Covid19NCT04846907
Mental Health of Professionals Working in Pediatric Intensive Care Units During the COVID-19 Pandemic
An observational study of Covid19 and Burnout, Professional, run by D'Or Institute for Research and Education at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Burnout, Professional, Stress Disorders, Post-Traumatic
- What is being tested?
- Web-based survey
- How many people
- 1,148 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2020to Dec 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Physicians, registered nurses, nurse technicians, physical therapists and other professionals; on duty, routine staff or fellow/residents working in participants PICU
Who may be able to join
- Eligible participants that signed informed consent form
Who cannot join
- Refused to sign informed consent form
Trial locations and contacts
1 site in 1 country.
Brazil1 site
D'Or Institute for Research and Education
Rio de Janeiro, 22281-100
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, Burnout, Professional, Stress Disorders, Post-Traumatic, Anxiety, Depression, Compassion Fatigue
- Being tested
- Web-based survey
- Keywords
- Covid19, Burnout, Post-Traumatic Stress Disorder, Anxiety, Depression, Compassion Fatigue
- Medical subject headings
- COVID-19, Burnout, Professional, Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression, Compassion Fatigue, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based surveyOther
Eligible participants received emails or text messages with links to a REDCap-created and managed web-based questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Web-based survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of burnout as measured by Maslach Burnout Inventory (MBI)
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.
Measured: Baseline
Secondary outcomes (4)
Prevalence of anxiety as measured by Hospital Anxiety and Depression Scale (HADS)
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.
Measured: Baseline
Prevalence of depression as measured by Hospital Anxiety and Depression Scale (HADS)
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.
Measured: Baseline
Prevalence of Post-traumatic Stress Disorder (PTSD) as measured by PTSD Checklist DSM-5 (PCL-5)
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.
Measured: Baseline
Prevalence of Compassion Fatigue as measured by Professional Quality of Life 5 (ProQOL 5) scale
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Jul 2020
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,148 participants (actual)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor
- Investigators
- Fernanda L Setta, Principal investigator, D'Or Institute for Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846907
- Sponsor's protocol ID
- COVID-EMOTION
- Status last verified
- Jan 2022
- First submitted
- 13 Apr 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Oh N, Hong N, Ryu DH, Bae SG, Kam S, Kim KY. Exploring Nursing Intention, Stress, and Professionalism in Response to Infectious Disease Emergencies: The Experience of Local Public Hospital Nurses During the 2015 MERS Outbreak in South Korea. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Sep;11(3):230-236. doi: 10.1016/j.anr.2017.08.005. Epub 2017 Aug 21.
PubMed 28991605Almutairi AF, Adlan AA, Balkhy HH, Abbas OA, Clark AM. "It feels like I'm the dirtiest person in the world.": Exploring the experiences of healthcare providers who survived MERS-CoV in Saudi Arabia. J Infect Public Health. 2018 Mar-Apr;11(2):187-191. doi: 10.1016/j.jiph.2017.06.011. Epub 2017 Jul 1.
PubMed 28676285Roy D, Tripathy S, Kar SK, Sharma N, Verma SK, Kaushal V. Study of knowledge, attitude, anxiety & perceived mental healthcare need in Indian population during COVID-19 pandemic. Asian J Psychiatr. 2020 Jun;51:102083. doi: 10.1016/j.ajp.2020.102083. Epub 2020 Apr 8.
PubMed 32283510Chan AO, Huak CY. Psychological impact of the 2003 severe acute respiratory syndrome outbreak on health care workers in a medium size regional general hospital in Singapore. Occup Med (Lond). 2004 May;54(3):190-6. doi: 10.1093/occmed/kqh027.
PubMed 15133143Greenberg N, Docherty M, Gnanapragasam S, Wessely S. Managing mental health challenges faced by healthcare workers during covid-19 pandemic. BMJ. 2020 Mar 26;368:m1211. doi: 10.1136/bmj.m1211. No abstract available.
PubMed 32217624Chen Q, Liang M, Li Y, Guo J, Fei D, Wang L, He L, Sheng C, Cai Y, Li X, Wang J, Zhang Z. Mental health care for medical staff in China during the COVID-19 outbreak. Lancet Psychiatry. 2020 Apr;7(4):e15-e16. doi: 10.1016/S2215-0366(20)30078-X. Epub 2020 Feb 19. No abstract available.
PubMed 32085839Buckley L, Berta W, Cleverley K, Medeiros C, Widger K. What is known about paediatric nurse burnout: a scoping review. Hum Resour Health. 2020 Feb 11;18(1):9. doi: 10.1186/s12960-020-0451-8.
PubMed 32046721Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.
PubMed 32202646Wu PE, Styra R, Gold WL. Mitigating the psychological effects of COVID-19 on health care workers. CMAJ. 2020 Apr 27;192(17):E459-E460. doi: 10.1503/cmaj.200519. Epub 2020 Apr 15. No abstract available.
