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

NCT ID: NCT05410808

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-07-15

Brief Summary

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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

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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.

Conditions

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Fibromyalgia Coronavirus Disease 2019 Pandemic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Fibromyalgia patients

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

Questionnaires and physical examination

Intervention Type OTHER

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

Questionnaire

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Ece Cinar

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ece Cinar, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

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Ege University School of Medicine

Bornova, İzmir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 32738287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32215365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34193303 (View on PubMed)

Other Identifiers

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21-1T/52

Identifier Type: -

Identifier Source: org_study_id

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