BurnoutNCT05306171
Online Training for Healthcare Professionals: a Possible Strategy for Prevention of Burnout
A study testing Online training for healthcare professionals in people with Burnout, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout
- What is being tested?
- Online training for healthcare professionals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Mar 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Health professionals who work at University of Sao Paulo General Hospital
- Agree and sign the Inform Consent Form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute of the Hospital das Clínicas, University of São Paulo Medical School
São Paulo, 05403-900
2661-5352
About this study
Official title: Effects of Online Training on Self-esteem and Occupational Stress of Healthcare Professionals: a Possible Strategy for Prevention of Burnout Syndrome.
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.
- Conditions
- Burnout
- Being tested
- Online training for healthcare professionals
- Keywords
- Burnout Syndrome, Self Esteem, Occupational Stress, Online Training, Health Professionals
- Medical subject headings
- Burnout, Psychological, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online training for healthcare professionalsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (I) | Experimental | Online training for healthcare professionals which will follow a protocol made especially for this research. The online training is composed by 4 modules and each module has 3 meetings. Each meeting has 35 minutes long. Receives: Behavioral: Online training for healthcare professionals |
| Control group (C) | No intervention | No intervention. The control group will receive the intervention after study is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self esteem
Assessed by the instrument Rosenberg Self Esteem Scale(RSES)
Measured: Through study completion, an average of 1 year and 4 months
Occupational Stress
Assessed by the instrument Stress Questionnaire for Health Professionals (SQHP)
Measured: Through study completion, an average of 1 year and 4 months
Burnout
Assessed by the instrument Copenhagen Burnout Inventory(CBI)
Measured: Through study completion, an average of 1 year and 4 months
Secondary outcomes (4)
Anxiety
Assessed by the instrument Generalized Anxiety Disorder-7 (GAD-7)
Measured: Through study completion, an average of 1 year and 4 months
Depression
Assessed by the instrument Patient Health Questionnaire - 9 (PHQ-9)
Measured: Through study completion, an average of 1 year and 4 months
Covid-19 impact
Assessed by the instrument Impact of Event Scale - Revised (IES -Rs)
Measured: Through study completion, an average of 1 year and 4 months
Improvement in general health after entering the study.
Assessed by the instrument Patient Global Improvement Change Scale (PGIC)
Measured: Through study completion, an average of 1 year and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start10 Mar 2022
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnoutStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Vicente Serrano Jr, University of Sao Paulo General Hospital
- Investigators
- Patrícia Perniciotti Almeida Costa, Phd student, Principal investigator, University of Sao Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306171
- Sponsor's protocol ID
- SDC 4734/18/085
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Online Training on Self-esteem and Occupational Stress of Healthcare Professionals: a Possible Strategy for Prevention of Burnout Syndrome.
- ClinicalTrials.gov ID
- NCT05306171
- Acronym / sponsor ID
- SDC 4734/18/085
- Conditions
- Burnout
- Keywords
- Burnout Syndrome, Self Esteem, Occupational Stress, Online Training, Health Professionals
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (I) | Experimental | Behavioral: Online training for healthcare professionalsOnline training for healthcare professionals which will follow a protocol made especially for this research. The online training is composed by 4 modules and each module has 3 meetings. Each meeting has 35 minutes long. |
| Control group (C) | No intervention | –No intervention. The control group will receive the intervention after study is completed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Health professionals who work at University of Sao Paulo General Hospital
- Agree and sign the Inform Consent Form.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online training for healthcare professionalsThe 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. | Behavioural | Intervention group (I) |
Primary outcome
Self esteem
Time frame: Through study completion, an average of 1 year and 4 months
Assessed by the instrument Rosenberg Self Esteem Scale(RSES)
Occupational Stress
Time frame: Through study completion, an average of 1 year and 4 months
Assessed by the instrument Stress Questionnaire for Health Professionals (SQHP)
Burnout
Time frame: Through study completion, an average of 1 year and 4 months
Assessed by the instrument Copenhagen Burnout Inventory(CBI)
4 secondary outcomes
Anxiety
Time frame: Through study completion, an average of 1 year and 4 months
Depression
Time frame: Through study completion, an average of 1 year and 4 months
Covid-19 impact
Time frame: Through study completion, an average of 1 year and 4 months
Improvement in general health after entering the study.
Time frame: Through study completion, an average of 1 year and 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrícia Perniciotti Almeida Costa, Phd student principal investigator
University of Sao Paulo Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online training for healthcare professionals in people with Burnout, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos V Serrano (5511 2661-5352, cvserranojr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self esteem (time frame: Through study completion, an average of 1 year and 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.