PubMed 32295761
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health and Emotional Aspects of Professionals Working in Pediatric Intensive Care Units During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04846907
- Acronym / sponsor ID
- COVID-EMOTION
- Conditions
- Covid19, Burnout, Professional, Stress Disorders, Post-Traumatic, Anxiety, Depression, Compassion Fatigue
- Keywords
- Covid19, Burnout, Post-Traumatic Stress Disorder, Anxiety, Depression, Compassion Fatigue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,148 participants (actual)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 15 Apr 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare personnel working in pediatric intensive care units during COVID-19 pandemic | – | Other: Web-based surveyPhysicians, registered nurses, nurse technicians, physical therapists and other professionals; on duty, routine staff or fellow/residents working in participants PICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physicians, registered nurses, nurse technicians, physical therapists and other professionals; on duty, routine staff or fellow/residents working in participants PICU
Key inclusion criteria (1 listed)
- Eligible participants that signed informed consent form
Key exclusion criteria (1 listed)
- Refused to sign informed consent form
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 |
|---|---|---|
| Web-based surveyEligible participants received emails or text messages with links to a REDCap-created and managed web-based questionnaire | Other | Healthcare personnel working in pediatric intensive care units during COVID-19 pandemic |
Primary outcome
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.
4 secondary outcomes
Prevalence of anxiety as measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
Prevalence of depression as measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
Prevalence of Post-traumatic Stress Disorder (PTSD) as measured by PTSD Checklist DSM-5 (PCL-5)
Time frame: Baseline
Prevalence of Compassion Fatigue as measured by Professional Quality of Life 5 (ProQOL 5) scale
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Background: PubMed 28991605Oh N, Hong N, Ryu DH, Bae SG, Kam S, Kim KY. Exploring Nursing Intention, Stress, and Professionalism in Response to Infectious Disease Emergencies: The Experience of Local Public Hospital Nurses During the 2015 MERS Outbreak in South Korea. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Sep;11(3):230-236. doi: 10.1016/j.anr.2017.08.005. Epub 2017 Aug 21.
- Background: PubMed 28676285Almutairi AF, Adlan AA, Balkhy HH, Abbas OA, Clark AM. "It feels like I'm the dirtiest person in the world.": Exploring the experiences of healthcare providers who survived MERS-CoV in Saudi Arabia. J Infect Public Health. 2018 Mar-Apr;11(2):187-191. doi: 10.1016/j.jiph.2017.06.011. Epub 2017 Jul 1.
- Background: PubMed 32283510Roy D, Tripathy S, Kar SK, Sharma N, Verma SK, Kaushal V. Study of knowledge, attitude, anxiety & perceived mental healthcare need in Indian population during COVID-19 pandemic. Asian J Psychiatr. 2020 Jun;51:102083. doi: 10.1016/j.ajp.2020.102083. Epub 2020 Apr 8.
- Background: PubMed 15133143Chan AO, Huak CY. Psychological impact of the 2003 severe acute respiratory syndrome outbreak on health care workers in a medium size regional general hospital in Singapore. Occup Med (Lond). 2004 May;54(3):190-6. doi: 10.1093/occmed/kqh027.
- Background: PubMed 32217624Greenberg N, Docherty M, Gnanapragasam S, Wessely S. Managing mental health challenges faced by healthcare workers during covid-19 pandemic. BMJ. 2020 Mar 26;368:m1211. doi: 10.1136/bmj.m1211. No abstract available.
- Background: PubMed 32085839Chen Q, Liang M, Li Y, Guo J, Fei D, Wang L, He L, Sheng C, Cai Y, Li X, Wang J, Zhang Z. Mental health care for medical staff in China during the COVID-19 outbreak. Lancet Psychiatry. 2020 Apr;7(4):e15-e16. doi: 10.1016/S2215-0366(20)30078-X. Epub 2020 Feb 19. No abstract available.
- Background: PubMed 32046721Buckley L, Berta W, Cleverley K, Medeiros C, Widger K. What is known about paediatric nurse burnout: a scoping review. Hum Resour Health. 2020 Feb 11;18(1):9. doi: 10.1186/s12960-020-0451-8.
- Background: PubMed 32202646Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.
- Background: PubMed 32295761Wu PE, Styra R, Gold WL. Mitigating the psychological effects of COVID-19 on health care workers. CMAJ. 2020 Apr 27;192(17):E459-E460. doi: 10.1503/cmaj.200519. Epub 2020 Apr 15. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Fernanda L Setta principal investigator
D'Or Institute for Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Burnout, Professional, run by D'Or Institute for Research and Education 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 1 inclusion and 1 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 13 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of burnout as measured by Maslach Burnout Inventory (MBI) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04846907, which also lists 9 linked publications.
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 13 Jan 2022.