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

NCT03149263 | Completed

• 1 other identifier: CLOWN-TOX
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebral Palsy; Muscle Hypertonia

Keywords

botulinum toxin; anxiety reduction; pain reduction; medical clowns; distraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evaluation of anxiety before the injections of botulinum toxins by the child and assessment by a accompanying person

  1 hour

• 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

  1 hour

• Evaluation of the course of the session of botulinum toxin by the injector doctor

  1 hour

• Evaluation of the course of the session of botulinum toxin by the accompanying person

  1 hour

• 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

  1 hour

Study Arms (2)

Toxin-clown

Botulinum toxin injections are carried out according to the usual injection protocol. 40 children will be included into the arm toxin with clown distraction. During injections, clowns take information with the doctor before the procedure on the child's pathology, the cognitive level, the number of injections. During injections, clowns fit and distraction can change depending on the reaction of the child to their intervention.

Behavioral: distraction

Toxin-usual distraction

40 children will be included into the arm "toxin with usual distraction" The usual distraction involves discussion with the child, and its accompanying its interests, to define the use of music, songs, television, video games or other distraction during the session. If the first distraction doesn't work, it's possible to switch to another distraction during injections

Behavioral: distraction

Interventions

distraction BEHAVIORAL

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, ...)

Toxin-clown; Toxin-usual distraction

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children receiving botulinum toxin in local pediatric day hospital

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Houx

Brest, 29609, France

Location

Related Publications (7)

• 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.

  PMID: 16199685 BACKGROUND

• 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.

  PMID: 22003302 BACKGROUND

• 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.

  PMID: 18977158 RESULT

• 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.

  PMID: 16785117 RESULT

• 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.

  PMID: 19854692 RESULT

• 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.

  PMID: 25454692 RESULT

• 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.

  PMID: 30708069 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Muscle Hypertonia

Interventions

Osteogenesis, Distraction

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bone Lengthening; Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Laetitia Houx, MD

  Physical Medical and Rehabilitation, CHRU Brest, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: May 11, 2017
• Study Start: November 10, 2015
• Primary Completion: March 20, 2017
• Study Completion: March 20, 2017
• Last Updated: May 11, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)