FibromyalgiaNCT05410808
Anxiety, Depression, and Quality of Life in Patients With Fibromyalgia During the Coronavirus Disease 2019 Pandemic
An observational study of Fibromyalgia and Coronavirus Disease 2019 Pandemic, run by Ege University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Coronavirus Disease 2019 Pandemic
- What is being tested?
- Questionnaires and physical examination and Questionnaire
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 15 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Having a diagnosis of fibromyalgia according to the American college of rheumatology 2016 classification criteria
- Older than 18 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Medicine
Bornova, İzmir, 35100
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia, Coronavirus Disease 2019 Pandemic
- Being tested
- Questionnaires and physical examination, Questionnaire
- Keywords
- fibromyalgia, coronavirus disease 2019, pain, anxiety, quality of life
- Medical subject headings
- Fibromyalgia, COVID-19, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and physical examinationOther
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
QuestionnaireOther
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
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia patients | Patients diagnosed as having fibromyalgia according to the American College of Rheumatology 2016 classification criteria Receives: Other: Questionnaires and physical examination | |
| Healthy controls | Subjects not having fibromyalgia and who live in the same household as the fibromyalgia patients Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience
Immunity against traumatic life events, measured by resilience scale for adults
Measured: Day 1
Covid anxiety
Covid related anxiety levels, measured by covid-19 anxiety scale
Measured: Day 1
Obsession with covid-19
Obsession with covid-19, measured by obsession with covid scale
Measured: Day 1
Quality of life assessment
Measured by Health Survey Questionnaire Short Form 36
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Dec 2021
- Primary completion15 Jun 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece Cinar, Ege University
- Investigators
- Ece Cinar, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410808
- Sponsor's protocol ID
- 21-1T/52
- Status last verified
- Jan 2023
- First submitted
- 5 Jun 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32738287Qiu 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.
PubMed 32215365Cankurtaran 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.
PubMed 34193303
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levels of Anxiety, Depression, and Quality of Life in Patients With Fibromyalgia During the COVID-19 Pandemic: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05410808
- Acronym / sponsor ID
- 21-1T/52
- Conditions
- Fibromyalgia, Coronavirus Disease 2019 Pandemic
- Keywords
- fibromyalgia, coronavirus disease 2019, pain, anxiety, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia patients | – | Other: Questionnaires and physical examinationPatients diagnosed as having fibromyalgia according to the American College of Rheumatology 2016 classification criteria |
| Healthy controls | – | Other: QuestionnaireSubjects not having fibromyalgia and who live in the same household as the fibromyalgia patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Having a diagnosis of fibromyalgia according to the American college of rheumatology 2016 classification criteria
- Older than 18 years of age
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires and physical examinationPatients 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 | Other | Fibromyalgia patients |
| QuestionnaireDemographic 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 | Other | Healthy controls |
Primary outcome
Resilience
Time frame: Day 1
Immunity against traumatic life events, measured by resilience scale for adults
Covid anxiety
Time frame: Day 1
Covid related anxiety levels, measured by covid-19 anxiety scale
Obsession with covid-19
Time frame: Day 1
Obsession with covid-19, measured by obsession with covid scale
Quality of life assessment
Time frame: Day 1
Measured by Health Survey Questionnaire Short Form 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Background: PubMed 32738287Mazza 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.
- Background: PubMed 32215365Qiu 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.
- Background: PubMed 34193303Cankurtaran 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ece Cinar, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Coronavirus Disease 2019 Pandemic, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410808, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.