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

NCT03149263 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2017-05-11

No results posted yet for this study

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

Interventions

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, ...)

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Principal Investigators

  • Laetitia Houx, MD · Physical Medical and Rehabilitation, CHRU Brest, France

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-10
Primary Completion
2017-03-20
Completion
2017-03-20

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03149263 on ClinicalTrials.gov