Clinical trial NCT04686578: The Effects of Covid-19 Pandemic on The Patients With Fibromyalgia
Official title: Investigation the Effect of Covid-19 Fear, Anxiety on Daily Life, Sleep Quality, and Anxiety-depression of the Patients With Fibromyalgia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibromyalgia
Covid-19 Fear
Covid-19 Anxiety
Daily Life
Sleep Quality
Anxiety Depression
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-12-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Level of Covid-19 anxiety
timeFrame: 15 seconds
measure: Level of Covid-19 fear
timeFrame: 15 seconds
Secondary outcomes:
measure: The Covid-19 anxiety and fear levels on daily life the patients with fibromyalgia
timeFrame: 15 seconds
measure: The Covid-19 anxiety and fear levels on sleep quality the patients with fibromyalgia
timeFrame: 15 seconds
measure: The Covid-19 anxiety and fear levels on anxiety-depression the patients with fibromyalgia
timeFrame: 15 seconds
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Education and Research Hospital
state: Altındag
Study officials:
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: Damla Cankurtaran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: Ece uNLU aKYUZ, Assoc Prof.
role: STUDY_CHAIR
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: Nihal Tezel, MD
role: STUDY_CHAIR
References:
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.
citation: 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. No abstract available.