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临床试验/NCT04701723
NCT04701723
招募中
不适用

Interest of Cardiac Coherence in the Prevention of Chronic Post-traumatic Stress Disorder: Pilot Study

Centre Hospitalier Universitaire de la Réunion1 个研究点 分布在 1 个国家目标入组 44 人2021年7月19日

概览

阶段
不适用
干预措施
cardiac coherence
疾病 / 适应症
Post-traumatic Stress Disorder
发起方
Centre Hospitalier Universitaire de la Réunion
入组人数
44
试验地点
1
主要终点
Proportion of patients without Post-traumatic stress disorder
状态
招募中
最后更新
上个月

概览

简要总结

ThThe aim of this study is to determinate the potential benefits of a respiratory training program (cardiac coherence, CC) in patients suffering from acute stress disorder, after a potentially traumatic event. Using this method is supposed to prevent the onset of chronic post traumatic stress disorder after 3 months.

This pilot study will help to determinate the need of developing this kind of complementary and alternative program, and will also provide knowledge about the feasibiility and acceptability of this program for the patients.

详细描述

Each patient will be teached how to use cardiac coherence with a trained practitioner at the inclusion visit. A respiratory guide on smartphone will be given to the patient aswell as a diary in order to keep tracks of the patient's compliance to this program.

注册库
clinicaltrials.gov
开始日期
2021年7月19日
结束日期
2027年5月1日
最后更新
上个月
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
责任方
Sponsor

入排标准

入选标准

  • patients seen at medico-psychological emergency cell
  • patients with an acute stress disorder, diagnosed by DSM-5
  • patients who have experienced a potentially traumatic event for the last 3-15 days (vctim or witness)
  • patients able to read and write in French language
  • person affiliated or beneficiary of a social security scheme.
  • person who agrees to participate in the study

排除标准

  • patients with respiratory pathology not allowing cardiac coherence training
  • patients currently practicing a regular respiratory control technique or within the last 6 months
  • patients taking beta-blocker, betamimetic, anti-arrhythmic, opioid, antidepressant
  • patients with a pacemaker or suffering from severe cardiac illness
  • patients with non-stabilized psychiatric disorder at inclusion
  • patient taking benzodiazepine unable to wean off in the week following the inclusion
  • patients with addiction
  • patients with a cognitive deficit
  • patients under guardianship or curatorship, under judicial supervision

研究组 & 干预措施

Cardiac Coherence Training

The cardiac coherence training will consist in the realization during 3 months by the patient, at home : * of 6 respiratory cycles by minute (inspiration : 4,5 seconds/expiration : 5,5 seconds), * during 5 minutes, * 3 times a day (morning, late morning and late afternoon)

干预措施: cardiac coherence

结局指标

主要结局

Proportion of patients without Post-traumatic stress disorder

时间窗: at month 3

Measured by the Post Traumatic Stress Disorder CheckList for DSM-5 (PCL-5)

次要结局

  • Proportion of patients who refuse to participate(up to month 3)
  • Complications associated to Post-traumatic stress disorder(at month 3)
  • Variation in heart rate variability(at month 3)
  • Duration of scale completion(at month 3)
  • Compliance to Cardiac coherence(at month 3)
  • Complications associated to Post-traumatic stress disorder(at inclusion)
  • Variation in heart rate variability(at inclusion)
  • Duration of scale completion(at inclusion)
  • Compliance to Cardiac coherence(at inclusion)
  • Compliance to Cardiac coherence(at month 1)
  • Compliance to Cardiac coherence(at month 2)

研究点 (1)

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