- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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East Java
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Surabaya, East Java, Indonésie, 67161
- Dr. Soetomo General Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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
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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
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Aucune intervention: Control group
No intervention during 2-week self-isolation period
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
State-Trait Anxiety Inventory (STAI)
Délai: 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
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2 weeks
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Brief Resiliency Scale (BRS)
Délai: 2 weeks
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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)
Délai: 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
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2 weeks
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Cortisol
Délai: 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
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CD4
Délai: 2 weeks
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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.
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2 weeks
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Interleukin-6 (IL-6)
Délai: 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.
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2 weeks
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Neutrophil to lymphocyte ratio (NLR)
Délai: 2 weeks
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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.
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2 weeks
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Margarita M Maramis, MD, Ph.D, Dr. Soetomo General Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Symptômes comportementaux
- Infections à coronavirus
- Infections à Coronaviridae
- Infections à Nidovirales
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Pneumonie virale
- Pneumonie
- Maladies pulmonaires
- Stress, Psychologique
- COVID-19 [feminine]
- Burnout, Psychologique
Autres numéros d'identification d'étude
- 0006/KEPK/V/2020
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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