NCT05306171

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

March 10, 2022

Last Update Submit

March 22, 2022

Conditions

Keywords

Burnout SyndromeSelf EsteemOccupational StressOnline TrainingHealth Professionals

Outcome Measures

Primary Outcomes (3)

  • Self esteem

    Assessed by the instrument Rosenberg Self Esteem Scale(RSES)

    Through study completion, an average of 1 year and 4 months

  • Occupational Stress

    Assessed by the instrument Stress Questionnaire for Health Professionals (SQHP)

    Through study completion, an average of 1 year and 4 months

  • Burnout

    Assessed by the instrument Copenhagen Burnout Inventory(CBI)

    Through study completion, an average of 1 year and 4 months

Secondary Outcomes (4)

  • Anxiety

    Through study completion, an average of 1 year and 4 months

  • Depression

    Through study completion, an average of 1 year and 4 months

  • Covid-19 impact

    Through study completion, an average of 1 year and 4 months

  • Improvement in general health after entering the study.

    Through study completion, an average of 1 year and 2 months

Study Arms (2)

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.

Behavioral: Online training for healthcare professionals

Control group (C)

NO INTERVENTION

No intervention. The control group will receive the intervention after study is completed.

Interventions

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.

Intervention group (I)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Health professionals who work at University of Sao Paulo General Hospital
  • Agree and sign the Inform Consent Form.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute of the Hospital das Clínicas, University of São Paulo Medical School

São Paulo, 05403-900, Brazil

RECRUITING

MeSH Terms

Conditions

Burnout, PsychologicalOccupational Stress

Interventions

Health Personnel

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorOccupational Diseases

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

  • Patrícia Perniciotti Almeida Costa, Phd student

    University of Sao Paulo Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 31, 2022

Study Start

March 10, 2022

Primary Completion

July 1, 2023

Study Completion

December 1, 2023

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations