Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child (CLOWN-TOX)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Muscle Hypertonia; Cerebral Palsy

Treatments: Behavioral: distraction

Study type: Observational

Funder types: Other

Identifiers

NCT03149263

CLOWN-TOX

Details and patient eligibility

About

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

Full 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...)

Enrollment: 80 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Toxin-clown

Description:

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.

Treatment:

Behavioral: distraction

Toxin-usual distraction

Description:

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

Treatment:

Behavioral: distraction