Feasibility of Implementing Yoga and Meditation in the Preoperative Period of Pediatric Idiopathic Scoliosis Surgery, an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage of patients with observance greater than or equal to 2
研究概览
简要总结
This study has to purpose Yoga and Meditation before surgery for idiopathic scoliosis.
Protocol's observance will tell the investigators if it is feasible and appropriate in a University hospital center.
详细描述
Adolescent idiopathic scoliosis is the most common deforming orthopedic condition.
Preoperative anxiety is increased by operating time, post-operative pain level, neurological and hemorrhagic risk.
The aim of the study was to purpose five sessions of Yoga and Meditation before surgery, remotely and face-to-face.
Observance of the 5 sessions will tell us if this protocol is feasible and appropriate. Preoperative anxiety intensity will also be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 8 to 17 years
- •Female and male gender
- •Planned idiopathic scoliosis surgery
排除标准
- •Physical inability to do simple yoga postures during the initial session
- •Neurological spinal deformity (cerebral palsy, severe epileptic disease, myopathy)
- •Misunderstanding of the french language
- •Recent history of characterized depressive episode: hospitalization and/or antidepressant treatment in the last 6 months
- •Time between the first YOMEPOP session and the date of the operation less than 28 days
- •Refusal of permission to take picture
- •Failure to obtain informed consent from one of the parents with parental authority
- •Absence of affiliation to a French social security scheme or beneficiary of such a scheme
- •Patient with a legal protection measure
结局指标
主要结局
Percentage of patients with observance greater than or equal to 2
时间窗: During the preoperative period
Yoga and Meditation protocol's observance will be rated from 0 to 3 (0 is a session not completed to 3 is a fully completed session)
次要结局
- FPS-R scores(From preoperative period up to 1 day postoperative)
- Assessment of satisfaction of Yoga and Meditation protocol(The day before the surgery)
- VAS-anxiety scores(From preoperative period up to 1 day postoperative)