Covid19 Clinical Trial
— BONSAIOfficial title:
Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling (Bonsai Study) wIth COVID-19: a Randomised Controlled Trial
Verified date | September 2021 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this work is to monitor the level of stress and overload of a group of front-line health workers (physicians, nurses and physiotherapists) who will participate in the care of patients with COVID-19 at Hospital das Clínicas in Ribeirão Preto and its Emergency Unit (HCRP), for four weeks, and evaluate the cannabidiol - CBD's effectiveness in reducing stress for those who wish to use it.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 16, 2020 |
Est. primary completion date | November 16, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 24 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. age between 24 and 60 years old 2. Research participants of both sexes. 3. HCFMRP physicians, nurses and physiotherapists involved in the care of patients who have undergone screening and present at least one symptom, which may be related to infection by COVID-19. 4. Good health conditions and without conditions that characterize them as belonging to the risk groups associated with COVID infection19. 5. Research participants with the potential to become pregnant may be included in the study as long as they are sexually abstinent or using a contraceptive method considered effective. 6. Signature of the Free and Informed Consent Term approved (ICF) by the Research Ethics Committee (CEP) and CONEP. Exclusion Criteria: 1. Using any medication with potential interaction with CBD or with a history of undesirable reactions prior to the use of this cannabinoid. 2. Physicians, nurses and physiotherapists with occasional contact with patients with COVID-19 and who are not responsible for the continuous monitoring of these patients. 3. Although in the HC-FMRP-USP care allocation policy, professionals who are eventually more susceptible to complications from the new coronavirus will be relocated to not attend patients with COVID19, it will be checked again to exclude patients with chronic diseases: diabetes, hypertension, lung disease like asthma or COPD; hematological diseases, chronic kidney disease and immunodepression. 4. Professionals over 60 years old 5. Female research participants who become pregnant or male participants who have their pregnant partner during the research project |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP | Ribeirão Preto | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | aMBI-HSS: Abbreviated Maslach Burnout Inventory - Human Services Survey | To assess the emotional exhaustion dimension of the burnout syndrome, based on nine items, scored from 0 ("never") to 6 ("every day") | Through study completion, over time during the study period (day 0-28) | |
Secondary | Brief measure for assessing generalized anxiety disorder: The GAD-7 | brief measure for assessing generalized anxiety disorder | Through study completion, over time during the study period (day 0-28) | |
Secondary | PHQ-9: Patient´s Health Questionnaire-9 | Evaluate depressive symptoms o | Through study completion, over time during the study period (day 0-28) | |
Secondary | Change in proinflammatory cytokine concentration | Laboratory parameters, including the change in proinflammatory cytokine concentrations | Through study completion, over time during the study period (day 0-28) | |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Occurrence of side effects | Through study completion, over time during the study period (day 0-28) | |
Secondary | Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) | It is a self-report measure widely used to assess PTSD symptoms, according to the DSM-5 criteria. The reduced version of this instrument will be used (8 items) | Through study completion, over time during the study period (day 0-28) |
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