Burnout, PsychologicalNCT05246124
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
A study testing Zumba dance exercise in people with Burnout, Psychological and Anxiety, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
Trial 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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout, Psychological, Anxiety
- What is being tested?
- Zumba dance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 May 2020to 13 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residents of anesthesiology and internal medicine department at Dr. Soetomo General Hospital Surabaya
- Residents managing COVID-19 patients in the special isolation room
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Burnout, Psychological, Anxiety
- Being tested
- Zumba dance exercise
- Keywords
- Mental health, COVID-19, Healthcare workers, Anxiety, Burnout, Biomarkers
- Medical subject headings
- Burnout, Psychological, Anxiety Disorders, Psychological Well-Being, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zumba dance exerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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 Receives: Other: Zumba dance exercise |
| Control group | No intervention | No intervention during 2-week self-isolation period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start25 May 2020
- Primary completion13 Jun 2020
- Study completion13 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Collaborators
- Universitas Airlangga
- Responsible party
- Sponsor
- Investigators
- Margarita M Maramis, MD, Ph.D, Principal investigator, Dr. Soetomo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246124
- Sponsor's protocol ID
- 0006/KEPK/V/2020
- Status last verified
- Feb 2022
- First submitted
- 15 Feb 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05246124
- Acronym / sponsor ID
- 0006/KEPK/V/2020
- Conditions
- Burnout, Psychological, Anxiety
- Keywords
- Mental health, COVID-19, Healthcare workers, Anxiety, Burnout, Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Collaborators
- Universitas Airlangga
- Study start
- 25 May 2020 (actual)
- Primary completion
- 13 Jun 2020 (actual)
- Study completion
- 13 Jun 2020 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Zumba dance exerciseThis 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 |
| Control group | No intervention | –No intervention during 2-week self-isolation period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Residents of anesthesiology and internal medicine department at Dr. Soetomo General Hospital Surabaya
- Residents managing COVID-19 patients in the special isolation room
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zumba dance exerciseThe 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 | Other | Intervention group |
Primary outcome
State-Trait Anxiety Inventory (STAI)
Time frame: 2 weeks
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)
Time frame: 2 weeks
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)
Time frame: 2 weeks
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
Time frame: 2 weeks
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
Time frame: 2 weeks
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)
Time frame: 2 weeks
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)
Time frame: 2 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margarita M Maramis, MD, Ph.D principal investigator
Dr. Soetomo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zumba dance exercise in people with Burnout, Psychological and Anxiety, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (STAI) (time frame: 2 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.