Efficacy of Hypnoanalgesia by a Radiological Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- assessment of pain score by Visual Analog Scale (EVA)
研究概览
简要总结
This study highlights the global management of the various components of outpatient pain by hypnoanalgesia (pain management by hypnosis) in radiopediatrics.
Indeed, pain is induced by sclerosis of cutaneous angiomas in interventional radiology. It is managed by MEOPA (an equimolar mixture of oxygen nitrous oxide) or by general anesthesia.
For four years, the medical electroradiology technologist of the Mother and Child Hospital (HFME) of the Hospices Civils de Lyon offer patients in addition a pain management by hypnoanalgesia.
The investigator propose a multicenter open randomized study comparing two pain management strategies, in children aged 7 to 18 years treated for cutaneous angioma by sclerosis in interventional radiology at the HFME. The two strategies studied are: Hypnoanalgesia and MEOPA (the reference strategy).
The main objective is to evaluate the efficacy of hypnoanalgesia compared to the standard of care of pain, which is the use of MEOPA, in the treatment of sclerosis of cutaneous angioma in pediatric interventional radiology.
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
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child requiring a first treatment with sclerosis cutaneous angioma whose location allows treatment in interventional radiology room,
- •Child from 7 to 18 years old on the day of treatment,
- •Free and informed consent of the child and his parents (or legal representative),
- •Patient affiliated to a social security scheme
排除标准
- •Child under tutorship or guardianship,
- •Child suffering from severe psychotic disorders or under psychotropic drug treatment,
- •Child who has already had angioma sclerosis in the interventional radiology room. Indeed, the child can remember a previous support and have a priori, positive or negative, on the new support (memory bias),
- •Child not speaking French,
- •Deaf child or hearing impaired not allowing easy listening
研究组 & 干预措施
Hypnoanalgesia group
It is performed by a radiologist technologist who has been trained in Ericksonian hypnoanalgesia in the Hospices Civils de Lyon and has been practicing it regularly for 1 year.
干预措施: Hypnoanalgesia group (Other)
MEOPA Group
The pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA)
干预措施: Meopa Group (Other)
结局指标
主要结局
assessment of pain score by Visual Analog Scale (EVA)
时间窗: Day 0
Comparison of the pain score felt by the child during the procedure (score 0 or 1, absence or presence of pain, on an Analog Visual Scale (EVA)) between the MEOPA group and the hypnoanalgesia group.
次要结局
- Patient satisfaction assessed by a satisfaction questionary(Day 0)
- Pain assessed by Visual Analog Scale (EVA)(Day 0)
- MEOPA administration time(Day 0)
- anxiety assessed by Visual Analog Scale (EVA)(Day 0)
- Patient anxiety score assessed by anxiety Visual Analog Scale (EVA)(Day 0)
- number of side effects(Day 0)
- gravity of side effects(Day 0)
- number of injections performed per site(Day 0)