Clown Care for Botulinum Toxin (BTX)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with CP for whom BTX treatment was indicated
排除标准
- •Children with minimal communication skills (n =1)
- •Autistic spectrum disorders (n =1)
- •Severe anxiety requiring general anesthesia (n =1)
研究组 & 干预措施
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.
干预措施: standard (Other)
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.
干预措施: clown care (Behavioral)
结局指标
主要结局
Visual Analogue Scale
时间窗: 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
次要结局
未报告次要终点
研究者
Dr. Hilla Ben-Pazi
PI
Shaare Zedek Medical Center