Orthorexia Nervosa in Fibromyalgia

April 20, 2025 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 84 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. 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

84

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
      • Istanbul, Turkey, 34147
        • Recruiting
        • Beylikdüzü State Hospital
        • Contact:
        • Principal Investigator:
          • Büşra Şirin Ahısha, MD
        • Sub-Investigator:
          • Nurdan Paker, Prof
        • Sub-Investigator:
          • Fatma Nur Kesiktaş, Prof
        • Sub-Investigator:
          • Nazlı Derya Buğdaycı, Doc
        • Sub-Investigator:
          • Yiğit Can Ahısha, MD

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

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
Intervention / Treatment
fibromyalgia group
Other: Fibromyalgia
no intervention
Other Names:
  • No intervention

What is the study measuring?

Primary Outcome Measures

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

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

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)

April 20, 2025

Primary Completion (Estimated)

May 20, 2025

Study Completion (Estimated)

May 20, 2025

Study Registration Dates

First Submitted

April 20, 2025

First Submitted That Met QC Criteria

April 20, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 20, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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