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

January 16, 2023 updated by: Ece Cinar, Ege University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Izmir
      • Bornova, Izmir, Turkey, 35100
        • Ege University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: Ece Cinar, MD, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

June 5, 2022

First Submitted That Met QC Criteria

June 5, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-1T/52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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