Clown Care for Botulinum Toxin (BTX)

This study has been completed.
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01377883
First received: June 19, 2011
Last updated: June 21, 2011
Last verified: June 2011

June 19, 2011
June 21, 2011
January 2010
May 2011   (final data collection date for primary outcome measure)
Visual Analogue Scale [ Time Frame: sevral minutes before and after BTX injections ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01377883 on ClinicalTrials.gov Archive Site
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Clown Care for Botulinum Toxin (BTX)
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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.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cerebral Palsy
  • Pain
  • 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
  • Sham Comparator: Standard intervention

    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.

    Intervention: Other: standard
  • Experimental: 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.
    Intervention: Behavioral: clown care
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
June 2011
May 2011   (final data collection date for primary outcome measure)

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)
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT01377883
CL_BTX2011
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Hilla Ben Pazi, Shaare Zedek Medical Center
Shaare Zedek Medical Center
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Shaare Zedek Medical Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP