Psychological DistressNCT05503589
The Psychological Effect of the Covid-19 Pandemic
An observational study of Psychological Distress, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 30 Apr 2021
- Phase
- Observational
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: intern students at the Faculty of Health Sciences of Kutahya Health Sciences University
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University- Health Sciences Faculty
Kütahya, Kütahya, 43000
About this study
Official title: The Psychological Effect of the Covid-19 Pandemic on Turkish Intern Students
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.
- Conditions
- Psychological Distress
- Keywords
- psychological distress, Covid-19, saliva cortisol
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| student group | have taken the professional practice/internship lecture and be practicing in the hospital | |
| control group | who routinely work during the pandemic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Mar 2021
- Primary completion26 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Kurt, Kutahya Health Sciences University
- Investigators
- Gamze KURT, Ph.D., Principal investigator, Kutahya Health Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503589
- Sponsor's protocol ID
- Covid-saliva
- Status last verified
- Mar 2025
- First submitted
- 15 Aug 2022
- Last updated
- 6 Mar 2025
- 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psychological Effect of the Covid-19 Pandemic on Turkish Intern Students
- ClinicalTrials.gov ID
- NCT05503589
- Acronym / sponsor ID
- Covid-saliva
- Conditions
- Psychological Distress
- Keywords
- psychological distress, Covid-19, saliva cortisol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 16 Aug 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| student group | – | –have taken the professional practice/internship lecture and be practicing in the hospital |
| control group | – | –who routinely work during the pandemic |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- intern students at the Faculty of Health Sciences of Kutahya Health Sciences University
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Fear of Covid-19 Scale
Time frame: 5 minutes
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.
Depression Anxiety and Stress Scale
Time frame: 10 minutes
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.
Saliva cortisol level
Time frame: 15 minutes
The solid-phase sandwich ELISA (Enzyme Linked-Immuno-Sorbent Assay) method was used with immunoassay kits to measure the cortisol level.
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 6 Mar 2025.
- 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.
Gamze KURT, Ph.D. principal investigator
Kutahya Health Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Distress, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 7 inclusion and 3 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 6 Mar 2025. 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 Turkey (Türkiye). 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?
The Fear of Covid-19 Scale (time frame: 5 minutes). The study lists 3 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 6 Mar 2025.