Orthorexia Nervosa in Fibromyalgia

August 15, 2026 updated by: Busra Sirin, Beylikduzu State Hospital

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34147
        • Bakırköy Dr Sadi Konuk Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients with fibromyalgia syndrome

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Refusal to participate.
  • Presence of diagnosed psychiatric disorders.
  • Presence of cognitive impairment.
  • Use of medications that may affect mood.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control group
Other: Fibromyalgia
no intervention
Other Names:
  • No intervention
fibromyalgia group
Other: Fibromyalgia
no intervention
Other Names:
  • No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Appreciation Scale-2 (BAS-2)
Time Frame: Baseline
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.
Baseline
Hospital Anxiety Scale (HADS-A):
Time Frame: Baseline
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.
Baseline
Hospital Depression Scale (HADS-D):
Time Frame: Baseline
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.
Baseline
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beylikduzu State Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BeylikduzuStateH18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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