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
Primary Purpose
Burnout, Psychological, Anxiety
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Zumba dance exercise
Sponsored by
About this trial
This is an interventional prevention trial for Burnout, Psychological focused on measuring Mental health, COVID-19, Healthcare workers, Anxiety, Burnout, Biomarkers
Eligibility Criteria
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.
Sites / Locations
- Dr. Soetomo General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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
No intervention during 2-week self-isolation period
Outcomes
Primary Outcome Measures
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
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
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
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
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05246124
First Posted
February 15, 2022
Last Updated
February 20, 2022
Sponsor
Dr. Soetomo General Hospital
Collaborators
Universitas Airlangga
1. Study Identification
Unique Protocol Identification Number
NCT05246124
Brief Title
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
Official Title
The Effect of Demographic, Mental, and Physical Activity Profiles Towards Burnout in Frontline Healthcare Workers Facing COVID-19 Pandemics in RSUD Dr. Soetomo Surabaya
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 25, 2020 (Actual)
Primary Completion Date
June 13, 2020 (Actual)
Study Completion Date
June 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Soetomo General Hospital
Collaborators
Universitas Airlangga
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Psychological, Anxiety
Keywords
Mental health, COVID-19, Healthcare workers, Anxiety, Burnout, Biomarkers
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention during 2-week self-isolation period
Intervention Type
Other
Intervention Name(s)
Zumba dance exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI)
Description
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
Time Frame
2 weeks
Title
Brief Resiliency Scale (BRS)
Description
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
Time Frame
2 weeks
Title
Maslach Burnout Inventory (MBI)
Description
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
Time Frame
2 weeks
Title
Cortisol
Description
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
Time Frame
2 weeks
Title
CD4
Description
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.
Time Frame
2 weeks
Title
Interleukin-6 (IL-6)
Description
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.
Time Frame
2 weeks
Title
Neutrophil to lymphocyte ratio (NLR)
Description
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.
Time Frame
2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarita M Maramis, MD, Ph.D
Organizational Affiliation
Dr. Soetomo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Soetomo General Hospital
City
Surabaya
State/Province
East Java
ZIP/Postal Code
67161
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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