FibromyalgiaNCT04686578
The Effects of Covid-19 Pandemic on The Patients With Fibromyalgia
An observational study of Fibromyalgia and Covid-19 Fear, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators planned to analyze the effect of Covid-19 fear and anxiety on the daily life, sleep quality and depression-anxiety levels of fibromyalgia patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Covid-19 Fear, Covid-19 Anxiety
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 28 Feb 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Fibromyalgia group: Fifty fibromyalgia patients who met the inclusion criteria who applied to the outpatient clinic between December 2020-January 2021 and volunteered to participate in the study. Control Group:50 participants who will be selected from clinical staff or patients companion who meet the inclusion criteria who agree to participate in the study
Who may be able to join
- Patients diagnosed as Fibromyalgia syndrome according to American College of Rheumatology over 1 year
- Patients' disease activity is stabil at least 3 months Inclusion Criteria (Control group) Patients have no physicologic or severe musculoskeletal and rheumatologic diseases
Who cannot join
- Patients with having other modd disorders
- Patients with severe musculoskeletal diseases
- Patients with other rheumatologic diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Diskapi Education and Research Hospital
Ankara, Altındag, 06300
Damla Cankurtaran, MD, +903125962994, damlacengizftr@gmail.com
About this study
Official title: Investigation the Effect of Covid-19 Fear, Anxiety on Daily Life, Sleep Quality, and Anxiety-depression of the Patients With Fibromyalgia
The investigators planned to analyze the effect of Covid-19 fear and anxiety on the daily life, sleep quality and depression-anxiety levels of fibromyalgia patients.
Read the detailed description
Fibromyalgia; as a chronic syndrome of unknown cause with widespread body pain, fatigue, sleep disorder, cognitive impairment and anxiety. Many studies have shown a relationship between pain levels and anxiety levels in patients with fibromyalgia. Covid-19 started from Wuhan, China in December 2019 and spread worldwide. The rapid spread of this unexpected pandemic all over the world brought with it many conditions such as anxiety and stress disorders. It has been reported by experts that individuals with a predisposition to conditions such as anxiety and stress disorder in premorbidity require special attention.To evaluate the psychological effects of the Covid-19 pandemic, the Covid-19 anxiety scale was developed from Lee et al. and the Covid-19 fear scale was developed from Ahoursou et al. The investigators planned to analyzed the effect on Covid-19 fear and anxiety level on fibromyalgia patients' daily life with revised Fibromyalgia Impact questionnaire, sleep quality with Pittsburgh Sleep Quality Index, and anxiety-depression level with The Hospital Anxiety and Depression scale. This study was planned as a cross-sectional case control study.
- Conditions
- Fibromyalgia, Covid-19 Fear, Covid-19 Anxiety, Daily Life, Sleep Quality, Anxiety Depression
- Medical subject headings
- Fibromyalgia, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia group | Diagnosed as Fibromyalgia according to American College of Rheumatology Fibromyalgia 2018 classification criteria over 1 year, and disease activity was stabil with the same drug at least 3 months. | |
| Control Group | The participants who have no physicological or severe musculoskeletal, rheumatologic diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Covid-19 anxiety
It is evaluated by the Coronavirus anxiety scale (CAS). It was developed by Lee et al. and Evren et al. were made validity and reliability of this scale in Turkish. It is 5-items scale, and each item scores between 0-4. The total score (ranging from 0 to 20) is calculated by adding up each item score. The higher the score, the greater the anxiety associated with coronavirus-19. Level of Covid-19 anxiety will be compared between fibromyalgia and control groups.
Measured: 15 seconds
Level of Covid-19 fear
It is evaluated with The Fear Covid-19 Scale which was developed by Ahorsu et al., and it was adapted into Turkish. It is 7-item scale, each item scores with 5-pont Likert scale. Total score is 35, and the higher score describe higher fear level. Level of Covid-19 fear will be compared between fibromyalgia and control groups.
