[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416366":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":48,"studyPopulation":40,"armGroups":49,"interventions":56,"overallOfficials":61,"centralContacts":66,"locations":72,"responsibleParty":88,"collaborators":40,"id":90,"slug":40,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":40,"enrollmentInfo":98,"targetDuration":40,"studyType":101,"phases":102,"briefSummary":103,"conditions":104,"keywords":40,"overallStatus":74,"whyStopped":40,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de la Réunion","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients without Post-traumatic stress disorder","Measured by the Post Traumatic Stress Disorder CheckList for DSM-5 (PCL-5)","at month 3",[14,18,20,23,24,27,28,31,33,35,36],{"measure":15,"description":16,"timeFrame":17},"Complications associated to Post-traumatic stress disorder","number of suicide attempt","at inclusion",{"measure":15,"description":19,"timeFrame":12},"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",{"measure":21,"description":22,"timeFrame":17},"Variation in heart rate variability","measured by time and frequency indices obtained on the tachogram",{"measure":21,"description":22,"timeFrame":12},{"measure":25,"description":26,"timeFrame":17},"Duration of scale completion","timed",{"measure":25,"description":26,"timeFrame":12},{"measure":29,"description":30,"timeFrame":17},"Compliance to Cardiac coherence","percentage of time spent in cardiac coherence",{"measure":29,"description":30,"timeFrame":32},"at month 1",{"measure":29,"description":30,"timeFrame":34},"at month 2",{"measure":29,"description":30,"timeFrame":12},{"measure":37,"description":38,"timeFrame":39},"Proportion of patients who refuse to participate","all screened patient will be recorded","up to month 3",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":45,"observationalModel":40,"timePerspective":40,"maskingInfo":46},"NA","SINGLE_GROUP","Pilot study","PREVENTION",{"masking":47,"maskingDescription":40,"whoMasked":40},"NONE","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.",[50],{"label":51,"type":52,"description":53,"interventionNames":54},"Cardiac Coherence Training","EXPERIMENTAL","The cardiac coherence training will consist in the realization during 3 months by the patient, at home :\n\n* of 6 respiratory cycles by minute (inspiration : 4,5 seconds\u002Fexpiration : 5,5 seconds),\n* during 5 minutes,\n* 3 times a day (morning, late morning and late afternoon)",[55],"Other: cardiac coherence",[57],{"type":6,"name":58,"description":59,"armGroupLabels":60,"otherNames":40},"cardiac coherence","standard care associated to cardiac coherence training during 3 months",[51],[62],{"name":63,"affiliation":64,"role":65},"Erick GOKALSING","Etablissement Public de Santé Mentale de La Réunion","PRINCIPAL_INVESTIGATOR",[67],{"name":68,"role":69,"phone":70,"phoneExt":40,"email":71},"Emilie TECHER","CONTACT","+262 262 90 62 89","emilie.techer@chu-reunion.fr",[73],{"facility":64,"status":74,"city":75,"state":40,"zip":76,"country":77,"countryCode":40,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"RECRUITING","Saint-Paul","97460","Reunion",{"type":79,"coordinates":80},"Point",[81,82],55.27134,-21.00961,{"lat":82,"lon":81},[85,86],{"name":63,"role":69,"phone":40,"phoneExt":40,"email":40},{"name":87,"role":65,"phone":40,"phoneExt":40,"email":40},"Erick GOKALSING, MD",{"type":89,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100416366",false,"NCT04701723","Interest of Cardiac Coherence in the Prevention of Chronic Post-traumatic Stress Disorder: Pilot Study","COHEPS-P","Inclusion Criteria:\n\n* patients seen at medico-psychological emergency cell\n* patients with an acute stress disorder, diagnosed by DSM-5\n* patients who have experienced a potentially traumatic event for the last 3-15 days (vctim or witness)\n* patients able to read and write in French language\n* person affiliated or beneficiary of a social security scheme.\n* person who agrees to participate in the study\n\nExclusion Criteria:\n\n* patients with respiratory pathology not allowing cardiac coherence training\n* patients currently practicing a regular respiratory control technique or within the last 6 months\n* patients taking beta-blocker, betamimetic, anti-arrhythmic, opioid, antidepressant\n* patients with a pacemaker or suffering from severe cardiac illness\n* patients with non-stabilized psychiatric disorder at inclusion\n* patient taking benzodiazepine unable to wean off in the week following the inclusion\n* patients with addiction\n* patients with a cognitive deficit\n* patients under guardianship or curatorship, under judicial supervision","ALL","18 Years",{"count":99,"type":100},44,"ESTIMATED","INTERVENTIONAL",[42],"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.\n\nThis 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.",[105],"Post-traumatic Stress Disorder","2026-03-11",{"date":108,"type":109},"2026-03-12","ACTUAL",{"date":111,"type":109},"2021-07-19",{"date":113,"type":100},"2027-05",{"name":5,"class":6},1]