FibromyalgiaNCT06357793
Evaluation of Work Productivity and Activities of the Fibromyalgia Patients' Relatives
An observational study of Fibromyalgia and Work Productivity, run by Başakşehir Çam & Sakura City Hospital.
Trial summary
Patients suffering from fibromyalgia (FM) are challenged by symptoms such as chronic pain, fatigue, sleep disturbance and emotional distress. Patients diagnosed with fibromyalgia can also negatively affect the relatives they live with due to their existing complaints. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Work Productivity, Quality of Life
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 15 Dec 2024
- How long will I take part?
- 1 Day
- 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: The revised 2016 American College of Rheumatology (ACR) FM diagnostic criteria were used to diagnose FM. Our study group participants have to live with FM patients. Also they have to work in a full or part-time job.
Who may be able to join
- Study Group:
- Must live together with a patient diagnosed with FM 18-65 years old Must work in a full-time/part-time job
- Control Group:
- Must live with a healthy relative 18-65 years old Must work in a full-time/part-time job
Who cannot join
- Must live alone Not having a full-time/part-time job
Trial locations and contacts
No sites are listed yet.
OMER BUCAK, MD contact
About this study
Official title: Evaluation of Work Productivity and Activities of the Relative Living With a Patient With Fibromyalgia Syndrome
Patients suffering from fibromyalgia (FM) are challenged by symptoms such as chronic pain, fatigue, sleep disturbance and emotional distress. Patients diagnosed with fibromyalgia can also negatively affect the relatives they live with due to their existing complaints. It is possible that their relatives accompanying them may lose their workforce due to untreated pain complaints and frequent hospital admissions. The main purpose of our study is to examine whether there is any impact on the working life of the people they live with and whether there is a decrease in their work productivity.
Read the detailed description
This cross-sectional study will evaluate FM patients and their relatives, who are in paid full- or part time employment at the time of the assessment. The study protocol doesn't require any medical intervention. Fibromyalgia severity will be assessed with the fibromyalgia impact questionnaire (FIQ). Evaluation of patient relatives' work productivity and activities will be made with the Work Productivity and Activity Impairment questionnaire: General Health (WPAI:GH). Analyzes will be completed with a group of healthy controls in the study.
- Conditions
- Fibromyalgia, Work Productivity, Quality of Life, Pain, Chronic
- Keywords
- fibromyalgia, work productivity and activity impairment, quality of life
- Medical subject headings
- Fibromyalgia, Chronic Pain
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 | The revised 2016 American College of Rheumatology (ACR) FM diagnostic criteria going to be use to diagnose FM participants group. Their relatives will fill out the WPAI:GH Questionnaire and World Health Organization Quality of Life (WHOQOL). | |
| control | Healthy participants' relatives will fill out the WPAI:GH Questionnaire and World Health Organization Quality of Life (WHOQOL). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Productivity and Activity of Fibromyalgia Patients' Relatives
Work Productivity and Activity Impairment questionnaire
Measured: 1 day
Secondary outcomes (1)
Quality of life Fibromyalgia Patients' Relatives
World Health Organization Quality of Life questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
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.
- 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
- 122 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357793
- Sponsor's protocol ID
- camsakuraftr
- Status last verified
- May 2024
- First submitted
- 5 Apr 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Salaffi F, Di Carlo M, Farah S, Mariani C, Fulginei S, Martino GP, Sarzi-Puttini P. A cross-sectional research on female workers examining the loss of productivity caused by mild, moderate and severe fibromyalgia. Clin Exp Rheumatol. 2022 Jun;40(6):1151-1158. doi: 10.55563/clinexprheumatol/hut4ft. Epub 2022 Jun 8.
PubMed 35699070Neumann L, Buskila D. Quality of life and physical functioning of relatives of fibromyalgia patients. Semin Arthritis Rheum. 1997 Jun;26(6):834-9. doi: 10.1016/s0049-0172(97)80027-3.