Measured: 15 seconds
Secondary outcomes (3)
The Covid-19 anxiety and fear levels on daily life the patients with fibromyalgia
The daily life of fibromyalgia patients will be analyzed with Fibromyalgia Impact questionnaire (FIQ). It has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10. It is divided three domains: function, over impact, symptoms. The summed score for function (range 0 to 90) is divided by 3, the summed score or overall impact (range 0 to 20) is not changed, and the summed score for symptoms (range 0 to 100) is divided by 2. The total score is the sum of the three modified domain scores, and total score ranges from 0 to 100. Higher scores indicate worse daily life.
Investigators will be analyzed the relationship between CAS, the fear Covid-19 Scale, and the FIQ.
Measured: 15 seconds
The Covid-19 anxiety and fear levels on sleep quality the patients with fibromyalgia
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The sum of scores for these seven components yields one global score.The total score ranges from 0-21. A total score greater than 5 indicates "poor sleep quality" Investigators will be analyzed the relationship between CAS, the fear Covid-19 Scale, and the PSQI.
Measured: 15 seconds
The Covid-19 anxiety and fear levels on anxiety-depression the patients with fibromyalgia
The anxiety and depression level will be evaluated with Hospital anxiety-and depression scale (HADS).The purpose of the scale is not to make a diagnosis. The scale is a self-report scale and consists of 14 questions, 7 of which investigate depression, and 7 of which investigate anxiety of patients.
Measured: 15 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Dec 2020
- Primary completion15 Feb 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Damla Cankurtaran, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- Damla Cankurtaran, MD, Principal investigator, Diskapi Yildirim Beyazit Education and Research HospitalEce uNLU aKYUZ, Assoc Prof., Study chair, Diskapi Yildirim Beyazit Education and Research HospitalNihal Tezel, MD, Study chair, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686578
- Sponsor's protocol ID
- Fibromyalgia-pandemi
- Status last verified
- Feb 2021
- First submitted
- 23 Dec 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salameh P, Hajj A, Badro DA, Abou Selwan C, Aoun R, Sacre H. Mental Health Outcomes of the COVID-19 Pandemic and a Collapsing Economy: Perspectives from a Developing Country. Psychiatry Res. 2020 Dec;294:113520. doi: 10.1016/j.psychres.2020.113520. Epub 2020 Oct 22.
PubMed 33142145Mohabbat AB, Mohabbat NML, Wight EC. Fibromyalgia and Chronic Fatigue Syndrome in the Age of COVID-19. Mayo Clin Proc Innov Qual Outcomes. 2020 Dec;4(6):764-766. doi: 10.1016/j.mayocpiqo.2020.08.002. Epub 2020 Nov 13. No abstract available.
PubMed 33204998
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation the Effect of Covid-19 Fear, Anxiety on Daily Life, Sleep Quality, and Anxiety-depression of the Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT04686578
- Acronym / sponsor ID
- Fibromyalgia-pandemi
- Conditions
- Fibromyalgia, Covid-19 Fear, Covid-19 Anxiety, Daily Life, Sleep Quality, Anxiety Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 28 Dec 2020 (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.
The investigators planned to analyze the effect of Covid-19 fear and anxiety on the daily life, sleep quality and depression-anxiety levels of fibromyalgia patients.
