The Effects of Covid-19 Pandemic on The Patients With Fibromyalgia

February 1, 2021 updated by: Damla Cankurtaran, Diskapi Yildirim Beyazit Education and Research Hospital

Investigation the Effect of Covid-19 Fear, Anxiety on Daily Life, Sleep Quality, and Anxiety-depression of the Patients With Fibromyalgia

The investigators planned to analyze the effect of Covid-19 fear and anxiety on the daily life, sleep quality and depression-anxiety levels of fibromyalgia patients.

Study Overview

Status

Unknown

Conditions

Detailed Description

Fibromyalgia; as a chronic syndrome of unknown cause with widespread body pain, fatigue, sleep disorder, cognitive impairment and anxiety. Many studies have shown a relationship between pain levels and anxiety levels in patients with fibromyalgia. Covid-19 started from Wuhan, China in December 2019 and spread worldwide. The rapid spread of this unexpected pandemic all over the world brought with it many conditions such as anxiety and stress disorders. It has been reported by experts that individuals with a predisposition to conditions such as anxiety and stress disorder in premorbidity require special attention.To evaluate the psychological effects of the Covid-19 pandemic, the Covid-19 anxiety scale was developed from Lee et al. and the Covid-19 fear scale was developed from Ahoursou et al. The investigators planned to analyzed the effect on Covid-19 fear and anxiety level on fibromyalgia patients' daily life with revised Fibromyalgia Impact questionnaire, sleep quality with Pittsburgh Sleep Quality Index, and anxiety-depression level with The Hospital Anxiety and Depression scale. This study was planned as a cross-sectional case control study.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altındag
      • Ankara, Altındag, Turkey, 06300
        • Recruiting
        • Diskapi Education and Research Hospital
        • Contact:

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

Sampling Method

Probability Sample

Study Population

Fibromyalgia group: Fifty fibromyalgia patients who met the inclusion criteria who applied to the outpatient clinic between December 2020-January 2021 and volunteered to participate in the study.

Control Group:50 participants who will be selected from clinical staff or patients companion who meet the inclusion criteria who agree to participate in the study

Description

Inclusion Criteria (Fibromyalgia group):

  • Patients diagnosed as Fibromyalgia syndrome according to American College of Rheumatology over 1 year
  • Patients' disease activity is stabil at least 3 months Inclusion Criteria (Control group) Patients have no physicologic or severe musculoskeletal and rheumatologic diseases

Exclusion Criteria:

  • Patients with having other modd disorders
  • Patients with severe musculoskeletal diseases
  • Patients with other rheumatologic diseases

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

Cohorts and Interventions

Group / Cohort
Fibromyalgia group
Diagnosed as Fibromyalgia according to American College of Rheumatology Fibromyalgia 2018 classification criteria over 1 year, and disease activity was stabil with the same drug at least 3 months.
Control Group
The participants who have no physicological or severe musculoskeletal, rheumatologic diseases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Covid-19 anxiety
Time Frame: 15 seconds
It is evaluated by the Coronavirus anxiety scale (CAS). It was developed by Lee et al. and Evren et al. were made validity and reliability of this scale in Turkish. It is 5-items scale, and each item scores between 0-4. The total score (ranging from 0 to 20) is calculated by adding up each item score. The higher the score, the greater the anxiety associated with coronavirus-19. Level of Covid-19 anxiety will be compared between fibromyalgia and control groups.
15 seconds
Level of Covid-19 fear
Time Frame: 15 seconds
It is evaluated with The Fear Covid-19 Scale which was developed by Ahorsu et al., and it was adapted into Turkish. It is 7-item scale, each item scores with 5-pont Likert scale. Total score is 35, and the higher score describe higher fear level. Level of Covid-19 fear will be compared between fibromyalgia and control groups.
15 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Covid-19 anxiety and fear levels on daily life the patients with fibromyalgia
Time Frame: 15 seconds

The daily life of fibromyalgia patients will be analyzed with Fibromyalgia Impact questionnaire (FIQ). It has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10. It is divided three domains: function, over impact, symptoms. The summed score for function (range 0 to 90) is divided by 3, the summed score or overall impact (range 0 to 20) is not changed, and the summed score for symptoms (range 0 to 100) is divided by 2. The total score is the sum of the three modified domain scores, and total score ranges from 0 to 100. Higher scores indicate worse daily life.

Investigators will be analyzed the relationship between CAS, the fear Covid-19 Scale, and the FIQ.
15 seconds
The Covid-19 anxiety and fear levels on sleep quality the patients with fibromyalgia
Time Frame: 15 seconds
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The sum of scores for these seven components yields one global score.The total score ranges from 0-21. A total score greater than 5 indicates "poor sleep quality" Investigators will be analyzed the relationship between CAS, the fear Covid-19 Scale, and the PSQI.
15 seconds
The Covid-19 anxiety and fear levels on anxiety-depression the patients with fibromyalgia
Time Frame: 15 seconds
The anxiety and depression level will be evaluated with Hospital anxiety-and depression scale (HADS).The purpose of the scale is not to make a diagnosis. The scale is a self-report scale and consists of 14 questions, 7 of which investigate depression, and 7 of which investigate anxiety of patients.
15 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Investigators

  • Principal Investigator: Damla Cankurtaran, MD, Diskapi Yildirim Beyazit Education and Research Hospital
  • Study Chair: Ece uNLU aKYUZ, Assoc Prof., Diskapi Yildirim Beyazit Education and Research Hospital
  • Study Chair: Nihal Tezel, MD, Diskapi Yildirim Beyazit Education and Research Hospital

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.

General Publications

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 (Actual)

December 1, 2020

Primary Completion (Anticipated)

February 15, 2021

Study Completion (Anticipated)

February 28, 2021

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

December 24, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fibromyalgia-pandemi

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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