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

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT03149263

Collaborator

(none)

Enrollment

Location

16.3

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy Muscle Hypertonia	Behavioral: distraction

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...)

Study Design

Study Type:

Observational

Actual Enrollment :

80 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 10, 2015

Actual Primary Completion Date :

Mar 20, 2017

Actual Study Completion Date :

Mar 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
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 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-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 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, ...)

Arm

Intervention/Treatment

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

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-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

Outcome Measures

Primary Outcome Measures

Pain assessment by a hetero evaluator at the time of toxin injections [1 hour]
Evaluation of the pain child during botulinum toxin with the FLACC (Face Legs Activity Cry Consolability) by a hetero evaluator

Secondary Outcome Measures

Evaluation of anxiety before the injections of botulinum toxins by the child and assessment by a accompanying person [1 hour]
evaluation of the anxiety before the botulinum toxin by the use of a VAS anxiety scale for the children and their accompanying person
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 anxiety after the botulinum toxin by the use of a VAS anxiety scale for the children and their accompanying person
Evaluation of the course of the session of botulinum toxin by the injector doctor [1 hour]
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)
Evaluation of the course of the session of botulinum toxin by the accompanying person [1 hour]
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)
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]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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