Interest of Cardiac Coherence in the Prevention of Chronic Post-traumatic Stress Disorder: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Proportion of patients without Post-traumatic stress disorder
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 否
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 (Other)
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)