- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05554029
Coronaphobia in Rheumatic Diseases
September 21, 2022 updated by: Songul Baglan Yentur, Gazi University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Songul B Yentur
- Phone Number: +90 424 2370000
- Email: songulbaglan23@hotmail.com
Study Contact Backup
- Name: Songul B Yentur
Study Locations
-
-
-
Ankara, Turkey, 06560
- Recruiting
- Songul Baglan Yentur
-
Contact:
- Songul B Yentur
- Phone Number: +90 424 2370000
- Email: songulbaglan23@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between the ages of 18 to 65
- Have diagnosed with Romatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erthematosus or Fibromyalgia
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
Patients with rheumatic diseases
|
Coronophobia will be assessed with COVID-19-phobia scale.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Anxiety and Depression Scale
Time Frame: 3 minutes
|
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
|
3 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Songul B Yentur, Gazi University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 25, 2022
Primary Completion (Anticipated)
November 20, 2022
Study Completion (Anticipated)
December 20, 2022
Study Registration Dates
First Submitted
September 21, 2022
First Submitted That Met QC Criteria
September 21, 2022
First Posted (Actual)
September 26, 2022
Study Record Updates
Last Update Posted (Actual)
September 26, 2022
Last Update Submitted That Met QC Criteria
September 21, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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