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

U

University Hospital of Bordeaux

Status

Completed

Conditions

Post Traumatic Stress Disorder
Resuscitated Sudden Cardiac Death

Treatments

Behavioral: PCL-5 with LEC-5 questionnaire
Behavioral: SASRQ questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT04921514
CHUBX 2020/44

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 1 patient group

Patient and relatives
Experimental group
Treatment:
Behavioral: SASRQ questionnaire
Behavioral: PCL-5 with LEC-5 questionnaire

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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