Clinical trial NCT05410808: Anxiety, Depression, and Quality of Life in Patients With Fibromyalgia During the Coronavirus Disease 2019 Pandemic
Official title: Levels of Anxiety, Depression, and Quality of Life in Patients With Fibromyalgia During the COVID-19 Pandemic: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Coronavirus Disease 2019 Pandemic
Keywords: fibromyalgia
coronavirus disease 2019
pain
anxiety
quality of life
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with fibromyalgia and who are older than 18 years of age and controls that live in the same household as the fibromyalgia patients

Brief summary: Fibromyalgia patients and controls living in the same household will be evaluated for levels of resilience, covid-19 related anxiety, coronavirus disease 2019 related obsession, quality of life and pain and comparisons and correlation analyses will be carried out.

Detailed description: Fibromyalgia is a generalized pain condition that is accompanied by sleep disturbances, anxiety, depression and somatic symptoms. During Coronavirus disease 2019 pandemic, fibromyalgia patients as well as the general population have increased anxiety levels. This study was planned to evaluate fibromyalgia patients' levels of coronavirus disease 2019 related resilience, anxiety, obsession levels about coronavirus disease 2019, quality of life and pain levels and compare them with healthy controls living in the same household.

Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of fibromyalgia according to the American college of rheumatology 2016 classification criteria
* Older than 18 years of age

Exclusion Criteria:

* Illiteracy
* A history of coronavirus disease 2019 infection in the last month
* Change in medication to treat fibromyalgia in the last 3 months
* Living alone (lack of a control subject)
* Severe neurological or psychiatric disorder that might hinder subjects' ability to answer the study questions

Primary outcomes:
measure: Resilience
timeFrame: Day 1
measure: Covid anxiety
timeFrame: Day 1
measure: Obsession with covid-19
timeFrame: Day 1
measure: Quality of life assessment
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bornova
country: Turkey
facility: Ege University School of Medicine
state: Izmir
Study officials:
affiliation: Principal Investigator
name: Ece Cinar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazza MG, De Lorenzo R, Conte C, Poletti S, Vai B, Bollettini I, Melloni EMT, Furlan R, Ciceri F, Rovere-Querini P; COVID-19 BioB Outpatient Clinic Study group; Benedetti F. Anxiety and depression in COVID-19 survivors: Role of inflammatory and clinical predictors. Brain Behav Immun. 2020 Oct;89:594-600. doi: 10.1016/j.bbi.2020.07.037. Epub 2020 Jul 30.
citation: Qiu J, Shen B, Zhao M, Wang Z, Xie B, Xu Y. A nationwide survey of psychological distress among Chinese people in the COVID-19 epidemic: implications and policy recommendations. Gen Psychiatr. 2020 Mar 6;33(2):e100213. doi: 10.1136/gpsych-2020-100213. eCollection 2020.
citation: Cankurtaran D, Tezel N, Ercan B, Yildiz SY, Akyuz EU. The effects of COVID-19 fear and anxiety on symptom severity, sleep quality, and mood in patients with fibromyalgia: a pilot study. Adv Rheumatol. 2021 Jun 30;61(1):41. doi: 10.1186/s42358-021-00200-9.