TOX  

Official title:

Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03149263
• Other study ID #: CLOWN-TOX
• Status: Completed
• Phase: N/A
• First received: August 12, 2016
• Last updated: May 10, 2017
• Start date: November 10, 2015
• Est. completion date: March 20, 2017

Study information

• Verified date: May 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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...)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 20, 2017
• Est. primary completion date: March 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Hypertonia

Intervention

Behavioral:
• distraction
Children will all benefit toxin injections with the same protocol. Only the distraction will be different during the session: either the children will have a distraction realized by the team of clowns / or children will benefit a classic distraction (TV, music, ...)

Locations

Country	Name	City	State
France	Houx	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (6)

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 20 — View Citation

Brochard S, Blajan V, Lempereur M, Le Moine P, Peudenier S, Lefranc J, Rémy-Néris O. Effectiveness of nitrous oxide and analgesic cream (lidocaine and prilocaine) for prevention of pain during intramuscular botulinum toxin injections in children. Ann Phys — View 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. — View Citation

Molenaers G, Schörkhuber 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. d — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment by a hetero evaluator at the time of toxin injections	Evaluation of the pain child during botulinum toxin with the FLACC (Face Legs Activity Cry Consolability) by a hetero evaluator	1 hour
Secondary	Evaluation of anxiety before the injections of botulinum toxins by the child and assessment by a accompanying person	evaluation of the anxiety before the botulinum toxin by the use of a VAS anxiety scale for the children and their accompanying person	1 hour
Secondary	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	evaluation of the anxiety after the botulinum toxin by the use of a VAS anxiety scale for the children and their accompanying person	1 hour
Secondary	Evaluation of the course of the session of botulinum toxin by the injector doctor	Evaluation of the progress of the botulinum toxins session by the injector doctor on a scale of 0-4 (0 bad conduct and 4 very smooth conduct of the session)	1 hour
Secondary	Evaluation of the course of the session of botulinum toxin by the accompanying person	Evaluation of the progress of the botulinum toxins session by the accompanying person on a scale of 0-4 (0 bad conduct and 4 very smooth conduct of the session)	1 hour
Secondary	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	Evaluation of the effect of distraction establishment on a scale of 0 to 4 estimated in the accompanying person (0 bad conduct and 4 very smooth conduct of the session)	1 hour