Detailed description
Fibromyalgia; as a chronic syndrome of unknown cause with widespread body pain, fatigue, sleep disorder, cognitive impairment and anxiety. Many studies have shown a relationship between pain levels and anxiety levels in patients with fibromyalgia. Covid-19 started from Wuhan, China in December 2019 and spread worldwide. The rapid spread of this unexpected pandemic all over the world brought with it many conditions such as anxiety and stress disorders. It has been reported by experts that individuals with a predisposition to conditions such as anxiety and stress disorder in premorbidity require special attention.To evaluate the psychological effects of the Covid-19 pandemic, the Covid-19 anxiety scale was developed from Lee et al. and the Covid-19 fear scale was developed from Ahoursou et al. The investigators planned to analyzed the effect on Covid-19 fear and anxiety level on fibromyalgia patients' daily life with revised Fibromyalgia Impact questionnaire, sleep quality with Pittsburgh Sleep Quality Index, and anxiety-depression level with The Hospital Anxiety and Depression scale. This study was planned as a cross-sectional case control study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia group | – | –Diagnosed as Fibromyalgia according to American College of Rheumatology Fibromyalgia 2018 classification criteria over 1 year, and disease activity was stabil with the same drug at least 3 months. |
| Control Group | – | –The participants who have no physicological or severe musculoskeletal, rheumatologic diseases. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Fibromyalgia group: Fifty fibromyalgia patients who met the inclusion criteria who applied to the outpatient clinic between December 2020-January 2021 and volunteered to participate in the study. Control Group:50 participants who will be selected from clinical staff or patients companion who meet the inclusion criteria who agree to participate in the study
Key inclusion criteria (2 listed)
- Patients diagnosed as Fibromyalgia syndrome according to American College of Rheumatology over 1 year
- Patients' disease activity is stabil at least 3 months Inclusion Criteria (Control group) Patients have no physicologic or severe musculoskeletal and rheumatologic diseases
Key exclusion criteria (3 listed)
- Patients with having other modd disorders
- Patients with severe musculoskeletal diseases
- Patients with other rheumatologic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of Covid-19 anxiety
Time frame: 15 seconds
It is evaluated by the Coronavirus anxiety scale (CAS). It was developed by Lee et al. and Evren et al. were made validity and reliability of this scale in Turkish. It is 5-items scale, and each item scores between 0-4. The total score (ranging from 0 to 20) is calculated by adding up each item score. The higher the score, the greater the anxiety associated with coronavirus-19. Level of Covid-19 anxiety will be compared between fibromyalgia and control groups.
Level of Covid-19 fear
Time frame: 15 seconds
It is evaluated with The Fear Covid-19 Scale which was developed by Ahorsu et al., and it was adapted into Turkish. It is 7-item scale, each item scores with 5-pont Likert scale. Total score is 35, and the higher score describe higher fear level. Level of Covid-19 fear will be compared between fibromyalgia and control groups.
3 secondary outcomes
The Covid-19 anxiety and fear levels on daily life the patients with fibromyalgia
Time frame: 15 seconds
The Covid-19 anxiety and fear levels on sleep quality the patients with fibromyalgia
Time frame: 15 seconds
The Covid-19 anxiety and fear levels on anxiety-depression the patients with fibromyalgia
Time frame: 15 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Background: PubMed 33142145Salameh P, Hajj A, Badro DA, Abou Selwan C, Aoun R, Sacre H. Mental Health Outcomes of the COVID-19 Pandemic and a Collapsing Economy: Perspectives from a Developing Country. Psychiatry Res. 2020 Dec;294:113520. doi: 10.1016/j.psychres.2020.113520. Epub 2020 Oct 22.
- Background: PubMed 33204998Mohabbat AB, Mohabbat NML, Wight EC. Fibromyalgia and Chronic Fatigue Syndrome in the Age of COVID-19. Mayo Clin Proc Innov Qual Outcomes. 2020 Dec;4(6):764-766. doi: 10.1016/j.mayocpiqo.2020.08.002. Epub 2020 Nov 13. No abstract available.
- 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.
Damla Cankurtaran, MD principal investigator
Diskapi Yildirim Beyazit Education and Research Hospital
Ece uNLU aKYUZ, Assoc Prof. study chair
Diskapi Yildirim Beyazit Education and Research Hospital
Nihal Tezel, MD study chair
Diskapi Yildirim Beyazit Education and Research Hospital
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 Covid-19 Fear, run by Diskapi Yildirim Beyazit Education and Research Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 3 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damla Cankurtaran, MD (+905054558101, damlacengizftr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Covid-19 anxiety (time frame: 15 seconds). The study lists 2 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 NCT04686578, which also lists 2 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 3 Feb 2021.