Interest of Cardiac Coherence in the Prevention of Chroni... | NCT04701723

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

NCT04701723

Sponsor

Centre Hospitalier Universitaire de la Réunion

Status

Recruiting

Last Update Posted

Mar 12, 2026Actual

Enrollment

44Estimated

Phase

Not Applicable

Conditions

Post-traumatic Stress Disorder

Interventions

cardiac coherence

Countries

Reunion

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 19, 2021Actual

Primary Completion Date

May 2027Estimated

Completion Date

May 2027Estimated

First Submitted Date

Dec 23, 2020

First Submission Date that Met QC Criteria

Jan 6, 2021

First Posted Date

Jan 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2026

Last Update Posted Date

Mar 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiac Coherence Training	Experimental	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)	Other: cardiac coherence

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiac coherence	Other	standard care associated to cardiac coherence training during 3 months	Cardiac Coherence Training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients without Post-traumatic stress disorder	Measured by the Post Traumatic Stress Disorder CheckList for DSM-5 (PCL-5)	at month 3

Secondary Outcomes

Measure	Description	Time Frame
Complications associated to Post-traumatic stress disorder	number of suicide attempt	at inclusion
Complications associated to Post-traumatic stress disorder	Variation of suicidal risk (Columbia-Suicide Severity Rating Scale or C-SSRS). This scale measure the risk of suicide et will be measured by un external evaluator

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emilie TECHER	Contact	+262 262 90 62 89		emilie.techer@chu-reunion.fr

Overall Officials

Name	Affiliation	Role
Erick GOKALSING	Etablissement Public de Santé Mentale de La Réunion	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Etablissement Public de Santé Mentale de La Réunion	Recruiting	Saint-Paul		97460	Reunion

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided