FibromyalgiaNCT06947200
Orthorexia Nervosa in Fibromyalgia
An observational study of Fibromyalgia, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
This clinical cross-sectional study will include 86 female patients aged between 18 and 65 years who have been diagnosed with fibromyalgia syndrome according to the 2010 American College of Rheumatology diagnostic criteria and 86 female patients for control group. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Fibromyalgia
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2026to 20 May 2026
- 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
- Women only
- Adult, Older adult
Study population: Patients with fibromyalgia syndrome
Who may be able to join
- Female patients aged 18-65 years.
- Diagnosis of fibromyalgia syndrome according to the 2010 American College of Rheumatology diagnostic criteria.
- Willingness to participate and provision of written informed consent.
Who cannot join
- Refusal to participate.
- Presence of diagnosed psychiatric disorders.
- Presence of cognitive impairment.
- Use of medications that may affect mood.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Dr Sadi Konuk Training and Research Hospital
Istanbul, 34147
About this study
Official title: Is There a Link Between Orthorexia Nervosa, Body Image and Psychological State in Women With Fibromyalgia Syndrome?
This clinical cross-sectional study will include 86 female patients aged between 18 and 65 years who have been diagnosed with fibromyalgia syndrome according to the 2010 American College of Rheumatology diagnostic criteria and 86 female patients for control group. Sociodemographic data will be recorded at the beginning of the study. Pain severity will be assessed using the Visual Analog Scale (VAS). Orthorexia nervosa-related symptoms will be evaluated with the ORTO-11 scale. Body image will be assessed with the Body Appreciation Scale 2, mood will be evaluated using the Hospital Anxiety and Depression Scale (HADS), and fibromyalgia-related impact will be assessed with the Fibromyalgia Impact Questionnaire (FIQ).
- Conditions
- Fibromyalgia
- Being tested
- Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibromyalgiaOther
Also called No intervention
no intervention
| Study group | Role | What they receive |
|---|---|---|
| fibromyalgia group | Not described Receives: Other: Fibromyalgia | |
| Control group | Not described Receives: Other: Fibromyalgia |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORTO-11 Scale
The ORTO-11 assesses orthorexic tendencies, which refer to an unhealthy obsession with healthy eating. It consists of 11 items rated on a 4-point Likert scale. Total scores range from 11 to 44, with lower scores indicating a higher risk of orthorexia nervosa.
Measured: Baseline
Secondary outcomes (4)
Hospital Anxiety Scale (HADS-A):
The HADS-A subscale evaluates symptoms of anxiety. It consists of 7 items, each scored between 0 and 3. The total score ranges from 0 to 21, with higher scores indicating higher levels of anxiety.
Measured: Baseline
Hospital Depression Scale (HADS-D):
The HADS-D subscale evaluates symptoms of depression. It consists of 7 items, each scored between 0 and 3. The total score ranges from 0 to 21, with higher scores indicating higher levels of depression.
Measured: Baseline
Body Appreciation Scale-2 (BAS-2)
The BAS-2 assesses positive body image and appreciation of one's body. It consists of 10 items rated on a 5-point Likert scale (1 = Never, 5 = Always). Total scores range from 10 to 50, with higher scores indicating greater body appreciation.
Measured: Baseline
Fibromyalgia Impact Questionnaire (FIQ)
The FIQ is a self-reported instrument designed to assess the health status and functional impact of fibromyalgia. It consists of 10 items evaluating physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well-being. The total score ranges from 0 to 100, with higher scores indicating greater functional impairment and symptom severity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start20 Apr 2026
- Primary completion20 May 2026
- Study completion20 May 2026
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
- 86 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947200
- Sponsor's protocol ID
- BeylikduzuStateH18
- Status last verified
- Aug 2026
- First submitted
- 20 Apr 2025
- Last updated
- 19 Aug 2026
- 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Link Between Orthorexia Nervosa, Body Image and Psychological State in Women With Fibromyalgia Syndrome?
- ClinicalTrials.gov ID
- NCT06947200
- Acronym / sponsor ID
- BeylikduzuStateH18
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 27 Apr 2025 (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.
This clinical cross-sectional study will include 86 female patients aged between 18 and 65 years who have been diagnosed with fibromyalgia syndrome according to the 2010 American College of Rheumatology diagnostic criteria and 86 female patients for control group. Sociodemographic data will be recorded at the beginning of the study. Pain severity will be assessed using the Visual Analog Scale (VAS). Orthorexia nervosa-related symptoms will be evaluated with the ORTO-11 scale. Body image will be assessed with the Body Appreciation Scale 2, mood will be evaluated using the Hospital Anxiety and Depression Scale (HADS), and fibromyalgia-related impact will be assessed with the Fibromyalgia Impact Questionnaire (FIQ).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fibromyalgia group | – | Other: Fibromyalgia |
| Control group | – | Other: Fibromyalgia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with fibromyalgia syndrome
Key inclusion criteria (3 listed)
- Female patients aged 18-65 years.
- Diagnosis of fibromyalgia syndrome according to the 2010 American College of Rheumatology diagnostic criteria.
- Willingness to participate and provision of written informed consent.
Key exclusion criteria (4 listed)
- Refusal to participate.
- Presence of diagnosed psychiatric disorders.
- Presence of cognitive impairment.
- Use of medications that may affect mood.
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 |
|---|---|---|
| FibromyalgiaAlso: No interventionno intervention | Other | Control group, fibromyalgia group |
Primary outcome
ORTO-11 Scale
Time frame: Baseline
The ORTO-11 assesses orthorexic tendencies, which refer to an unhealthy obsession with healthy eating. It consists of 11 items rated on a 4-point Likert scale. Total scores range from 11 to 44, with lower scores indicating a higher risk of orthorexia nervosa.
4 secondary outcomes
Hospital Anxiety Scale (HADS-A):
Time frame: Baseline
Hospital Depression Scale (HADS-D):
Time frame: Baseline
Body Appreciation Scale-2 (BAS-2)
Time frame: Baseline
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Baseline
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 19 Aug 2026.
- 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 Beylikduzu State 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 4 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 19 Aug 2026. 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?
ORTO-11 Scale (time frame: Baseline). 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 19 Aug 2026.