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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04686578
• Other study ID #: Fibromyalgia-pandemi
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: February 2021
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: Damla Cankurtaran, MD
• Phone: +905054558101
• Email: damlacengizftr[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Depression
• Anxiety Disorders
• Covid-19 Anxiety
• Covid-19 Fear
• Daily Life
• Depression
• Fibromyalgia
• Myofascial Pain Syndromes
• Sleep Quality

Locations

Country	Name	City	State
Turkey	Diskapi Education and Research Hospital	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Mohabbat AB, Mohabbat NML, Wight EC. Fibromyalgia and Chronic Fatigue Syndrome in the Age of COVID-19. Mayo Clin Proc Innov Qual Outcomes. 2020 Dec;4(6):764-766. doi: 10.1016/j.mayocpiqo.2020.08.002. Epub 2020 Nov 13. Review. — View Citation

Salameh P, Hajj A, Badro DA, Abou Selwan C, Aoun R, Sacre H. Mental Health Outcomes of the COVID-19 Pandemic and a Collapsing Economy: Perspectives from a Developing Country. Psychiatry Res. 2020 Dec;294:113520. doi: 10.1016/j.psychres.2020.113520. Epub 2020 Oct 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Covid-19 anxiety	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
Primary	Level of Covid-19 fear	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	The Covid-19 anxiety and fear levels on daily life the patients with fibromyalgia	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
Secondary	The Covid-19 anxiety and fear levels on sleep quality the patients with fibromyalgia	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
Secondary	The Covid-19 anxiety and fear levels on anxiety-depression the patients with fibromyalgia	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