Clown Care for Botulinum Toxin (BTX)
- Conditions
- Cerebral PalsyPain
- Registration Number
- NCT01377883
- Lead Sponsor
- Shaare Zedek Medical Center
- Brief Summary
Children with cerebral palsy (CP) undergo multiple painful procedures such as Botulinum toxin (BTX) injections that are administered several times a year. While clown care reduces preoperative anxiety, its effect on painful procedures has not been assessed. We hypothesized that medical clowning reduces pain and anxiety during BTX injections.
- Detailed Description
PATIENTS AND METHODS: Twenty five children with CP (mean age 7.4±4.8 years; 19 boys), enrolled in this randomized controlled study underwent BTX injections (3±1.7 muscles per procedure). Prior to treatment each child was assigned to receive either medical clown intervention (study) or standard care (control). Outcome measure was the Visual Analogue Scale (VAS) as reported by the child (n =14) or parent (n =11) prior and subsequent to each procedure.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Children with CP for whom BTX treatment was indicated
- Children with minimal communication skills (n =1)
- Autistic spectrum disorders (n =1)
- Severe anxiety requiring general anesthesia (n =1)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Visual Analogue Scale sevral minutes before and after BTX injections Visual Analogue Scale by the child before after BTX injection. Parent rated the pain if the child was younger than 5 years or cognitively impaired
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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