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

Completed

• Conditions: Fibromyalgia; Coronavirus Disease 2019 Pandemic
• Interventions: Other: Questionnaires and physical examination; Other: Questionnaire

• Registration Number: NCT05410808
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-06-05
• Study First Submitted QC: 2022-06-05
• Study First Posted: 2022-06-08
• Primary Completion: 2022-06-15
• Study Completion: 2022-07-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fibromyalgia patients	Questionnaires and physical examination	Patients diagnosed as having fibromyalgia according to the American College of Rheumatology 2016 classification criteria
Healthy controls	Questionnaire	Subjects not having fibromyalgia and who live in the same household as the fibromyalgia patients

Primary Outcome Measures

Name	Time	Method
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
Quality of life assessment	Day 1	Measured by Health Survey Questionnaire Short Form 36
Obsession with covid-19	Day 1	Obsession with covid-19, measured by obsession with covid scale

Trial Locations

Locations (1)

Ege University School of Medicine; 🇹🇷 Bornova, Izmir, Turkey