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

Sponsor

D'Or Institute for Research and Education (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04846907

Collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)

1,148

Enrollment

Location

Anticipated Duration (Months)

39.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Burnout, Professional Stress Disorders, Post-Traumatic Anxiety Depression Compassion Fatigue	Other: Web-based survey

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

1148 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Prevalence of burnout as measured by Maslach Burnout Inventory (MBI) [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.

Secondary Outcome Measures

Prevalence of anxiety as measured by Hospital Anxiety and Depression Scale (HADS) [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.
Prevalence of depression as measured by Hospital Anxiety and Depression Scale (HADS) [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.
Prevalence of Post-traumatic Stress Disorder (PTSD) as measured by PTSD Checklist DSM-5 (PCL-5) [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.
Prevalence of Compassion Fatigue as measured by Professional Quality of Life 5 (ProQOL 5) scale [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.