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Psycho-traumatic Consequences of the COVID-19 Health Crisis Among Professionals in Emergency Services (COVER PRO LT)

2022年1月26日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

71

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • フランス
      • Pierre-Bénite、フランス、69310
        • Service d'Accueil des Urgences

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：ヘルスサービス研究
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
他の：Follow-up
他の：PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemic
PCL-5 autoquestionnaire to make the PTSD diagnosis

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Existence of a Post Traumatic Stress Disorder (PTSD) at 12 months using PTSD Scale
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Existence of a Post Ttraumatic Stress Disorder (PTSD) 9 months using PTSD Scale
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hospices Civils de Lyon

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年10月12日

一次修了 (実際)

2022年1月16日

研究の完了 (実際)

2022年1月16日

試験登録日

最初に提出

2021年9月1日

QC基準を満たした最初の提出物

2021年9月1日

最初の投稿 (実際)

2021年9月2日

学習記録の更新

投稿された最後の更新 (実際)

2022年1月27日

QC基準を満たした最後の更新が送信されました

2022年1月26日

最終確認日

2022年1月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 69HCL21_0311

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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