Rheumatic DiseasesNCT05554029
Coronaphobia in Rheumatic Diseases
A study testing Coronaphobia in people with Rheumatic Diseases, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
COVID-19 is a contagious respiratory disease that is caused Severe Acute Respiratory Syndrome causing Coronavirus-2 (SARS-CoV-2). The most common symptoms are fever, cough and dyspnoea. Patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Coronaphobia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2022to 20 Dec 2022
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 to 65
- Have diagnosed with Romatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erthematosus or Fibromyalgia
Who cannot join
- Being pregnant
- Diagnosed with malignancy
- Had changes of medical treatment in the last 3 months
- Had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits
Trial locations and contacts
1 site in 1 country.
Songul B Yentur contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Songul Baglan Yentur
Ankara, 06560
Songul B Yentur, +90 424 2370000, songulbaglan23@hotmail.com
About this study
COVID-19 is a contagious respiratory disease that is caused Severe Acute Respiratory Syndrome causing Coronavirus-2 (SARS-CoV-2). The most common symptoms are fever, cough and dyspnoea. Patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression. In addition, old age and having concomitant chronic disease are among risk factors for coronavirus. Therefore, national health services recommend patients to practice self-isolation and self-quarantine.
Read the detailed description
COVID-19 is a contagious respiratory disease that is caused Severe Acute Respiratory Syndrome causing Coronavirus-2 (SARS-CoV-2). It was firstly seen in December 2019 in Wuhan, China and spread rapidly all over the world. World Health Organization (WHO) was declared COVID-19 as a pandemic in March 2020. The most common symptoms are fever, cough and dyspnoea. Social isolation and staying home have been suggested to reduce the spreading rate of COVID-19 pandemic in many countries. In addition, curfew except necessity was applied in some countries and time of curfew varied by country. Therefore, pandemic caused changes in routine life for millions of people. Patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression. In addition, old age and having concomitant chronic disease are among risk factors for coronavirus. Therefore, national health services recommend patients to practice self-isolation and self-quarantine. However, social isolation was concluded with more increased physical inactivity and sedentary lifestyle. The aim of this study is to investigate coronaphobia in rheumatic diseases and compare with healthy people.
- Conditions
- Rheumatic Diseases
- Being tested
- Coronaphobia
- Keywords
- coronaphobia, Rheumatic diseases, COVID-19
- Medical subject headings
- Rheumatic Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoronaphobiaDiagnostic test
Coronophobia will be assessed with COVID-19-phobia scale.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients with rheumatic diseases Receives: Diagnostic Test: Coronaphobia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Covid-19 Phobia Scale
Covid-19 Phobia Scale (C19P-S) was developed by Arpaci et al. C19P-S is a self-reported questionnaire consisting of 20 items and four, i.e., psychological, psychosomatic, economic, and social, subscales. All items are rated on a 5-point scale from "strongly disagree" to "strongly agree". The total score ranges from 20 to 100 points;,the higher the score, the higher is the level of coronaphobia.
Measured: 2 minutes
Secondary outcomes (1)
Hospital Anxiety and Depression Scale
It consists of 14 questions that which 7 of them evaluate depression and 7 of them evaluate anxiety. Each question is scored from 0 to 3 and high scores indicate severe anxiety and depression
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start25 Sep 2022 (estimated)
- Primary completion20 Nov 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Firat University
- Responsible party
- Principal investigator, Songul Baglan Yentur, Firat University
- Investigators
- Songul B Yentur, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554029
- Sponsor's protocol ID
- 15-23
- Status last verified
- Sep 2022
- First submitted
- 21 Sep 2022
- Last updated
- 26 Sep 2022
- 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 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronaphobia in Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT05554029
- Acronym / sponsor ID
- 15-23
- Conditions
- Rheumatic Diseases
- Keywords
- coronaphobia, Rheumatic diseases, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Firat University
- Study start
- 25 Sep 2022 (estimated)
- Primary completion
- 20 Nov 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 26 Sep 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.
COVID-19 is a contagious respiratory disease that is caused Severe Acute Respiratory Syndrome causing Coronavirus-2 (SARS-CoV-2). The most common symptoms are fever, cough and dyspnoea. Patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression. In addition, old age and having concomitant chronic disease are among risk factors for coronavirus. Therefore, national health services recommend patients to practice self-isolation and self-quarantine.
Detailed description
COVID-19 is a contagious respiratory disease that is caused Severe Acute Respiratory Syndrome causing Coronavirus-2 (SARS-CoV-2). It was firstly seen in December 2019 in Wuhan, China and spread rapidly all over the world. World Health Organization (WHO) was declared COVID-19 as a pandemic in March 2020. The most common symptoms are fever, cough and dyspnoea. Social isolation and staying home have been suggested to reduce the spreading rate of COVID-19 pandemic in many countries. In addition, curfew except necessity was applied in some countries and time of curfew varied by country. Therefore, pandemic caused changes in routine life for millions of people. Patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression. In addition, old age and having concomitant chronic disease are among risk factors for coronavirus. Therefore, national health services recommend patients to practice self-isolation and self-quarantine. However, social isolation was concluded with more increased physical inactivity and sedentary lifestyle. The aim of this study is to investigate coronaphobia in rheumatic diseases and compare with healthy people.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Diagnostic Test: CoronaphobiaPatients with rheumatic diseases |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between the ages of 18 to 65
- Have diagnosed with Romatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erthematosus or Fibromyalgia
Key exclusion criteria (4 listed)
- Being pregnant
- Diagnosed with malignancy
- Had changes of medical treatment in the last 3 months
- Had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits
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 |
|---|---|---|
| CoronaphobiaCoronophobia will be assessed with COVID-19-phobia scale. | Diagnostic test | Study group |
Primary outcome
Covid-19 Phobia Scale
Time frame: 2 minutes
Covid-19 Phobia Scale (C19P-S) was developed by Arpaci et al. C19P-S is a self-reported questionnaire consisting of 20 items and four, i.e., psychological, psychosomatic, economic, and social, subscales. All items are rated on a 5-point scale from "strongly disagree" to "strongly agree". The total score ranges from 20 to 100 points;,the higher the score, the higher is the level of coronaphobia.
1 secondary outcome
Hospital Anxiety and Depression Scale
Time frame: 3 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- 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.
Songul B Yentur contact
Songul B Yentur principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronaphobia in people with Rheumatic Diseases, run by Gazi 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 2 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 26 Sep 2022. 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 Songul B Yentur (+90 424 2370000, songulbaglan23@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Covid-19 Phobia Scale (time frame: 2 minutes). 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 26 Sep 2022.