- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05246124
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
East Java
-
Surabaya, East Java, Indonesia, 67161
- Dr. Soetomo General Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
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
|
|
Ingen inngripen: Control group
No intervention during 2-week self-isolation period
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
State-Trait Anxiety Inventory (STAI)
Tidsramme: 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
|
2 weeks
|
|
Brief Resiliency Scale (BRS)
Tidsramme: 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
|
2 weeks
|
|
Maslach Burnout Inventory (MBI)
Tidsramme: 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
|
2 weeks
|
|
Cortisol
Tidsramme: 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 |
2 weeks
|
|
CD4
Tidsramme: 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.
|
2 weeks
|
|
Interleukin-6 (IL-6)
Tidsramme: 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.
|
2 weeks
|
|
Neutrophil to lymphocyte ratio (NLR)
Tidsramme: 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.
|
2 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Margarita M Maramis, MD, Ph.D, Dr. Soetomo General Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0006/KEPK/V/2020
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .