Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child
CompletedNCT03149263
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- Official title
- Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child
- Conditions
- Cerebral Palsy
- Muscle Hypertonia
- Interventions
- Behavioral: distraction
- Sponsor
- University Hospital, Brest
- Start date
- 2015-11-10
- Primary completion
- 2017-03-20
- Sex
- All
- Age range
- from 2 Years to 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03149263