Anxiety, Depression, and Quality of Life in Patients With Fibromyalgia During the Coronavirus Disease 2019 Pandemic

Sponsor

Ege University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05410808

Collaborator

(none)

Enrollment

Location

7.4

Anticipated Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Coronavirus Disease 2019 Pandemic	Other: Questionnaires and physical examination Other: Questionnaire

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Levels of Anxiety, Depression, and Quality of Life in Patients With Fibromyalgia During the COVID-19 Pandemic: A Cross-sectional Study

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Jun 15, 2022

Anticipated Study Completion Date :

Jul 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Fibromyalgia patients Patients diagnosed as having fibromyalgia according to the American College of Rheumatology 2016 classification criteria	Other: Questionnaires and physical examination Patients will be examined and demographic data, disease characteristics will be recorded. Health Survey Questionnaire Short Form 36 , coronavirus disease 2019 anxiety scale ,Obsession with coronavirus disease 2019 scale, and Resilience scale for adults will be answered
Healthy controls Subjects not having fibromyalgia and who live in the same household as the fibromyalgia patients	Other: Questionnaire Demographic data will be recorded. Health Survey Questionnaire Short Form 36 , coronavirus disease 2019 anxiety scale ,Obsession with coronavirus disease 2019 scale, and Resilience scale for adults will be answered

Arm

Intervention/Treatment

Fibromyalgia patients

Patients diagnosed as having fibromyalgia according to the American College of Rheumatology 2016 classification criteria

Other: Questionnaires and physical examination

Patients will be examined and demographic data, disease characteristics will be recorded. Health Survey Questionnaire Short Form 36 , coronavirus disease 2019 anxiety scale ,Obsession with coronavirus disease 2019 scale, and Resilience scale for adults will be answered

Healthy controls

Subjects not having fibromyalgia and who live in the same household as the fibromyalgia patients

Other: Questionnaire

Demographic data will be recorded. Health Survey Questionnaire Short Form 36 , coronavirus disease 2019 anxiety scale ,Obsession with coronavirus disease 2019 scale, and Resilience scale for adults will be answered

Outcome Measures

Primary Outcome Measures

Resilience [Day 1]
Immunity against traumatic life events, measured by resilience scale for adults
Covid anxiety [Day 1]
Covid related anxiety levels, measured by covid-19 anxiety scale
Obsession with covid-19 [Day 1]
Obsession with covid-19, measured by obsession with covid scale
Quality of life assessment [Day 1]
Measured by Health Survey Questionnaire Short Form 36

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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