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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05306171
Other study ID # SDC 4734/18/085
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 10, 2022
Est. completion date December 2023

Study information

Verified date March 2022
Source University of Sao Paulo General Hospital
Contact Carlos V Serrano
Phone 5511 2661-5352
Email cvserranojr@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the effects of online training on self-esteem and occupational stress of healthcare professionals, in order to evaluate the potential of this intervention as a preventive measure to Burnout syndrome. The study will be developed in three phases,the first being the period of one week before the intervention(t0), when instruments will be first applied.The second phase corresponds to intervention period, when the instruments will be reapplied after the second (t1), third (t2) and fourth (t3) training intervention. The third phase corresponds to the follow up (t4-t8), when all instruments used in the second phase will be reapplied in 2 months (t4), 4 months (t5), 6 months (t6), 8 months (t7) and 12 months (t8) after the end of the intervention. The sample will consist of 100 health professionals randomized into two groups (50 in each group): intervention group (I), formed by those who will participate in the online training and control group (C), formed by those who will receive the intervention after research is finished. The hypotheses are: the online training will have greater effect on the increase of self-esteem, and will be identified in health professionals: low levels of global self-esteem, high levels of occupational stress and average levels of burnout.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2023
Est. primary completion date July 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Health professionals who work at University of Sao Paulo General Hospital - Agree and sign the Inform Consent Form. Exclusion Criteria: - Those who, one week before training, presents anxiety and depressive symptoms (GAD = 14 e/ou PHQ = 14) - in psychotherapy during data collection; - diagnosed with Burnout syndrome.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Online training for healthcare professionals
The online training (4 modules) will use the technique of hybrid learning, combining meetings that will require the presence of participants and mediator at the same time and platform (live) with recorded meetings (interviews with experts) that will be watched by the participants at any time (from a distance). Module 1: Self Care; Module 2: Stress and anxiety management; Module 3: Relationships; Module 4: Communication.

Locations

Country Name City State
Brazil Heart Institute of the Hospital das Clínicas, University of São Paulo Medical School São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self esteem Assessed by the instrument Rosenberg Self Esteem Scale(RSES) Through study completion, an average of 1 year and 4 months
Primary Occupational Stress Assessed by the instrument Stress Questionnaire for Health Professionals (SQHP) Through study completion, an average of 1 year and 4 months
Primary Burnout Assessed by the instrument Copenhagen Burnout Inventory(CBI) Through study completion, an average of 1 year and 4 months
Secondary Anxiety Assessed by the instrument Generalized Anxiety Disorder-7 (GAD-7) Through study completion, an average of 1 year and 4 months
Secondary Depression Assessed by the instrument Patient Health Questionnaire - 9 (PHQ-9) Through study completion, an average of 1 year and 4 months
Secondary Covid-19 impact Assessed by the instrument Impact of Event Scale - Revised (IES -Rs) Through study completion, an average of 1 year and 4 months
Secondary Improvement in general health after entering the study. Assessed by the instrument Patient Global Improvement Change Scale (PGIC) Through study completion, an average of 1 year and 2 months
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