Study on the Benefit of the Intervention of Clowns in Pediatric Oncology in the Accompaniment of Painful Acts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Change of Pain score of the patient Self Assessment Scale (VAS)
研究概览
简要总结
The diagnosis and treatment of childhood cancer involves frequent and repeated painful acts. The pediatric oncology-hematology service of Nancy's hospital innovates thanks to the involvement of clowns in the hospital. The effects of the clown's intervention corroborate the results of studies which demonstrate that when painful complaints are increased by an empathetic attitude, they are reduced by half when the child is distracted.
The main objective is to assess the impact of the presence or absence of clowns during the performance of a painful act, on pain, in children who have benefited from this act. no clowns during the performance of a painful act, on anxiety, in children who have benefited from this act.
The secondary objectives are:
- Evaluate the impact of the presence or not of clowns during the performance of a painful act, on the anxiety of the parents of the child who benefited from this act.
- Measure the perception and acceptance of the healthcare team of the presence of clowns 1 time every 3 months.
- Measure the clowns' perception of their interaction with the child, the parents and the healthcare team once every 3 months.
- Evaluate the overall impact of the clown intervention during the performance of a painful act in children on the course of the act by a "neutral" person (health manager) once every 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child virgin with experience for targeted acts during the 1st painful act or child undergoing follow-up provided that he is virgin with experience of the presence of clowns during these acts.
- •Child with cancer
- •Child requiring a painful act among the following 3 acts: lumbar puncture, myelogram, needle placement in an implantable chamber
- •Parental authority holder (s) who have received full information on the organization of the research and who have given their written consent for the participation of their child
- •Personal adhesion of the child with a view to his participation
- •Presence of at least one of the two parents during act 1
- •Availability of the duo of clowns for the realization of act n ° 1 if the group assigned is the group Clowns-Sans Clowns
排除标准
- •Parents / child's refusal of clowns to intervene
结局指标
主要结局
Change of Pain score of the patient Self Assessment Scale (VAS)
时间窗: inclusion, up to 2 years
The scale is between 0 to 100
次要结局
- Anxiety score of the patient with modified-Yale Preoperative Anxiety Scale (m-YPAS)(up to 8 weeks after inclusion)
- Usual Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-B)(up to 8 weeks after inclusion)
- Change of Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-A)(up to 8 weeks after inclusion)
- Score of perception and acceptance of the presence of clowns with the healthcare team Questionnaire(through completion of the study, an average of 2 years)
- Perception score of interactions with the child, parents and the team with clowns Questionnaire(through completion of the study, an average of 2 years)
- Score of evaluation of the overall impact of the presence or not of a clown Questionnaire(through completion of the study, an average of 2 years)
研究者
Madame Valérie GAÜZES
Principal Investigator
Central Hospital, Nancy, France