MedPath

Clown Care for Botulinum Toxin (BTX)

Not Applicable
Completed
Conditions
Cerebral Palsy
Pain
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
Inclusion Criteria
  • Children with CP for whom BTX treatment was indicated
Exclusion Criteria
  • 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
NameTimeMethod
Visual Analogue Scalesevral 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
NameTimeMethod

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