Coronaphobia in Rheumatic Diseases
Primary Purpose
Rheumatic Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Coronaphobia
Sponsored by
About this trial
This is an interventional health services research trial for Rheumatic Diseases focused on measuring coronaphobia, Rheumatic diseases, COVID-19
Eligibility Criteria
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
Sites / Locations
- Songul Baglan YenturRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
Patients with rheumatic diseases
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05554029
First Posted
September 21, 2022
Last Updated
September 21, 2022
Sponsor
Gazi University
Collaborators
Firat University
1. Study Identification
Unique Protocol Identification Number
NCT05554029
Brief Title
Coronaphobia in Rheumatic Diseases
Official Title
Coronaphobia in Rheumatic Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2022 (Anticipated)
Primary Completion Date
November 20, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
Collaborators
Firat University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Diseases
Keywords
coronaphobia, Rheumatic diseases, COVID-19
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Patients with rheumatic diseases
Intervention Type
Diagnostic Test
Intervention Name(s)
Coronaphobia
Intervention Description
Coronophobia will be assessed with COVID-19-phobia scale.
Primary Outcome Measure Information:
Title
Covid-19 Phobia Scale
Description
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.
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Description
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
Time Frame
3 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songul B Yentur
Phone
+90 424 2370000
Email
songulbaglan23@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Songul B Yentur
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Songul B Yentur
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Songul Baglan Yentur
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songul B Yentur
Phone
+90 424 2370000
Email
songulbaglan23@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Coronaphobia in Rheumatic Diseases
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