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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04846907
• Other study ID #: COVID-EMOTION
• Status: Active, not recruiting
• Start date: July 1, 2020
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: D'Or Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1148
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eligible participants that signed informed consent form

Exclusion Criteria:

• Refused to sign informed consent form

Related Conditions & MeSH terms

• Anxiety
• Burnout, Professional
• Burnout, Psychological
• Compassion Fatigue
• COVID-19
• Covid19
• Depression
• Fatigue
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Web-based survey
Eligible participants received emails or text messages with links to a REDCap-created and managed web-based questionnaire

Locations

Country	Name	City	State
Brazil	D'Or Institute for Research and Education	Rio De Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Erratum in: Lancet Psychiatry. 2020 May;7(5):e27. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline