Hospital Interns Psychological State During the COVID-19 (RESICOV)
22 października 2021 zaktualizowane przez: University Hospital, Montpellier
Hospital Interns Psychological State During the COVID-19 Pandemic
The mental health of the French population in response to covid-19 pandemic is of concern.
Health professionals are prone to more mental disorders due to their direct exposure to the pandemic consequences. Indeed, compared to general population, health care workers face enormous in the current health situation, especially those who may be in contact with suspected or confirmed cases (risk of infection, inadequate protection, loss of control, lack of experience in managing the diseases, overwork, stigma, lack of support). Thus, it seems interesting to describe the psychological state of hospital interns during this pandemic.
Przegląd badań
Status
Zakończony
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
102
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
-
Montpellier, Francja, 34295
- University Hospital
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Occitanie-Est hospital interns
Opis
Inclusion criteria:
- Being a DES intern (Occitanie-Est)
- Being on internship as of November 1, 2020
Exclusion criteria:
- Refusal to participate
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Depressive Symptomatology (PHQ-9)
Ramy czasowe: at 5 months (6 months of internship)
|
evaluation of the participant depressive symptomatology based on the PHQ-9 scale.
The PHQ-9 total score ranges from 0 to 27.
A score between 0 and 4 indicates absence of depression; a score between 5 and 9 indicates mild depression; a score between 10 and 14 indicates moderate depression; score between 15 and 19 indicates moderately severe depression and score between 20 and 27 indicates sever depression.
|
at 5 months (6 months of internship)
|
|
Depressive Symptomatology (PHQ-9)
Ramy czasowe: at inclusion (1 month of internship)
|
evaluation of the participant depressive symptomatology based on the PHQ-9 scale.
The PHQ-9 total score ranges from 0 to 27.
A score between 0 and 4 indicates absence of depression; a score between 5 and 9 indicates mild depression; a score between 10 and 14 indicates moderate depression; score between 15 and 19 indicates moderately severe depression and score between 20 and 27 indicates sever depression.
|
at inclusion (1 month of internship)
|
|
Depressive Symptomatology (PHQ-9)
Ramy czasowe: at 2 months (3 months of internship)
|
evaluation of the participant depressive symptomatology based on the PHQ-9 scale.
The PHQ-9 total score ranges from 0 to 27.
A score between 0 and 4 indicates absence of depression; a score between 5 and 9 indicates mild depression; a score between 10 and 14 indicates moderate depression; score between 15 and 19 indicates moderately severe depression and score between 20 and 27 indicates sever depression.
|
at 2 months (3 months of internship)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Sleep evaluation with the Insomnia Severity Index (ISI)
Ramy czasowe: at inclusion (1 month of internship)
|
sleep quality evaluation based on the ISI score.
The ISI total score ranges from 0 to 28.
A score between 0 and 7 indicates an absence of insomnia; a score between 8 and 14 indicates sub-threshold insomnia; a score between 15 and 21 indicates moderate insomnia and a score between 22 and 28 indicates severe insomnia.
|
at inclusion (1 month of internship)
|
|
Sleep evaluation with the Insomnia Severity Index (ISI)
Ramy czasowe: at 2 months (3 months of internship)
|
sleep quality evaluation based on the ISI score.
The ISI total score ranges from 0 to 28.
A score between 0 and 7 indicates an absence of insomnia; a score between 8 and 14 indicates sub-threshold insomnia; a score between 15 and 21 indicates moderate insomnia and a score between 22 and 28 indicates severe insomnia.
|
at 2 months (3 months of internship)
|
|
Sleep evaluation with the Insomnia Severity Index (ISI)
Ramy czasowe: at 5 months (6 months of internship)
|
sleep quality evaluation based on the ISI score.
The ISI total score ranges from 0 to 28.
A score between 0 and 7 indicates an absence of insomnia; a score between 8 and 14 indicates sub-threshold insomnia; a score between 15 and 21 indicates moderate insomnia and a score between 22 and 28 indicates severe insomnia.
|
at 5 months (6 months of internship)
|
|
Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)
Ramy czasowe: at inclusion (1 month of internship)
|
anxiety evaluation based on the GAD-7 score.
