Clown Care for Botulinum Toxin (BTX)

Not Applicable

Completed

• Conditions: Cerebral Palsy; Pain
• Interventions: Behavioral: clown care; Other: standard

• 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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Study First Submitted: 2011-06-19
• Study First Submitted QC: 2011-06-21
• Study First Posted: 2011-06-22
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-27
• Last Update Posted: 2018-12-31

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

Arm && Interventions

Group	Intervention	Description
clown care	clown care	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.
Standard intervention	standard	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.

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