NCT06947200

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

April 20, 2025

Last Update Submit

April 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (4)

  • Hospital Anxiety Scale (HADS-A):

    Baseline

  • Hospital Depression Scale (HADS-D):

    Baseline

  • Body Appreciation Scale-2 (BAS-2)

    Baseline

  • Fibromyalgia Impact Questionnaire (FIQ)

    Baseline

Study Arms (1)

fibromyalgia group

Other: Fibromyalgia

Interventions

no intervention

Also known as: No intervention
fibromyalgia group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with fibromyalgia syndrome

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 20, 2025

First Posted

April 27, 2025

Study Start

April 20, 2025

Primary Completion

May 20, 2025

Study Completion

May 20, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations