Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain assessment by a hetero evaluator at the time of toxin injections
研究概览
简要总结
In children requiring botulinum toxin injections, improving supervisory procedures of injection sessions to reduce pain and improve the experience of this invasive procedure is needed. The intervention of medical clowns seems very interesting in this goal, but its effectiveness has not been proven within the botulinum toxin injections. The objective of the study is to evaluate in terms of profit the presence or absence of clowns during a session of botulinum toxins by determining their impact on pain and anxiety felt among children and their carers
详细描述
In the literature, the presence of clowns allows a major reduction of pain and anxiety in children and their accompanying in various medical and hospital surgical settings. A previous study on a population of 60 children was conducted to assess the impact of the presence of clowns during the production of botulinum toxin injection in children but not confirming the benefit of their participation in carrying this medical procedure. The results of this study are opposed to current scientific data. Their impact clown assessment criteria seem however insufficient to actually support the conclusion as to the ineffectiveness of distractibility clowns in this specific medical procedure iterative injection of botulinum toxin.
The objective of the study is to evaluate the pain and anxiety before and after the botulinum toxin injection session in children and hetero-assessment of pain and anxiety by accompanying depending on the presence or not of clown. The second objectives are the evaluation of the course of the session by the injector doctor, the accompanying of the child and to evaluated the effect of distraction during the toxin of the clown or the usual distraction (music, movie...)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- 是
入选标准
- •Children aged 1 to 18 years
- •Children with a neurogenic spasticity (cerebral palsy, spastic paraplegia, head trauma ...)
- •Children with muscular pains orthopedic disorders (POPB, equino varus, ..)
- •Botulinum Toxin Injection functional target, improvement in pain or amplitudes
- •First injection or repeated injections of toxins
- •No opposition formalized
排除标准
- •Children between 0 and 1 year
- •Opposition formalized to the data use
结局指标
主要结局
Pain assessment by a hetero evaluator at the time of toxin injections
时间窗: 1 hour
Evaluation of the pain child during botulinum toxin with the FLACC (Face Legs Activity Cry Consolability) by a hetero evaluator
次要结局
- Evaluation of the course of the session of botulinum toxin by the injector doctor(1 hour)
- Evaluation of anxiety before the injections of botulinum toxins by the child and assessment by a accompanying person(1 hour)
- Evaluation of pain and anxiety after the botulinum toxin injection session in children and the accompanying person depending on the presence or not of clowns(1 hour)
- Evaluation of the effect of distraction during the session of botulinum toxin with the usual distraction (music, movie, ...) or the participation of the clown(s) distraction(1 hour)
- Evaluation of the course of the session of botulinum toxin by the accompanying person(1 hour)