A Single Mindfulness Meditation Session in Preoperative Anxiety : Effects on the Autonomous Nervous System
Anxiety is an emotional disorder. It's a painful concern caused by uncertainty. It is a complex phenomenon misunderstood in spite of medical progress. Relaxation is a technical for reduce anxiety and is effective and safe. Previous study demonstrated the impact of session relaxation on the autonomous nervous system by the heart rate variability.
Primary objective of this new study is to demonstrate a link between heart rate variability and reduced anxiety during relaxation session.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Saint-etienne、法国、42055
- CHU de Saint-Étienne
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Affiliated or entitled to a social security
- Have signed consent before their participation in the study
- Aged over 18 years
- Patients who will have an orthopedic surgery in full hospitalization
- Patients anxious on visual analogic scale of anxiety (>5)
Exclusion Criteria:
- Different disorder : disability to understand instructions, respiratory insufficiency, obesity, sleep apnea, wearing a pacemaker
- Medical history of schizophrenia or bipolar disorder
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Patients anxious
Patients anxious will be perform relaxation session.
|
During relaxation session, patients anxious will have three electrodes for save heart rate variability and a sensor for save value of the partial pressure of carbon dioxide. Before and after relaxation session, patient evaluates his anxiety by visual analogue scale (VAS) and State-Trait Anxiety Inventory (STAI-Y). |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
high frequency
大体时间：continuously during the relaxation session
|
from the variation of heart rate.
Measured by electrocardiogram.
|
continuously during the relaxation session
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
anxiety
大体时间：after the relaxation session at day 1
|
Measured with the State-Trait Anxiety Inventory (STAI-Y) Interpretation : Very high:> to 65 High: from 56 to 65 Average: from 46 to 55 Low: from 36 to 45 Very low: <or = 35
|
after the relaxation session at day 1
|
|
low frequency
大体时间：continuously during the relaxation session
|
Measured by electrocardiogram.
|
continuously during the relaxation session
|
|
the ratio of high frequencies to low frequencies
大体时间：continuously during the relaxation session
|
Measured by electrocardiogram.
|
continuously during the relaxation session
|
|
PetCO2
大体时间：continuously during the relaxation session
|
measured with a sensor fixed in front of the nostril
|
continuously during the relaxation session
|
合作者和调查者
调查人员
- 首席研究员：Zeina PRADES, MD PhD、CHU Saint-étienne
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 1708097
- ID-RCB (其他标识符：2025-A02583-46)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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