Clown Care for Botulinum Toxin (BTX)

Shaare Zedek Medical Center

Status: Completed

Conditions: Cerebral Palsy; Pain

Treatments: Behavioral: clown care; Other: standard

Study type: Interventional

Funder types: Other

Identifiers

NCT01377883

CL_BTX2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Standard intervention

Sham Comparator group

Description:

Preparation and information: the doctor and nurse explained the steps of the 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. Memory change and positive reinforcement: medical staff present spoke to the child positively and offered prizes, among which the child could choose. Volunteer attendance: as part of the control session, receiving no particular instructions in relation to the child's potential pain during the procedure.

Treatment:

Other: standard

clown care

Experimental group

Description:

Cognitive coping: encouraging a child to cope with the challenge. Imagery: a cognitive technique used to encourage the child to cope with the pain and distress of the procedure by imagining a pleasant object or experience Empowerment: the child is made to feel empowered by controlling the actions of the clown Reflecting emotions: the clown, sensing the state of the child, plays it out in an exaggerated fashion.

Treatment:

Behavioral: clown care