NCT04846907

Brief 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. 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.

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
1,148

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

April 13, 2021

Last Update Submit

January 11, 2022

Conditions

Keywords

Covid19BurnoutPost-Traumatic Stress DisorderAnxietyDepressionCompassion Fatigue

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (4)

  • Prevalence of anxiety as measured by Hospital Anxiety and Depression Scale (HADS)

    Baseline

  • Prevalence of depression as measured by Hospital Anxiety and Depression Scale (HADS)

    Baseline

  • Prevalence of Post-traumatic Stress Disorder (PTSD) as measured by PTSD Checklist DSM-5 (PCL-5)

    Baseline

  • Prevalence of Compassion Fatigue as measured by Professional Quality of Life 5 (ProQOL 5) scale

    Baseline

Study Arms (1)

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

Interventions

Eligible participants received emails or text messages with links to a REDCap-created and managed web-based questionnaire

Healthcare personnel working in pediatric intensive care units during COVID-19 pandemic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Eligible participants that signed informed consent form

You may not qualify if:

  • Refused to sign informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

D'Or Institute for Research and Education

Rio de Janeiro, 22281-100, Brazil

Location

Related Publications (9)

  • 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.

    PMID: 28991605BACKGROUND
  • Almutairi 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.

    PMID: 28676285BACKGROUND
  • Roy 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.

    PMID: 32283510BACKGROUND
  • Chan 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.

    PMID: 15133143BACKGROUND
  • Greenberg 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.

    PMID: 32217624BACKGROUND
  • Chen 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.

    PMID: 32085839BACKGROUND
  • Buckley 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.

    PMID: 32046721BACKGROUND
  • Lai 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.

    PMID: 32202646BACKGROUND
  • Wu 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.

    PMID: 32295761BACKGROUND

MeSH Terms

Conditions

COVID-19Burnout, ProfessionalStress Disorders, Post-TraumaticAnxiety DisordersDepressionCompassion FatigueBurnout, Psychological

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOccupational StressOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersMental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fernanda L Setta

    D'Or Institute for Research and Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 15, 2021

Study Start

July 1, 2020

Primary Completion

July 1, 2022

Study Completion

December 1, 2022

Last Updated

January 13, 2022

Record last verified: 2022-01

Locations