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Clown Care for Botulinum Toxin (BTX)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01377883
Enrollment
25
Registered
2011-06-22
Start date
2010-01-31
Completion date
2011-06-30
Last updated
2018-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Pain

Keywords

Needle, Anxiety, Pain, Clowns

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.

Interventions

OTHERstandard

Preparation and information regarding the BTX procedure: placing EMG electrodes, wiping the area with an alcohol swab, cooling with ethyl chloride, needle insertion into the muscle and the importance of EMG noise. Injection performed under EMG guidance. Two sites of injection per muscle were used to enhance diffusion. The child could often see the procedure when the upper limb was treated but not during lower limb injections. Memory change and positive reinforcement: Following the BTX injection, the medical staff present spoke to the child positively and offered prizes Volunteer attendance: In the daycare unit there are young volunteers routinely present, assisting with technical aspects of the procedure.

BEHAVIORALclown care

Cognitive coping Imagery Empowerment Reflecting emotions

Sponsors

Shaare Zedek Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scalesevral minutes before and after BTX injectionsVisual Analogue Scale by the child before after BTX injection. Parent rated the pain if the child was younger than 5 years or cognitively impaired

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026