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OpenTrials
Completed

NCT Number: NCT06947200

Orthorexia Nervosa in Fibromyalgia

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).

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Bakırköy Dr Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fibromyalgia

Other

no intervention

Other names: No intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Beylikduzu State Hospital

Other

Registry information

Official study title

Is There a Link Between Orthorexia Nervosa, Body Image and Psychological State in Women With Fibromyalgia Syndrome?

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2025
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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