PubMed 9213382Tutoglu A, Boyaci A, Koca I, Celen E, Korkmaz N. Quality of life, depression, and sexual dysfunction in spouses of female patients with fibromyalgia. Rheumatol Int. 2014 Aug;34(8):1079-84. doi: 10.1007/s00296-014-2944-z. Epub 2014 Jan 9.
PubMed 24402006
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Work Productivity and Activities of the Relative Living With a Patient With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT06357793
- Acronym / sponsor ID
- camsakuraftr
- Conditions
- Fibromyalgia, Work Productivity, Quality of Life, Pain, Chronic
- Keywords
- fibromyalgia, work productivity and activity impairment, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 10 Apr 2024 (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.
Patients suffering from fibromyalgia (FM) are challenged by symptoms such as chronic pain, fatigue, sleep disturbance and emotional distress. Patients diagnosed with fibromyalgia can also negatively affect the relatives they live with due to their existing complaints. It is possible that their relatives accompanying them may lose their workforce due to untreated pain complaints and frequent hospital admissions. The main purpose of our study is to examine whether there is any impact on the working life of the people they live with and whether there is a decrease in their work productivity.
Detailed description
This cross-sectional study will evaluate FM patients and their relatives, who are in paid full- or part time employment at the time of the assessment. The study protocol doesn't require any medical intervention. Fibromyalgia severity will be assessed with the fibromyalgia impact questionnaire (FIQ). Evaluation of patient relatives' work productivity and activities will be made with the Work Productivity and Activity Impairment questionnaire: General Health (WPAI:GH). Analyzes will be completed with a group of healthy controls in the study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fibromyalgia | – | –The revised 2016 American College of Rheumatology (ACR) FM diagnostic criteria going to be use to diagnose FM participants group. Their relatives will fill out the WPAI:GH Questionnaire and World Health Organization Quality of Life (WHOQOL). |
| control | – | –Healthy participants' relatives will fill out the WPAI:GH Questionnaire and World Health Organization Quality of Life (WHOQOL). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The revised 2016 American College of Rheumatology (ACR) FM diagnostic criteria were used to diagnose FM. Our study group participants have to live with FM patients. Also they have to work in a full or part-time job.
Key inclusion criteria (4 listed)
- Must live together with a patient diagnosed with FM 18-65 years old Must work in a full-time/part-time job
- Must live with a healthy relative 18-65 years old Must work in a full-time/part-time job
Key exclusion criteria (1 listed)
- Must live alone Not having a full-time/part-time job
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
Work Productivity and Activity of Fibromyalgia Patients' Relatives
Time frame: 1 day
Work Productivity and Activity Impairment questionnaire
1 secondary outcome
Quality of life Fibromyalgia Patients' Relatives
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Background: PubMed 35699070Salaffi F, Di Carlo M, Farah S, Mariani C, Fulginei S, Martino GP, Sarzi-Puttini P. A cross-sectional research on female workers examining the loss of productivity caused by mild, moderate and severe fibromyalgia. Clin Exp Rheumatol. 2022 Jun;40(6):1151-1158. doi: 10.55563/clinexprheumatol/hut4ft. Epub 2022 Jun 8.
- Background: PubMed 9213382Neumann L, Buskila D. Quality of life and physical functioning of relatives of fibromyalgia patients. Semin Arthritis Rheum. 1997 Jun;26(6):834-9. doi: 10.1016/s0049-0172(97)80027-3.
- Background: PubMed 24402006Tutoglu A, Boyaci A, Koca I, Celen E, Korkmaz N. Quality of life, depression, and sexual dysfunction in spouses of female patients with fibromyalgia. Rheumatol Int. 2014 Aug;34(8):1079-84. doi: 10.1007/s00296-014-2944-z. Epub 2014 Jan 9.
- Individual participant dataSharing planned: Undecided
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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.
OMER BUCAK, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Work Productivity, run by Başakşehir Çam & Sakura City Hospital.
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 4 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: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 DEMET FERAHMAN, MD (+905364702930, demetferahman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work Productivity and Activity of Fibromyalgia Patients' Relatives (time frame: 1 day). 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 NCT06357793, 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 30 May 2024.