Impact of Pre Operative Hypnosis on Anxiety in Children Aged 10 to 18 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Level of anxiety at day 1 (24 hours after surgery)
研究概览
简要总结
This study aims to find how hypnosis performed just before a painful surgery can change anxiety level, in children aged 10 to 18 years.
详细描述
Undergoing surgery can cause anxiety among children. Thus, peri operative anxiety can increase levels of pain, need for painkillers, and even length of stay in hospital.
Caring for children must take in account their anxiety. This anxiety can be treated through drugs or others means such as hypnosis. Thus, the use hypnosis in surgery has been very poorly assessed.
Parents will be given a consent form as well as an information note. This study aims to compare the level of post operative anxiety (D1)of children having hypnosis before receiving anaesthetics to the level of anxiety of children getting the usual care.
All the children included in this study will have a pre operative consultation with the Pain Management Nurse.
The study applies to inpatients, aged 10 to 18 years, who must go through orthopaedics surgery such as osteotomy (bone section) and spinal column surgery. 120 patients will be included in this study (60 in each arm) The primary outcome measure is the level of anxiety at day 1 (24 hours after surgery) Other outcome measure are
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 215 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 10-18 years
- •Orthopaedics surgery (spinal column, osteotomy)
- •ASA 1 & 2
排除标准
- •casualty surgery
- •patient or family unable to understand the study (language, disability ...)
- •patient or family refusing the study
结局指标
主要结局
Level of anxiety at day 1 (24 hours after surgery)
时间窗: 24 hours
Level anxiety will be measured 24 hours after exit of operating room, using A-VAS (Anxiety visual analog scale) by a single blind assessor.
次要结局
- Anxiety level(24 hours)
- Pain after surgery(24 hours)