The GAD-7 total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
|
at inclusion (1 month of internship)
|
|
Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)
Ramy czasowe: at 2 months (3 months of internship)
|
anxiety evaluation based on the GAD-7 score.
The GAD-7 total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
|
at 2 months (3 months of internship)
|
|
Anxiety with the Generalised Anxiety Disorder Assessment (GAD-7)
Ramy czasowe: at 5 months (6 months of internship)
|
anxiety evaluation based on the GAD-7 score.
The GAD-7 total score ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
|
at 5 months (6 months of internship)
|
|
Psychological pain assessed with visual analogue scale (VAS)
Ramy czasowe: at inclusion (1 month of internship)
|
assessment of the psychological pain.
The VAS ranges from 0 (none) to 10 (maximum pain).
|
at inclusion (1 month of internship)
|
|
Psychological pain assessed with visual analogue scale (VAS)
Ramy czasowe: at 2 months (3 months of internship)
|
assessment of the psychological pain.
The VAS ranges from 0 (none) to 10 (maximum pain).
|
at 2 months (3 months of internship)
|
|
Psychological pain assessed with visual analogue scale (VAS)
Ramy czasowe: at 5 months (6 months of internship)
|
assessment of the psychological pain.
The VAS ranges from 0 (none) to 10 (maximum pain).
|
at 5 months (6 months of internship)
|
|
Physical pain assessed with visual analogue scale (VAS)
Ramy czasowe: at inclusion (1 month of internship)
|
assessment of the physical pain.
The VAS ranges from 0 (none) to 10 (maximum pain).
|
at inclusion (1 month of internship)
|
|
Physical pain assessed with visual analogue scale (VAS)
Ramy czasowe: at 2 months (3 months of internship)
|
assessment of the physical pain.
The VAS ranges from 0 (none) to 10 (maximum pain).
|
at 2 months (3 months of internship)
|
|
Physical pain assessed with visual analogue scale (VAS)
Ramy czasowe: at 5 months (6 months of internship)
|
assessment of the physical pain.
The VAS ranges from 0 (none) to 10 (maximum pain).
|
at 5 months (6 months of internship)
|
|
Suicidal ideation assessed with visual analogue scale (VAS)
Ramy czasowe: at inclusion (1 month of internship)
|
assessment of the suicidal ideation.
The VAS ranges from 0 (none) to 10 (maximum ideation).
|
at inclusion (1 month of internship)
|
|
Suicidal ideation assessed with visual analogue scale (VAS)
Ramy czasowe: at 2 months (3 months of internship)
|
assessment of the suicidal ideation.
The VAS ranges from 0 (none) to 10 (maximum ideation).
|
at 2 months (3 months of internship)
|
|
Suicidal ideation assessed with visual analogue scale (VAS)
Ramy czasowe: at 5 months (6 months of internship)
|
assessment of the suicidal ideation.
The VAS ranges from 0 (none) to 10 (maximum ideation).
|
at 5 months (6 months of internship)
|
|
Anger assessed with the State Anger Expression Inventory (STAXI - state)
Ramy czasowe: at 2 months (3 months of internship)
|
anger assessment with the STAXI state scale.
The total score ranges from 0 to 50.
The higher the score the higher the anger expression.
|
at 2 months (3 months of internship)
|
|
Anger assessed with the State Anger Expression Inventory (STAXI - state)
Ramy czasowe: at 5 months (6 months of internship)
|
anger assessment with the STAXI state scale.
The total score ranges from 0 to 50.
The higher the score the higher the anger expression.
|
at 5 months (6 months of internship)
|
|
Anger assessed with the State Anger Expression Inventory (STAXI - state)
Ramy czasowe: at inclusion (1 month of internship)
|
anger assessment with the STAXI state scale.
The total score ranges from 0 to 50.
The higher the score the higher the anger expression.
|
at inclusion (1 month of internship)
|
|
Stressful Event Impact (Horowitz scale)
Ramy czasowe: at inclusion (1 month of internship)
|
assessement of stressful event impact with the Horowitz scale.
The total score ranges from 0 to 45.
The higher the score the higher the trauma
|
at inclusion (1 month of internship)
|
|
Stressful Event Impact (Horowitz scale)
Ramy czasowe: at 2 months (3 months of internship)
|
assessement of stressful event impact with the Horowitz scale.
The total score ranges from 0 to 45.
The higher the score the higher the trauma
|
at 2 months (3 months of internship)
|
|
Stressful Event Impact (Horowitz scale)
Ramy czasowe: at 5 months (6 months of internship)
|
assessement of stressful event impact with the Horowitz scale.
The total score ranges from 0 to 45.
The higher the score the higher the trauma
|
at 5 months (6 months of internship)
|
|
Psychotropic drugs use
Ramy czasowe: at inclusion (1 month of internship)
|
assessement of the psychotropic drugs use increase
|
at inclusion (1 month of internship)
|
|
Psychotropic drugs use
Ramy czasowe: at 5 months (6 months of internship)
|
assessement of the psychotropic drugs use increase
|
at 5 months (6 months of internship)
|
|
Psychotropic drugs use
Ramy czasowe: at 2 months (3 months of internship)
|
assessement of the psychotropic drugs use increase
|
at 2 months (3 months of internship)
|
|
Tobacco consumption
Ramy czasowe: at 2 months (3 months of internship)
|
assessement of the tobacco consumption increase
|
at 2 months (3 months of internship)
|
|
Tobacco consumption
Ramy czasowe: at inclusion (1 month of internship)
|
assessement of the tobacco consumption increase
|
at inclusion (1 month of internship)
|
|
Tobacco consumption
Ramy czasowe: at 5 months (6 months of internship)
|
assessement of the tobacco consumption increase
|
at 5 months (6 months of internship)
|
|
Alcohol consumption
Ramy czasowe: at 2 months (3 months of internship)
|
assessement of the alcohol consumption increase
|
at 2 months (3 months of internship)
|
|
Alcohol consumption
Ramy czasowe: at inclusion (1 month of internship)
|
assessement of the alcohol consumption increase
|
at inclusion (1 month of internship)
|
|
Alcohol consumption
Ramy czasowe: at 5 months (6 months of internship)
|
assessement of the alcohol consumption increase
|
at 5 months (6 months of internship)
|
|
Illicit substances use
Ramy czasowe: at inclusion (1 month of internship)
|
assessement of the illicit substances use increase
|
at inclusion (1 month of internship)
|
|
Illicit substances use
Ramy czasowe: at 2 months (3 months of internship)
|
assessement of the illicit substances use increase
|
at 2 months (3 months of internship)
|
|
Illicit substances use
Ramy czasowe: at 5 months (6 months of internship)
|
assessement of the illicit substances use increase
|
at 5 months (6 months of internship)
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Dyrektor Studium: Emilie Olie, MD PhD, University Hospital, Montpellier
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 grudnia 2020
Zakończenie podstawowe (Rzeczywisty)
30 maja 2021
Ukończenie studiów (Rzeczywisty)
30 lipca 2021
Daty rejestracji na studia
Pierwszy przesłany
14 grudnia 2020
Pierwszy przesłany, który spełnia kryteria kontroli jakości
14 grudnia 2020
Pierwszy wysłany (Rzeczywisty)
16 grudnia 2020
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
25 października 2021
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
22 października 2021
Ostatnia weryfikacja
1 października 2021
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia psychiczne
- Zakażenia koronawirusem
- Zakażenia Coronaviridae
- Infekcje Nidovirales
- Zakażenia wirusem RNA
- Choroby wirusowe
- Infekcje
- Infekcje dróg oddechowych
- Choroby Układu Oddechowego
- Zapalenie płuc, wirusowe
- Zapalenie płuc
- Choroby płuc
- Zaburzenia związane z traumą i stresem
- Zaburzenia stresowe, traumatyczne
- COVID-19
- Zaburzenia stresowe, pourazowe
Inne numery identyfikacyjne badania
- RECHMPL20_0665
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Opis planu IPD
NC
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .