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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое cardiac coherence
  standard care associated to cardiac coherence training during 3 months

Первичные конечные точки

• Proportion of patients without Post-traumatic stress disorder [Срок оценки: at month 3]

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Reunion · 1 центр

• Etablissement Public de Santé Mentale de La Réunion — Saint-Paul

Идентификаторы

NCT: NCT04701723 · 2019/CHU/02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