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临床试验/NCT03324048
NCT03324048已完成不适用

A Single Mindfulness Meditation Session in Preoperative Anxiety : Effects on the Autonomous Nervous System

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2017年11月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
high frequency

研究概览

简要总结

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.

详细描述

It is monocentric, prospective and interventional study. This study will be proposed at the patients who will have an orthopedic surgery in full hospitalization. These patients are anxious because of surgery too. The day before surgery anesthetist save heart rate variability and value of the partial pressure of carbon dioxide during relaxation session.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • Different disorder : disability to understand instructions, respiratory insufficiency, obesity, sleep apnea, wearing a pacemaker
  • Medical history of schizophrenia or bipolar disorder

研究组 & 干预措施

Patients anxious

Other

Patients anxious will be perform relaxation session.

干预措施: relaxation session (Other)

结局指标

主要结局

high frequency

时间窗: continuously during the relaxation session

from the variation of heart rate. Measured by electrocardiogram.

次要结局

  • anxiety(after the relaxation session at day 1)
  • low frequency(continuously during the relaxation session)
  • the ratio of high frequencies to low frequencies(continuously during the relaxation session)
  • PetCO2(continuously during the relaxation session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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