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NCT Number: NCT07020845

Artificial Intelligence, and E-Health Literacy in Fibromyalgia

This cross-sectional observational study aimed to assess electronic health literacy and artificial intelligence literacy among individuals diagnosed with fibromyalgia syndrome, with particular focus on artificial intelligence literacy. Although general health literacy has been investigated in this patient population, digital and artificial intelligence-related competencies have not been sufficiently studied. The research included 106 individuals diagnosed with fibromyalgia syndrome and 106 age- and sex-matched healthy volunteers, recruited between December 2024 and May 2025. All participants completed a series of standardized questionnaires, including the Revised Fibromyalgia Impact Questionnaire, the Beck Depression Inventory, the Beck Anxiety Inventory, the Electronic Health Literacy Scale, and the Artificial Intelligence Literacy Scale. The study explored demographic, clinical, and psychological factors associated with digital and artificial intelligence literacy levels among both patient and control groups.

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Key information

Conditions

Fibromyalgia Syndrome Fibromyalgia Healthy Controls Group - Age and Sex-matched Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Yozgat, 66100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Age between 18 and 50 years

Diagnosis of Fibromyalgia Syndrome according to 2016 American College of Rheumatology criteria (for patient group)

Adequate cognitive function

Literacy

Willingness to participate and provide informed consent

For control group: Healthy individuals matched by age and sex, with no reported health issues

Exclusion criteria

Cognitive impairment preventing questionnaire completion

Illiteracy

Presence of severe comorbidities or neurological/psychiatric disorders that may affect participation

Refusal or inability to provide informed consent

Treatment and study plan

observation only

Other

This is an observational study with no intervention applied to participants. Data were collected through questionnaires and clinical assessments only

Primary outcomes

  1. E-Health Literacy

    Time frame: At baseline"

    An 8-item, 5-point Likert-type scale developed by Norman and Skinner , validated in Turkish by Tamer Gencer. Higher scores indicate higher e- Health Literacy

  2. Artificial Intelligence Literacy

    Time frame: At baseline"

    A 12-item, 7-point Likert-type scale developed by Wang et al . and adapted into Turkish by Çelebi et al . Higher scores indicate greater Artificial Intelligence literacy

Secondary outcomes

  1. the Revised Fibromyalgia Impact Questionnaire

    Time frame: At baseline

    aims to measure patients with fibromyalgia syndrome status, progress and outcomes through 21 questions that inquire about physical functions, work-related situations, depression, anxiety, waking up tired, pain, stiffness, and fatigue The Turkish adaptation of the Revised Fibromyalgia Impact Questionnairewas psychometrically evaluated for validity and reliability by Sarmer et al .

  2. the Beck Depression Inventory

    Time frame: At baseline

    is developed by Beck and colleagues in 1961, is intended to evaluate the typical signs and symptoms associated with depression. This instrument is a self-administered questionnaire comprising 21 items and usually requires around 10 minutes to complete. The Turkish version of the inventory was adapted and validated by Hisli and colleagues

  3. Beck Anxiety Inventory

    Time frame: At baseline

    is developed by Aaron T. Beck, is an internationally validated tool for assessing anxiety levels. It consists of 21 items. The Turkish adaptation and validation of the inventory were performed by Ulusoy and colleagues

Sponsors and collaborators

Lead sponsor

Gulseren Demir Karakilic

Other

Registry information

Official study title

An Investigation on Artificial Intelligence Literacy and E-Health Literacy of Patients With Fibromyalgia Syndrome

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

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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