Mental Health of Professionals Working in Pediatric Intensive Care Units During the COVID-19 Pandemic

January 11, 2022 updated by: D'Or Institute for Research and Education

Mental Health and Emotional Aspects of Professionals Working in Pediatric Intensive Care Units During the COVID-19 Pandemic

Health professionals are extremely exposed to psychosocial risks, as they experience, in general, high levels of stress, anxiety, fatigue and suffering, due to the nature and location of their work. As a result, the health and well being of these professionals can be significantly compromised. In outbreaks of serious infectious diseases and pandemics, these risks become amplified and the health team is at greater risk of falling ill, presenting changes in mental health and psychological trauma, while caring for infected patients and becoming potential contaminants in their family and community.

The objective is to study the mental health of professionals who work in Pediatric Intensive Care Units (PICUs) in Brazil, during and after the COVID-19 pandemic. The primary outcome will be the prevalence of burnout in the team involved with the care of critically ill children. Secondary outcomes such as anxiety, depression, quality of professional life, compassionate fatigue and post-traumatic stress disorder will be measured. Possible associations between demographic, work and coping variables (social support and resilience) with mental and emotional health outcomes will be investigated, in an exploratory character.

It is a multicenter, observational, longitudinal study, with a descriptive and exploratory analytical component. Data collection will be carried out through an electronic survey during and after the COVID-19 pandemic.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Health professionals are extremely exposed to psychosocial risks, as they experience, in general, high levels of stress, anxiety, fatigue and suffering, due to the nature and location of their work. As a result, the health and well being of these professionals can be significantly compromised. In outbreaks of serious infectious diseases and pandemics, these risks become amplified and the health team is at greater risk of falling ill, presenting changes in mental health and psychological trauma, while caring for infected patients and becoming potential contaminants in their family and community.

The objective is to study the mental health of professionals who work in Pediatric Intensive Care Units (PICUs) in Brazil, during and after the COVID-19 pandemic. The primary outcome will be the incidence of burnout in the team involved with the care of critically ill children. Secondary outcomes such as anxiety, depression, quality of professional life, compassionate fatigue and post-traumatic stress disorder will be measured. Possible associations between demographic, work and coping variables (social support and resilience) with mental and emotional health outcomes will be investigated, in an exploratory character.

It is a multicenter, observational, longitudinal study, with a descriptive and exploratory analytical component. Data collection will be carried out through an electronic survey during and after the COVID-19 pandemic.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil, 22281-100
        • D'OR Institute for Research and Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Physicians, registered nurses, nurse technicians, physical therapists and other professionals; on duty, routine staff or fellow/residents working in participants PICU

Description

Inclusion Criteria:

  • Eligible participants that signed informed consent form

Exclusion Criteria:

  • Refused to sign informed consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthcare personnel working in pediatric intensive care units during COVID-19 pandemic
Physicians, registered nurses, nurse technicians, physical therapists and other professionals; on duty, routine staff or fellow/residents working in participants PICU
Other: Web-based survey
Eligible participants received emails or text messages with links to a REDCap-created and managed web-based questionnaire

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of burnout as measured by Maslach Burnout Inventory (MBI)
Time Frame: Baseline
Proportion of participants positive for Burnout as measured by MBI (Maslach et al), a self-report standardized 22-item questionnaire covering 3 domains: emotional exhaustion (EE), depersonalization (DP) and personal accomplishment (PA). Each subscale includes Likert-scaled questions ranging from 0 (never) to 6 (every day). Higher EE and DP scores and lower PA scores, more severe Burnout. Further analysis will be done to evaluate associations between Burnout presence and severity and demographic and laboral characteristics.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of anxiety as measured by Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline
Proportion of participants positive for anxiety as measured by HADS (Zigmond and Snaith), a self-report standardized 14-item questionnaire covering 1 anxiety 7-question subscale and 1 depression 7-question subscale. Each subscale includes Likert-scaled questions ranging from 0 to 3. Presence of anxiety symptoms when 9 or more points on anxiety subscale. Further analysis will be done to evaluate associations between anxiety presence and severity and demographic and laboral characteristics.
Baseline
Prevalence of depression as measured by Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline
Proportion of participants positive for depression as measured by HADS (Zigmond and Snaith), a self-report standardized 14-item questionnaire covering 1 anxiety 7-question subscale and 1 depression 7-question subscale. Each subscale includes Likert-scaled questions ranging from 0 to 3. Presence of depression symptoms when 9 or more points on depression subscale. Further analysis will be done to evaluate associations between depression presence and severity and demographic and laboral characteristics.
Baseline
Prevalence of Post-traumatic Stress Disorder (PTSD) as measured by PTSD Checklist DSM-5 (PCL-5)
Time Frame: Baseline
Proportion of participants positive for PTSD as measured by PCL-5 (Weathers et al), a self-report standardized 20-item questionnaire covering 4 dimensions of symptoms: intrusions, avoidance, negative alterations in cognitions and mood and alterations in arousal and reactivity. Each subscale includes Likert-scaled questions ranging from 0 (not at all) to 4 (extremely). Presence of PTSD symptoms when 33 or more total points or positivity in each dimension. Further analysis will be done to evaluate associations between PTSD presence and severity and demographic and laboral characteristics.
Baseline
Prevalence of Compassion Fatigue as measured by Professional Quality of Life 5 (ProQOL 5) scale
Time Frame: Baseline
Proportion of participants positive for compassion fatigue and satisfaction as measured by ProQOL 5 scale (Stamm), a self-report standardized 30-item questionnaire covering 3 domains: compassion satisfaction (CS), Burnout (BO), secondary traumatic stress (ST). Each subscale includes Likert-scaled questions ranging from 1 (never) to 5 (very often). Scores are scaled between low (22 or less points), moderate (23 to 41) and high (42 or more) levels in each domain. Further analysis will be done to evaluate associations between CS, BO and ST presence and severity and demographic and laboral characteristics.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
D'Or Institute for Research and Education

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fernanda L Setta, D'OR Institute for Research and Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COVID-EMOTION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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