FibromyalgiaNCT03966820
Subjective Ageing in Fibromyalgia
An observational study of Fibromyalgia, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Subjective age or felt age is the term used for how the person feels; one can feel same, younger or older than their actual age. Feeling younger or feeling older may be associated with depression, anxiety, fatigue, sleep, quality of life or cognitive function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- How many people
- 262 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 27 Jan 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 262 patients diagnosed with fibromyalgia will be included in the study
Who may be able to join
- Fibromyalgia diagnosis using 2016 revised American College of Rheumatology
- aged >18 years old
- Widespread pain more than 3 months
Who cannot join
- Any disease that can cause depression, anxiety, fatigue, poor sleep quality or poor cognitive function except from fibromyalgia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subjective Ageing in Fibromyalgia: Why Fibromyalgia Patients Feel Old?
Subjective age or felt age is the term used for how the person feels; one can feel same, younger or older than their actual age. Feeling younger or feeling older may be associated with depression, anxiety, fatigue, sleep, quality of life or cognitive function.
Read the detailed description
In this cross-sectional study, the investigators hypothesized that fibromyalgia patients mostly feel older than their actual age and this felt age may be associated with depression, anxiety, fatigue, sleep, quality of life or cognition. After power analysis, study sample calculated as 262 patients, the present study will use 2016 revised American College of Rheumatology criteria to diagnose fibromyalgia.
- Conditions
- Fibromyalgia
- Keywords
- Anxiety, Cognitive ageing, Depression, Fatigue, Fibromyalgia, Quality of life, Sleep
- Medical subject headings
- Fibromyalgia, Anxiety Disorders, Depression, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective age
The study will ask the patient: " how old do you feel?". Subjective age will calculate as Subjective age extracted from actual age. If the result is positive, the patient feel younger, if visa versa the patient feels older
Measured: Four months
Depression
The status of depression will calculate using Beck Depression Inventory. This inventory is a self scored, 21 item questionnaire. Higher scores indicate higher depression levels of the patient.
Measured: Four months
Anxiety
The status of anxiety will calculate using Beck Anxiety Inventory. This inventory is a self scored, 21 item questionnaire. Higher scores indicate higher anxiety levels of the patient. The total score is calculated by finding the sum of the 21 items. Each question scored 0 to 3 points. Score of 0-21 = low anxiety,score of 22-35 = moderate anxiety, score of 36 and above = potentially concerning levels of anxiety
Measured: Four months
Sleep
The status of sleep quality of the patients will calculate using Pittsburgh Sleep Quality Index. The index is a self- scored 24 item questionnaire and 7 subgroups. Higher scores show bad sleep quality and lower scores indicate good sleep quailty.
Measured: Four months
Fatigue
The fatigue levels of the patients will be determined using The Fatigue Severity Scale. This scale self-reported 9 item questionnaire, each question scored between 0-7, total score divided to nine and if the result <2.8, no fatigue and if > 6.1, chronic fatigue syndrome diagnosis can be made. Higher score shows higher probability of chronic fatigue syndrome.
Measured: Four months
Cognitive Function
The cognition status of the patients will be determined using Mini-mental State Examination. This test includes five subscales, scoreing 0 - 30 points. Lower scores show poorer cognitive function
Measured: Four months
Life Quailty
The quality of life of the patients will be determined using Short-form 36. The self-reported questionnaire includes 11 subscales. Higher scores show poorer quality of life.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Jun 2019
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Akif GÜLER, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966820
- Sponsor's protocol ID
- GaziosmanpasaTREH3
- Status last verified
- Jan 2020
- First submitted
- 22 May 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective Ageing in Fibromyalgia: Why Fibromyalgia Patients Feel Old?
- ClinicalTrials.gov ID
- NCT03966820
- Acronym / sponsor ID
- GaziosmanpasaTREH3
- Conditions
- Fibromyalgia
- Keywords
- Anxiety, Cognitive ageing, Depression, Fatigue, Fibromyalgia, Quality of life, Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 29 May 2019 (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.
Subjective age or felt age is the term used for how the person feels; one can feel same, younger or older than their actual age. Feeling younger or feeling older may be associated with depression, anxiety, fatigue, sleep, quality of life or cognitive function.
Detailed description
In this cross-sectional study, the investigators hypothesized that fibromyalgia patients mostly feel older than their actual age and this felt age may be associated with depression, anxiety, fatigue, sleep, quality of life or cognition. After power analysis, study sample calculated as 262 patients, the present study will use 2016 revised American College of Rheumatology criteria to diagnose fibromyalgia.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 262 patients diagnosed with fibromyalgia will be included in the study
Key inclusion criteria (3 listed)
- Fibromyalgia diagnosis using 2016 revised American College of Rheumatology
- aged >18 years old
- Widespread pain more than 3 months
Key exclusion criteria (1 listed)
- Any disease that can cause depression, anxiety, fatigue, poor sleep quality or poor cognitive function except from fibromyalgia.
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
Subjective age
Time frame: Four months
The study will ask the patient: " how old do you feel?". Subjective age will calculate as Subjective age extracted from actual age. If the result is positive, the patient feel younger, if visa versa the patient feels older
Depression
Time frame: Four months
The status of depression will calculate using Beck Depression Inventory. This inventory is a self scored, 21 item questionnaire. Higher scores indicate higher depression levels of the patient.
Anxiety
Time frame: Four months
The status of anxiety will calculate using Beck Anxiety Inventory. This inventory is a self scored, 21 item questionnaire. Higher scores indicate higher anxiety levels of the patient. The total score is calculated by finding the sum of the 21 items. Each question scored 0 to 3 points. Score of 0-21 = low anxiety,score of 22-35 = moderate anxiety, score of 36 and above = potentially concerning levels of anxiety
Sleep
Time frame: Four months
The status of sleep quality of the patients will calculate using Pittsburgh Sleep Quality Index. The index is a self- scored 24 item questionnaire and 7 subgroups. Higher scores show bad sleep quality and lower scores indicate good sleep quailty.
Fatigue
Time frame: Four months
The fatigue levels of the patients will be determined using The Fatigue Severity Scale. This scale self-reported 9 item questionnaire, each question scored between 0-7, total score divided to nine and if the result <2.8, no fatigue and if > 6.1, chronic fatigue syndrome diagnosis can be made. Higher score shows higher probability of chronic fatigue syndrome.
Cognitive Function
Time frame: Four months
The cognition status of the patients will be determined using Mini-mental State Examination. This test includes five subscales, scoreing 0 - 30 points. Lower scores show poorer cognitive function
Life Quailty
Time frame: Four months
The quality of life of the patients will be determined using Short-form 36. The self-reported questionnaire includes 11 subscales. Higher scores show poorer quality of life.
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 28 Jan 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Gaziosmanpasa Research and Education 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 3 inclusion and 1 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 28 Jan 2020. 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?
Subjective age (time frame: Four months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2020.