Coronaphobia in Rheumatic Diseases | NCT05554029

Studies
Coronaphobia in Rheumatic Diseases

NCT05554029

Sponsor

Gazi University

Status

Unknown status

Last Update Posted

Sep 26, 2022Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Rheumatic Diseases

Interventions

Coronaphobia

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2022Estimated

Primary Completion Date

Nov 20, 2022Estimated

Completion Date

Dec 20, 2022Estimated

First Submitted Date

Sep 21, 2022

First Submission Date that Met QC Criteria

Sep 21, 2022

First Posted Date

Sep 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2022

Last Update Posted Date

Sep 26, 2022Actual

Name	Class
Firat University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	Patients with rheumatic diseases	Diagnostic Test: Coronaphobia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coronaphobia	Diagnostic Test	Coronophobia will be assessed with COVID-19-phobia scale.	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	2 minutes

Secondary Outcomes

Measure	Description	Time Frame
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	3 minutes

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Songul B Yentur	Contact	+90 424 2370000		songulbaglan23@hotmail.com
Songul B Yentur	Contact

Overall Officials

Name	Affiliation	Role
Songul B Yentur	Gazi University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Songul Baglan Yentur	Recruiting	Ankara		06560	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012216	Rheumatic Diseases
D000086382	COVID-19

Ancestor Terms

ID	Term
D009140	Musculoskeletal Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D011024	Pneumonia, Viral

Browse Leaves

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Browse Branches

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