The Effect of Demographic, Mental, and Physical Activity Profiles Towards Burnout in Frontline Healthcare Workers Facing COVID-19 Pandemics in Dr. Soetomo General Hospital Surabaya

The Effect of Demographic, Mental, and Physical Activity Profiles Towards Burnout in Frontline Healthcare Workers Facing COVID-19 Pandemics in RSUD Dr. Soetomo Surabaya

This was a randomized controlled trial study to measure the effect of intervention of Zumba dance towards psychological and biological markers in hospital residents managing COVID-19 patients

Study Overview

• Status: Completed
• Conditions: Burnout, Psychological; Anxiety
• Intervention / Treatment: Other: Zumba dance exercise

Detailed Description

A study to compare the effect of Zumba dance exercise towards psychological and biological markers in control and intervention groups of residents managing COVID-19 patients. Psychological markers were assessed using State Trait Anxiety Inventory (STAI), Brief Resilience Scale (BRS), and Maslach Burnout Inventory (MBI) questionnaires. Biological markers being measured were neutrophil to lymphocyte ratio (NLR), CD4, Interleukin-6 (IL-6), and salivary cortisol. Measurements were done at the beginning of self-isolation after shift and 2 weeks after self-isolation.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • East Java
    • Surabaya, East Java, Indonesia, 67161
      • Dr. Soetomo General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Residents of anesthesiology and internal medicine department at Dr. Soetomo General Hospital Surabaya
• Residents managing COVID-19 patients in the special isolation room

Exclusion Criteria:

• Residents that did not fill in the questionnaires completely
• Residents with comorbidities (diabetes, hypertension, heart disease or autoimmune disorders)
• Residents that were infected with COVID-19
• Residents currently or previously diagnosed with psychosis
• Residents refusing to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; This study used Zumba dance exercise done 3 times a week during 2-week self-isolation period, with each session lasting for 50 minutes. The participants did exercise by following instructions from Zumba video shown	Other: Zumba dance exercise; The intervention was Zumba dance done 3 times a week during the 2-week self-isolation period, with each session lasting for 50 minutes. The participants did exercise by following instructions from Zumba video shown
No Intervention: Control group; No intervention during 2-week self-isolation period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Inventory (STAI)	State anxiety (STAI-S) is the presence subjective feeling of fear and tension, also the occurrence of autonomic nervous activation responding to dangerous or threatening condition. Trait anxiety (STAI-T) is a more stable aspect of tendency towards anxiety, including calmness, self-esteem, and feeling secure. STAI contains 40 statements with the score interpretation ranging from 20-80. The score between 20-37 means having low or no anxiety, 38-44 indicates medium anxiety, and 45-80 suggests high anxiety	2 weeks
Brief Resiliency Scale (BRS)	BRS consists of six questions, with three positive statements and three negative statements. Participants choose one of the five responses to the statements, ranging from "strongly disagree" to "strongly agree". There are three categories of results: low	2 weeks
Maslach Burnout Inventory (MBI)	The MBI scoring is divided into dimensions of burnout such as emotional exhaustion (EE), depersonalization (DP), and personal accomplishment (PA). The 22-items questionnaire evaluates these domains of burnout, containing 9 items for emotional exhaustion (MBI-EE), 5 items for depersonalization (MBI-DP), and 8 items for personal accomplishment (MBI-PA). Each item is rated using a Likert scale, measuring the experience of the participants, ranging from never (0) to everyday (6). The MBI-EE score consists of high for total score ≥ 30, moderate for 18-28, and low for ≤ 17. The MBI-DP score comprises high for total score ≥ 12, moderate for 6-11, and low for ≤ 5. As for the MBI-PA, it is considered low for a total score ≤ 33, moderate for 34-39, and high for ≥ 40	2 weeks
Cortisol	Unstimulated saliva samples, using the passive drooling method, were collected from each participant. The participants should not eat or drink anything at least 1 hour prior to the saliva collection. Also, the participants were instructed to brush their teeth and wash their oral cavities with sterilized water. Samples were kept cold using cooler box and transported to the laboratory. In the laboratory, samples were immediately centrifuged 1700xg at 4°C for 10 minutes within one hour after collection, Samples were aliquoted and stored at -80°C for further analysis of cortisol level. Determination of saliva cortisol was performed using a cortisol enzyme immunoassay kit. Samples (25 µL) were treated according to the manufacturer's instructions. The optical density of the samples and standards were measured at a wavelength of 450 nm by a microplate reader	2 weeks
CD4	5 ml blood samples were collected from median cubital vein using a standardized venipuncture technique in EDTA tube for CD4 analysis. Blood samples were centrifuged 2500 rpm for 15 minutes. The serum were then aliquoted and stored at -80°C. CD4 were analyzed by flowcytometry according to the manufacturer's instruction.	2 weeks
Interleukin-6 (IL-6)	5 ml blood samples were collected from median cubital vein using a standardized venipuncture technique in serum separator tube (SST) for Interleukin 6. Blood samples were centrifuged 2500 rpm for 15 minutes. The serum were then aliquoted and stored at -80°C. Quantification of Interleukin-6 used commercial ELISA kit according to the manufacturer's instructions. The optical density of the samples and standards were measured by a microplate reader. Samples' concentration was calculated according to the relevant standard curve.	2 weeks
Neutrophil to lymphocyte ratio (NLR)	5 ml blood samples were collected from median cubital vein using a standardized venipuncture technique in EDTA tube for NLR analysis. NLR were analyzed by flowcytometry according to the manufacturer's instruction.	2 weeks

Collaborators and Investigators

• Sponsor: Dr. Soetomo General Hospital
• Collaborators: Universitas Airlangga
• Investigators: Principal Investigator: Margarita M Maramis, MD, Ph.D, Dr. Soetomo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Actual): June 13, 2020
• Study Completion (Actual): June 13, 2020

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 20, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Anxiety; COVID-19; Biomarkers; Mental health; Burnout; Healthcare workers
• Additional Relevant MeSH Terms: Behavioral Symptoms; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Stress, Psychological; COVID-19; Burnout, Psychological
• Other Study ID Numbers: 0006/KEPK/V/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No