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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05410808
• Other study ID #: 21-1T/52
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: January 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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
• 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

Locations

Country	Name	City	State
Turkey	Ege University School of Medicine	Bornova	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. Erratum In: Gen Psychiatr. 2020 Apr 27;33(2):e100213corr1. — View Citation

Outcome

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