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

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ClinicalTrials.gov Identifier: NCT04686578
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Damla Cankurtaran, Diskapi Yildirim Beyazit Education and Research Hospital

Brief Summary:
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.

Condition or disease
Fibromyalgia Covid-19 Fear Covid-19 Anxiety Daily Life Sleep Quality Anxiety Depression

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Investigation the Effect of Covid-19 Fear, Anxiety on Daily Life, Sleep Quality, and Anxiety-depression of the Patients With Fibromyalgia
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Fibromyalgia

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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686578


Contacts
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Contact: Damla Cankurtaran, MD +905054558101 damlacengizftr@gmail.com

Locations
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Turkey
Diskapi Education and Research Hospital Recruiting
Ankara, Altındag, Turkey, 06300
Contact: Damla Cankurtaran, MD    +903125962994    damlacengizftr@gmail.com   
Sponsors and Collaborators
Diskapi Yildirim Beyazit Education and Research Hospital
Investigators
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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:
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Responsible Party: Damla Cankurtaran, Medical doctor, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier: NCT04686578    
Other Study ID Numbers: Fibromyalgia-pandemi
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Depression
Anxiety Disorders
Behavioral Symptoms
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases