Clown Care for Botulinum Toxin (BTX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01377883|
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : December 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy Pain||Other: standard Behavioral: clown care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||June 2011|
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.
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
- 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