Impact of an Intensive Care Diary on Post-traumatic Stress Disorder After a Resuscitated Sudden Death

NCT02874469 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2025-12-16

No results posted yet for this study

Summary

Sudden death is a public health problem with more than 300,000 cases per year in USA and 40,000 cases per year in France. Moreover, despite all recent therapeutic improvements (therapeutic hypothermia, new techniques of resuscitation…), the prognosis remains drastically poor and less than 50% of the patients admitted alive at hospital will survive to the event at 1 year.

Outside all medications and technical care to improve patient prognosis, a psychological evaluation looks also critical to detect the occurrence of a "post traumatic stress syndrome". In fact, along with the event severity, a variable period of amnesia related to coma may favor the occurrence of such a syndrome and psychological issues, which at the end may lead to impairment of patient quality of life.

Previous studies have evaluated the impact of an intensive care unit diary on psychological distress in patients and relatives in the context of severe traumatisms. Such an evaluation has however never been done in the specific setting of sudden death and the frequency of this syndrome is unknown in this context.

Aim The aim of the present study is to evaluate the impact of an intensive care unit diary on the occurrence of a "post traumatic stress syndrome" after a sudden death.

Secondary objectives

* To evaluate the frequency of the occurrence of a "post traumatic stress syndrome" and other psycho traumatic symptoms after sudden death
* To evaluate the impact of an intensive care unit diary on the severity of this syndrome, psycho traumatic symptoms, and psychopathologic comorbidities
* To evaluate the impact of the diary on psycho traumatic symptoms and their severity in patient's relatives
* To evaluate the satisfaction of the patients and their relatives regarding medical cares in both groups (with and without diary)
* Comparison of nurse diagnostic (psychological distress) and diagnostic made by dedicated personal with a specific formation in psychology
* Qualitative evaluation of the diary
* Evaluation of the paramedical feeling before and after the diary input in practice

Conditions

  • Sudden Death
  • Sudden Cardiac Arrest

Interventions

OTHER

Diary

The diary was specifically created for the purpose of the present study by personal working at ICU at CHRU of Lille (France). All relatives, doctors and paramedics close to the patient during his hospital stay are allowed to write some comments inside the diary when he is comatose. The diary will be implemented during the second period of the study within the first 8 hours after admission. It will be given to the patients themselves at discharge or to their relatives in case of in-hospital death. An anonymous copy will be kept by investigators.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV
  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Gilles LESMESLE, MD, PhD · University Hospital, Lille

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02874469 on ClinicalTrials.gov