Psychological Sequelae After Sudden Cardiac Death in the Patient and His Relatives

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder; Resuscitated Sudden Cardiac Death
• Interventions: Behavioral: SASRQ questionnaire; Behavioral: PCL-5 with LEC-5 questionnaire

• Registration Number: NCT04921514
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

This study will evaluate and describe the occurrence of Acute traumatic stress and persistence of Post Traumatic Stress Disorder (PTSD) after resuscitated sudden cardiac death (SCD) in patient and relatives present during the event. The population will be composed of 40 patients: 20 with resuscitated SCD and 20 relatives. Two interviews will be performed by a psychologist within one week after resuscitated SCD and at month 3. Questionnaire Stanford Acute Stress Reaction Questionnaire (SASRQ), Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (LEC-5) and Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) will be filled during these interviews.

Detailed Description

In spite of therapeutic advances, sudden cardiac death (SCD) remains a frequent (60000/year in France) and often fatal disease (5% survival). Because it is by definition unexpected, the psychological impact on resuscitated patients and on relatives may be important. However little studies have evaluated it. Patients who later develop PTSD, generally have acute stress disorder. In patients with resuscitated sudden cardiac death, acute psychological distress is frequent and PTSD was identified in 40% of patients. Concerning relatives, Haywood (2018) call them the "forgotten patients" to emphasize the absence of recognition of his psychological trauma. PTSD was more frequent in people who were witness of the SCD vs those who were not there. Hofland et al (2018) showed that people present during resuscitation maneuvers had more acute stress than others.

This study will evaluate acute stress disorder with SASRQ scale in patients with resuscitated SCD and their relative just after the event. At 3 months, presence of PTSD will be evaluated with PCL-5 and LEC-5 in patients and their relatives.

Study Timeline

• Study Start: 2021-05-18
• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-04
• Study First Posted: 2021-06-10
• Primary Completion: 2022-09-26
• Study Completion: 2022-09-26
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Patients with resuscitated sudden cardiac death and/or their relative
• Patients who are fluent in French
• Patients who have given their 'no objection to participation to the research'
• Patients of both gender over 18 years
• Women with childbearing potential and effective contraception

Exclusion Criteria

• People who are not able to give their 'no objection to participate to the research'
• People with major cognitive disorders post sudden cardiac death
• People with known psychiatric disorder
• Women who are known to be pregnant or lactating
• Person deprived of liberty by judicial or administrative decision
• People under legal protection (under the protection of a conservator)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient and relatives	SASRQ questionnaire	-
Patient and relatives	PCL-5 with LEC-5 questionnaire	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients and relatives with PTSD at months 3 post resuscitated SCD	Month 3	The percentage of patients and relatives is determined using the PCL-5 and LEC-5 questionnaire

Secondary Outcome Measures

Name	Time	Method
Proportion of patients and/or relatives with acute stress disorder	Day 0	The percentage of patients and relatives is determined using the SASRQ questionnaire
Proportion of patients and/or relatives with trauma vulnerability	Month3	The percentage of patients and/or relatives is determined using the LEC-5 included in the PCL-5 questionnaire

Trial Locations

Locations (1)

Bordeaux University Hospital; 🇫🇷 Pessac, France