Artificial Intelligence, and E-Health Literacy in Fibromyalgia

NCT07020845 | Completed

• 1 other identifier: 2024-GOKAEK-2411_2024.10.16_16
• Study Type: observational
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia Syndrome; Healthy Controls Group - Age and Sex-matched

Keywords

Fibromyalgia Syndrome; Artificial Intelligence Literacy; Electronic Health Literacy; Revised Fibromyalgia Impact Questionnaire; Beck Depression Inventory; Beck Anxiety Inventory

Outcome Measures

Primary Outcomes (2)

• E-Health Literacy

  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

  At baseline"

• Artificial Intelligence Literacy

  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

  At baseline"

Secondary Outcomes (3)

• the Revised Fibromyalgia Impact Questionnaire

  At baseline

• the Beck Depression Inventory

  At baseline

• Beck Anxiety Inventory

  At baseline

Study Arms (2)

the patient group

Patients aged 18 to 50 who attended the Physical Medicine and Rehabilitation outpatient clinic at Bozok University Faculty of Medicine, met the 2016 American College of Rheumatology fibromyalgia diagnostic criteria, demonstrated adequate cognitive function, were literate, and consented to participate were enrolled as the patient group

Other: Observation only

The control group

The control group consisted of healthy volunteers matched to the patient group in terms of age and sex, aged 18-50 years, with intact cognitive function and literacy skills, no reported health issues, and who willingly consented to participate in the study

Other: Observation only

Interventions

Observation only OTHER

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

The control group; the patient group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study included 106 patients diagnosed with Fibromyalgia Syndrome according to the 2016 American College of Rheumatology criteria and 106 age- and sex-matched healthy controls. Participants were aged between 18 and 50 years, literate, with adequate cognitive function, and voluntarily provided informed consent. The patient group was recruited from the Physical Medicine and Rehabilitation outpatient clinic at Yozgat Bozok University Faculty of Medicine. The control group consisted of healthy volunteers without any reported health issues.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulseren Demir Karakilic: lead

Study Sites (1)

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

Yozgat, Yozgat, 66100, Turkey (Türkiye)

Location

Related Publications (7)

• Çelebi, C., et al., Artificial intelligence literacy: An adaptation study. Instructional Technology and Lifelong Learning, 2023

  BACKGROUND

• Wang, B., P.-L.P. Rau, and T. Yuan, Measuring user competence in using artificial intelligence: validity and reliability of artificial intelligence literacy scale. Behaviour & information technology, 2023

  BACKGROUND

• TAMER GENCER, Z., Analysis of validity and reliability of Norman and Skinner's e-Health scale literacy for cultural adaptatio

  BACKGROUND

• Norman CD, Skinner HA. eHealth Literacy: Essential Skills for Consumer Health in a Networked World. J Med Internet Res. 2006 Jun 16;8(2):e9. doi: 10.2196/jmir.8.2.e9.

  PMID: 16867972 BACKGROUND

• Ulusoy, M., N.H. Sahin, and H. Erkmen, Turkish version of the Beck Anxiety Inventory: psychometric properties. Journal of cognitive psychotherapy, 1998

  BACKGROUND

• Hisli, N., Beck depresyon envanterinin universite ogrencileri icin gecerliligi, guvenilirlig

  BACKGROUND

• Sarmer S, Ergin S, Yavuzer G. The validity and reliability of the Turkish version of the Fibromyalgia Impact Questionnaire. Rheumatol Int. 2000 Dec;20(1):9-12. doi: 10.1007/s002960000077.

  PMID: 11149662 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Gülseren Demir Karakılıç, Assistant Professor

  Yozgat Bozok University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Principal Investigator

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 13, 2025
• Study Start: December 16, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon study completion
• Access Criteria: Researchers who provide a reasonable request and have a valid scientific purpose will be granted access to the individual participant data (IPD) and supporting documents, including the study protocol and informed consent form. Requests should be submitted to the corresponding author via email. Data sharing will be subject to approval to ensure participant confidentiality and compliance with ethical standards. Data will be shared in a de-identified format to protect participant privacy

Locations

TU (1)