- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05033223
Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services (COVER PRO LT)
2022년 1월 26일 업데이트: Elisa Letellier, Hospices Civils de Lyon
Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services and SAMU: Multicenter Cohort Study (COVid in EmeRgency PROfessionnals Long Term)
The COVID-19 outbreak has been categorized as a pandemic and declared an international public health emergency by WHO.
In this context, an exceptional mobilization and a complete reorganization of the organization of the healthcare offer was put in place.The investigators will study the psychological consequences among emergency department (ED) / SAMU (Service d'Aide Médicale Urgente) professionals exposed during the COVID-19 pandemic to high psychological stress due to work overload, changes in practices and fears of contamination.They will evaluate at 9 and 12 months after the end of the second lockdown (July December 2020), post-traumatic stress disorder (PTSD), personal and professional stress, anxiety and depression, burn-out and consumption of anxiolytic products.
This is a multi-center study and includes doctors, DE interns and nurses, other paramedics and medical regulatory assistants working in one of the ED or SAMU working during phase 3 of the COVID-19 pandemic.
It should make it possible to know the psychological load of the months following the epidemic among health professionals who worked in emergencies during this period and to understand their risk of occurrence of PTSD.
These elements are also essential to improve the management of health crises and to put in place preventive measures for health professionals, in particular in anticipation of recurrences, second wave or future new episode.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
71
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Pierre-Bénite, 프랑스, 69310
- Service d'Accueil des Urgences
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Adults
- Administrative and technical medical staff of the Hospices Civils de Lyon
- Contractual or holder
- Having participated in the COVER PRO study
- Working in one of the HCL phase 3 departments of the COVID-19 pandemic.
- Affiliated with a social security system
- Having signed an informed consent
Exclusion Criteria:
- Refusal to participate
- Major under legal protection
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Follow-up
|
PCL-5 autoquestionnaire to make the PTSD diagnosis
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Existence of a Post Traumatic Stress Disorder (PTSD) at 12 months using PTSD Scale
기간: 12 months after the end of the second Lockdown (December 2020)
|
: Existence of a PTSD after the end of the second lockdown using the PCL-5 scale (Post Traumatic Stress Disorder Checklist, 20 items, self-questionnaire) validated in French for PTSD screening.
The presence of a "probable PTSD" will be defined by a cut-off score of 31/80 and at least a positive response to one of the four questions asking if the symptoms were causing difficulties in relations with family, friends, work or in daily life
|
12 months after the end of the second Lockdown (December 2020)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Existence of a Post Ttraumatic Stress Disorder (PTSD) 9 months using PTSD Scale
기간: 9months after the end of the second Lockdown (December 2020)
|
Existence of a PTSD after the end of the second lockdown using the PCL-5 scale (Post Traumatic Stress Disorder Checklist, 20 items, self-questionnaire) validated in French for PTSD screening.
The presence of a "probable PTSD" will be defined by a cut-off score of 31/80 and at least a positive response to one of the four questions asking if the symptoms were causing difficulties in relations with family, friends, work or in daily life
|
9months after the end of the second Lockdown (December 2020)
|
|
Anxiety evaluation at 12 months using HAD scale
기간: 12months after the end of the second Lockdown (December 2020)
|
Existence of anxious symptomatology assessed by the HAD scale.
14 items, cut-off score: 8 suspected disorder, 11: proven disorder
|
12months after the end of the second Lockdown (December 2020)
|
|
Anxiety evaluation at 9 months using HAD scale
기간: 9months after the end of the second Lockdown (December 2020)
|
Existence of anxious symptomatology assessed by the HAD scale.
14 items, cut-off score: 8 suspected disorder, 11: proven disorder
|
9months after the end of the second Lockdown (December 2020)
|
|
Depression evaluation at 12 months using HAD scale
기간: 12months after the end of the second Lockdown (December 2020)
|
Existence of depression symptomatology assessed by the HAD scale.
14 items, cut-off score: 8 suspected disorder, 11: proven disorder
|
12months after the end of the second Lockdown (December 2020)
|
|
Depression evaluation at 9 months using HAD scale
기간: 9months after the end of the second Lockdown (December 2020)
|
Existence of depression symptomatology assessed by the HAD scale.
14 items, cut-off score: 8 suspected disorder, 11: proven disorder
|
9months after the end of the second Lockdown (December 2020)
|
|
Presence of a Burn out at 12 months using the Maslach Burnot Inventory (MBI) scale
기간: 12months after the end of the second Lockdown (December 2020)
|
Burnout characterized by the Maslach burnout inventory scale.
All MBI items are scored using a 7 level frequency ratings from "never" to "daily."
The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items).
Each scale measures its own unique dimension of burnout.
|
12months after the end of the second Lockdown (December 2020)
|
|
Presence of a Burn out at 9 months using the MBI scale
기간: 9months after the end of the second Lockdown (December 2020)
|
Burnout characterized by the Maslach burnout inventory scale.
All MBI items are scored using a 7 level frequency ratings from "never" to "daily."
The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items).
Each scale measures its own unique dimension of burnout.
|
9months after the end of the second Lockdown (December 2020)
|
|
Work-related stress measured using Karasek questionnaire at 12 months
기간: 12months after the end of the second Lockdown (December 2020)
|
Work-related stress measured using Karasek questionnaire at 12 months
|
12months after the end of the second Lockdown (December 2020)
|
|
Work-related stress measured using Karasek questionnaire at 9 months
기간: 9months after the end of the second Lockdown (December 2020)
|
Work-related stress measured using Karasek questionnaire at 9 months
|
9months after the end of the second Lockdown (December 2020)
|
|
Consumption of psychoactive substances at 12 months
기간: 12months after the end of the second Lockdown (December 2020)
|
Change in the consumption of psychoactive substances at 12 months
|
12months after the end of the second Lockdown (December 2020)
|
|
Percentage of patients with psychological Support at 12 months
기간: 12months after the end of the second Lockdown (December 2020)
|
Percentage of patients who benefit from a psychological support at 12 months
|
12months after the end of the second Lockdown (December 2020)
|
|
Mean number of days of sick leave at 12 months
기간: 12months after the end of the second Lockdown (December 2020)
|
Mean number of days of sick leave at 12 months
|
12months after the end of the second Lockdown (December 2020)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 10월 12일
기본 완료 (실제)
2022년 1월 16일
연구 완료 (실제)
2022년 1월 16일
연구 등록 날짜
최초 제출
2021년 9월 1일
QC 기준을 충족하는 최초 제출
2021년 9월 1일
처음 게시됨 (실제)
2021년 9월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 1월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 1월 26일
마지막으로 확인됨
2022년 1월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 69HCL21_0311
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .