Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2010-01-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
clown care
Cognitive coping Imagery Empowerment Reflecting emotions
Interventions
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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.
clown care
Cognitive coping Imagery Empowerment Reflecting emotions
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Autistic spectrum disorders (n =1)
* Severe anxiety requiring general anesthesia (n =1)
2 Years
18 Years
ALL
No
Sponsors
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Shaare Zedek Medical Center
OTHER
Responsible Party
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Dr. Hilla Ben-Pazi
PI
References
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Ben-Pazi H, Cohen A, Kroyzer N, Lotem-Ophir R, Shvili Y, Winter G, Deutsch L, Pollak Y. Clown-care reduces pain in children with cerebral palsy undergoing recurrent botulinum toxin injections- A quasi-randomized controlled crossover study. PLoS One. 2017 Apr 17;12(4):e0175028. doi: 10.1371/journal.pone.0175028. eCollection 2017.
Other Identifiers
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CL_BTX2011
Identifier Type: -
Identifier Source: org_study_id