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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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...)


Sponsor: University Hospital, Brest

Current Primary Outcome: Pain assessment by a hetero evaluator at the time of toxin injections [ Time Frame: 1 hour ]

Evaluation of the pain child during botulinum toxin with the FLACC (Face Legs Activity Cry Consolability) by a hetero evaluator


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluation of anxiety before the injections of botulinum toxins by the child and assessment by a accompanying person [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)


Original Secondary Outcome: Same as current

Information By: University Hospital, Brest

Dates:
Date Received: August 12, 2016
Date Started: November 10, 2015
Date Completion:
Last Updated: May 10, 2017
Last Verified: May 2017