NCT05246124

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

19 days

First QC Date

February 15, 2022

Last Update Submit

February 20, 2022

Conditions

Burnout, PsychologicalAnxiety

Keywords

Mental healthCOVID-19Healthcare workersAnxietyBurnoutBiomarkers

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (2)

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

Other: Zumba dance exercise

Control group

NO INTERVENTION

No intervention during 2-week self-isolation period

Interventions

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

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Soetomo General Hospital

Surabaya, East Java, 67161, Indonesia

Location

MeSH Terms

Conditions

Burnout, PsychologicalAnxiety DisordersPsychological Well-BeingCOVID-19

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorMental DisordersPersonal SatisfactionPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Margarita M Maramis, MD, Ph.D

    Dr. Soetomo General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2022

First Posted

February 18, 2022

Study Start

May 25, 2020

Primary Completion

June 13, 2020

Study Completion

June 13, 2020

Last Updated

February 22, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)