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Clown Care for Botulinum Toxin (BTX)

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ClinicalTrials.gov Identifier: NCT01377883
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : June 22, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Cerebral Palsy Pain Other: standard Behavioral: clown care

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2010
Primary Completion Date : May 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

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.

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.
Behavioral: clown care
Cognitive coping Imagery Empowerment Reflecting emotions


Outcome Measures

Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 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


Eligibility Criteria

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hilla Ben Pazi, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01377883     History of Changes
Other Study ID Numbers: CL_BTX2011
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

Keywords provided by Shaare Zedek Medical Center:
Needle, Anxiety, Pain, Clowns

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ethyl Chloride
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents