Distress, Emotional Clinical Trial
— BE-STRONGOfficial title:
Investigation on Psycological Well-being in Healthcare Workers of San Raffaele Institution During COVID-19 Emergency Context
NCT number | NCT04890600 |
Other study ID # | RP 20/14 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2020 |
Est. completion date | April 1, 2021 |
Verified date | May 2021 |
Source | IRCCS San Raffaele Roma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Well-being of healthcare workers is assessed by specific questionaries validated for resilience, depression, anxiety, coping strategies and fear for COVID-19. After signing informed consent and privacy informed consent subject are asked to complete questionaries presented as google modules. No personal data are required.
Status | Completed |
Enrollment | 350 |
Est. completion date | April 1, 2021 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Healthworkers of San Raffaele Institution - age>18 Exclusion Criteria: - all those who do not agree |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS San Raffaele Roma | Rome |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele Roma |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Levels of anxiety and depression | Hospital Anxiety and Depression Scale (HADS) Consists of 14 questions, each of which is rated from 0 to 4 according to the severity of the experienced symptoms. | 6 months | |
Primary | Coping strategies | Brief-COPE Consists of 28 items divided into 14 scales, relating to 14 identified coping strategies. Each item is rated on a 4 points Likert scale. | 6 months | |
Primary | Levels of resilience | 14-Item Resilience Scale Consists of 14 items, each rated on a 7 levels Likert scale and evaluates the levels of resilience. | 6 months | |
Primary | Levels of fear of COVID-19 | FEAR OF COVID-19 SCALE Consists of 7 items, each rated on a Likert scale from 1 to 5, with the aim of assessing the levels of fear related to COVID-19 | 6 months |
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