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
|Condition or disease|
|Fibromyalgia Covid-19 Fear Covid-19 Anxiety Daily Life Sleep Quality Anxiety Depression|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
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.
The participants who have no physicological or severe musculoskeletal, rheumatologic diseases.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Damla Cankurtaran, MDfirstname.lastname@example.org|
|Diskapi Education and Research Hospital||Recruiting|
|Ankara, Altındag, Turkey, 06300|
|Contact: Damla Cankurtaran, MD +903125962994 email@example.com|
|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|