The coronavirus outbreak has adversely affected individuals in the community, as in the rest of the world. However, in order to carry out this epidemic period in a healthy and conscious manner, determining the anxiety levels of individuals in the society and supporting them psychologically is of great importance. In order to achieve this, healthcare professionals working clinically or academically have important duties. This study was planned to test its validity and reliability in order to adapt the Coronavirus Anxiety Scale to Turkish.

Read the detailed description

Coronaviruses can be seen in animals and humans as infections that can be mild and severe in society. The SARS-CoV-2 virus, a type of coronavirus, started in China in December 2019 and has spread worldwide as of January 2020. The absence of vaccine and treatment for SARS-CoV-2 disease threatens health worldwide and significantly affects people's daily routine. In China, where the pandemic started, shopping malls and schools were closed for a while, and city entrances and exits were stopped for a while. Although there are similar practices in excellence, as in many countries, measures such as curfew, nursery and school closure continue to be taken for under-20s and over-65s. . The coronavirus epidemic that affects our entire life is not fully known about the disease process, WHO is defined as the pandemic of the epidemic, the nearest contact is the greatest risk of transmission, and the loss of many lives during this process affects all individuals in the society negatively and increases the level of anxiety .

It is a psychological reaction involving many emotions such as anxiety, stress, or anxiety, fear and distress that arise in a situation that threatens the safety of the individual. Conditions such as uncertainty, various diseases (cancer, epidemic, etc.) and losing a relative can cause anxiety. Outbreaks that occur suddenly and are at risk of death are among these reasons.

Conditions: Anxiety, SARS-CoV Infection
Being tested: survey work
Keywords: Coronavirus Anxiety Scale, COVID-19, Anxiety
Medical subject headings: Anxiety Disorders, Severe Acute Respiratory Syndrome, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

survey workOther
Survey forms will be sent to individuals online. Information about the study will be given to individuals with the informative text at the beginning of the questionnaire form. Individuals who agree to participate in the study will fill in the questionnaire and send it back online.

Study groups in NCT04490473
Study group	Role	What they receive
volunteer group	Other	Only volunteer participants will be included in the research. Survey forms will be sent to individuals online. Individuals who agree to participate in the study will fill in the questionnaire and send it back online. Receives: Other: survey work

What is being measured

The primary outcome is the main question the study is designed to answer.

Anxiety in SARS-CoV-2
anxiety increase in SARS-CoV-2 in humans.
Measured: 4 weeks
Ratio of SARS-CoV-2 anxiety scale to beck anxiety scale
The ratio of SARS-CoV-2 anxiety scale to beck anxiety scale is similar.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jul 202024 Apr 2021

First posted29 Jul 2020
Study start24 Jul 2020
Primary completion24 Mar 2021 (estimated)
Study completion24 Apr 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: This research will be conducted in a methodological manner in order to conduct the validity and reliability studies of the Coronary Virus Anxiety Scale in Turkish.
Masking: None (open label)
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04490473
Sponsor's protocol ID: DSAYIK2
Other IDs: Ayfer AÇIKGÖZ, ERTUĞRUL ÇOLAK, DENİZ YİĞİT, ÖZLEM MUMCU
Status last verified: Dec 2020
First submitted: 25 Jul 2020
Last updated: 23 Dec 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: It is planned to be published in the journal after the study is completed. The study will be shared with other researchers after it is published in the journal.

Publications

Benli, S. S., & Yıldırım, A. (2017). Hemşirelerde yaşam doyumu ve ölüme karşı tutum arasındaki ilişki. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi, 6(4), 167-179
Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
PubMed 3204199
Chen P, Mao L, Nassis GP, Harmer P, Ainsworth BE, Li F. Coronavirus disease (COVID-19): The need to maintain regular physical activity while taking precautions. J Sport Health Sci. 2020 Mar;9(2):103-104. doi: 10.1016/j.jshs.2020.02.001. Epub 2020 Feb 4. No abstract available.
PubMed 32099716
Chen Y, Liu Q, Guo D. Emerging coronaviruses: Genome structure, replication, and pathogenesis. J Med Virol. 2020 Apr;92(4):418-423. doi: 10.1002/jmv.25681. Epub 2020 Feb 7.
PubMed 31967327
Faraji A, Karimi M, Azizi SM, Janatolmakan M, Khatony A. Occupational stress and its related demographic factors among Iranian CCU nurses: a cross-sectional study. BMC Res Notes. 2019 Sep 27;12(1):634. doi: 10.1186/s13104-019-4674-5.
PubMed 31558161
Lee SA. Coronavirus Anxiety Scale: A brief mental health screener for COVID-19 related anxiety. Death Stud. 2020;44(7):393-401. doi: 10.1080/07481187.2020.1748481. Epub 2020 Apr 16.
PubMed 32299304

Want to know more?

DILEK SAYIK

5065416642

dileksayik@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Turkish Validity And Reliability of the SARS-CoV-2 Anxiety Scale
ClinicalTrials.gov ID: NCT04490473
Acronym / sponsor ID: DSAYIK2
Conditions: Anxiety, SARS-CoV Infection
Keywords: Coronavirus Anxiety Scale, COVID-19, Anxiety
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 300 participants (estimated)
Lead sponsor: DILEK SAYIKUniversity, hospital or other
Study start: 24 Jul 2020 (actual)
Primary completion: 24 Mar 2021 (estimated)
Study completion: 24 Apr 2021 (estimated)
First posted: 29 Jul 2020 (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.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This research will be conducted in a methodological manner in order to conduct the validity and reliability studies of the Coronary Virus Anxiety Scale in Turkish.

Arm	Type	Receives
volunteer group	Other	Other: survey workOnly volunteer participants will be included in the research. Survey forms will be sent to individuals online. Individuals who agree to participate in the study will fill in the questionnaire and send it back online.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

individuals agree to participate in the study
18 years old,
Lack of visual obstacle,
Knowing how to speak, read and write in Turkish.

Key exclusion criteria (4 listed)

individuals refuse to participate in the study
18 years old,
Visually impaired,
Does not know how to speak, read and write in Turkish

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
survey workSurvey forms will be sent to individuals online. Information about the study will be given to individuals with the informative text at the beginning of the questionnaire form. Individuals who agree to participate in the study will fill in the questionnaire and send it back online.	Other	volunteer group

Primary outcome

Anxiety in SARS-CoV-2
Time frame: 4 weeks
anxiety increase in SARS-CoV-2 in humans.
Ratio of SARS-CoV-2 anxiety scale to beck anxiety scale
Time frame: 4 weeks
The ratio of SARS-CoV-2 anxiety scale to beck anxiety scale is similar.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
BackgroundBenli, S. S., & Yıldırım, A. (2017). Hemşirelerde yaşam doyumu ve ölüme karşı tutum arasındaki ilişki. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi, 6(4), 167-179
Background: PubMed 3204199Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
Background: PubMed 32099716Chen P, Mao L, Nassis GP, Harmer P, Ainsworth BE, Li F. Coronavirus disease (COVID-19): The need to maintain regular physical activity while taking precautions. J Sport Health Sci. 2020 Mar;9(2):103-104. doi: 10.1016/j.jshs.2020.02.001. Epub 2020 Feb 4. No abstract available.
Background: PubMed 31967327Chen Y, Liu Q, Guo D. Emerging coronaviruses: Genome structure, replication, and pathogenesis. J Med Virol. 2020 Apr;92(4):418-423. doi: 10.1002/jmv.25681. Epub 2020 Feb 7.
Background: PubMed 31558161Faraji A, Karimi M, Azizi SM, Janatolmakan M, Khatony A. Occupational stress and its related demographic factors among Iranian CCU nurses: a cross-sectional study. BMC Res Notes. 2019 Sep 27;12(1):634. doi: 10.1186/s13104-019-4674-5.
Background: PubMed 32299304Lee SA. Coronavirus Anxiety Scale: A brief mental health screener for COVID-19 related anxiety. Death Stud. 2020;44(7):393-401. doi: 10.1080/07481187.2020.1748481. Epub 2020 Apr 16.
Individual participant dataSharing planned: Yes. It is planned to be published in the journal after the study is completed. The study will be shared with other researchers after it is published in the journal.

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Femoral Arterial Sheath Removal, Stress Ball
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Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
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Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
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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.

DILEK SAYIK contact

5065416642

dileksayik@hotmail.com

DENIZ YIGIT contact

05428092848

yigitdenizyigit@gmail.com

DILEK SAYIK principal investigator

ESKISEHIR OSMANGAZI UNIVERSTY

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing survey work in people with Anxiety and SARS-CoV Infection, run by DILEK SAYIK 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Dec 2020. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact DILEK SAYIK (5065416642, dileksayik@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety in SARS-CoV-2 (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04490473, which also lists 6 linked publications.

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 23 Dec 2020.