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

NCT ID: NCT04701723

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-19
• Study Completion Date: 2024-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

Post-traumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

cardiac coherence

Intervention Type: OTHER

standard care associated to cardiac coherence training during 3 months

Interventions

cardiac coherence

standard care associated to cardiac coherence training during 3 months

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erick GOKALSING

Role: PRINCIPAL_INVESTIGATOR

Etablissement Public de Santé Mentale de La Réunion

Locations

Etablissement Public de Santé Mentale de La Réunion

Saint-Paul, , Reunion

Site Status: RECRUITING

Countries

Reunion

Central Contacts

Emilie TECHER

Role: CONTACT

emilie.techer@chu-reunion.fr

+262 262 90 62 89

Facility Contacts

Erick GOKALSING

Role: primary

Other Identifiers

2019/CHU/02

Identifier Type: -

Identifier Source: org_study_id