Study of a Therapy Without Drugs, Supplementary to an Usual Treatment for the Pains Caused by Removing the Redon's Drain From a 7 to 17 Years Old Child in Pediatric Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- To compare the score of pain, just after the removal of the Redon's drain
研究概览
简要总结
The 3rd governmental plan of fighting against the pain favored the development and the evaluation of the efficiency of the non pharmacological methods. Its results always showes a lack of knowledge of these methods and the utility to pursue the researches.
In the department of pediatric surgery of the university hospital of Limoges, the relaxing-touch is one of these methods which is more and more used. The healthcare staff noticed the beneficial effects of such an empirical method in terms of comfort and quality of life for the children.
In 2011, a pilot study led in this department showed that, in spite of the usual treatment, the removal of the Redon's drain remains painful for 25 % of the children (score on the pain scale > or = 4). This result convinced the medical team to write a protocol of research from the following hypothesis: the implementation of a protocol of the Redon's drain removal associated to the relaxing touch and usual treatment could lead to a decrease of the acute pain for a 7 to 17 years old child.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children > or = 7 and < 18 years old
- •Hospitalization for surgery having required the settle of a Redon's drain during surgery.
- •The presence of at least one of the legal representatives with the child during the care.
- •The consent of at least one of the legal representatives and agreement of the child for the relaxing-touch method.
- •The affiliation of one of the legal guardian to the social security.
排除标准
- •Children with an intellectual deficiency preventing the use of the scale EVA from the pain.
- •Children having already had one or several removal of the Redon's drain: the negative memory of the pain for a similar act could falsify the score of pain
- •Children refusing the usual care of the pain in the department by the MEOPA.
研究组 & 干预措施
Relaxing-touch method
干预措施: Relaxing-touch method (Other)
Usual care
结局指标
主要结局
To compare the score of pain, just after the removal of the Redon's drain
时间窗: 5 minutes
The score of pain, just after the removal of the Redon's drain, constitutes the main end point. It will be collected by the score of the EVA (scores from 0 to 10)
次要结局
- Proportion of children with a pain level ≥ 4 during removal of the drain(5 minutes)
- Percentage of children with a pain rating ≥ 4(5 minutes)
- To compare, for 2 groups, the Score of pain: EVA scale (score 0-10).(5 minutes)
- To compare, for 2 groups, the average level of EVA-anxiety scores(5 minutes)