NCT01377883

Clown Care for Botulinum Toxin (BTX)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy
• Pain

Interventions

Type	Name	Description
OTHER	standard	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.
BEHAVIORAL	clown care	Cognitive coping Imagery Empowerment Reflecting emotions

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-05-01
• Completion: 2011-06-01
• First posted: 2011-06-22
• Last updated: 2018-12-31