NCT05503589

Brief Summary

At the end of 2019, the novel coronavirus disease (Covid-19), which emerged in China, has become a public health emergency of international concern. Disease outbreaks both affect the physical and psychological health of individuals. The aim of this study was to investigate the levels of stress, anxiety, depression, and Covid-19 fear in health sciences intern students during the Covid-19 pandemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

August 15, 2022

Last Update Submit

March 4, 2025

Conditions

Keywords

psychological distressCovid-19saliva cortisol

Outcome Measures

Primary Outcomes (3)

  • The Fear of Covid-19 Scale

    The Fear of Covid-19 Scale (FCV-19S) is an assessment instrument developed to measure the fear levels of individuals due to Covid-19. The scale consists of seven items in a five-point Likert type. The total score is calculated by summing seven items score (ranging from 7-35). The high scale score indicates great fear of Covid-19.

    5 minutes

  • Depression Anxiety and Stress Scale

    Depression Anxiety and Stress Scale (DASS) is a self-report scale that evaluates depression, anxiety, and stress state over the past week. The scale consists of a total of 42 items, with 14 items in each of the depression, anxiety and stress dimensions. DASS items have a four-point Likert-type rating.The total scores each dimension of the scale range from 0 to 42. The high scores each of the depression, anxiety and stress dimensions indicate that the individual has a related problem.

    10 minutes

  • Saliva cortisol level

    The solid-phase sandwich ELISA (Enzyme Linked-Immuno-Sorbent Assay) method was used with immunoassay kits to measure the cortisol level.

    15 minutes

Study Arms (2)

student group

have taken the professional practice/internship lecture and be practicing in the hospital

control group

who routinely work during the pandemic

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

intern students at the Faculty of Health Sciences of Kutahya Health Sciences University

You may qualify if:

  • be over 18 years old
  • have taken the professional practice/internship lecture
  • be practicing in the hospital
  • not have any disease
  • over the age of 18
  • without any disease
  • who routinely work during the pandemic

You may not qualify if:

  • body mass index (BMI) \<17 kg/m2
  • any chronic illness, psychological disorder, and perception problem
  • be dental operation or significant damage to the teeth or oral mucosa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University- Health Sciences Faculty

Kütahya, Kütahya, 43000, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

The unstimulated saliva samples of the participants were collected using the spitting method into the supplied polypropylene eppendorf tubes. Saliva samples collected in eppendorf tubes were centrifuged at 3,220 rpm for 10 minutes and stored at -20°C until the day of analysis.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Gamze KURT, Ph.D.

    Kutahya Health Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 16, 2022

Study Start

March 1, 2021

Primary Completion

April 26, 2021

Study Completion

April 30, 2021

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations