Clinical trial NCT07020845: Artificial Intelligence, and E-Health Literacy in Fibromyalgia
Official title: An Investigation on Artificial Intelligence Literacy and E-Health Literacy of Patients With Fibromyalgia Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: E-Health Literacy
timeFrame: At baseline"
measure: Artificial Intelligence Literacy
timeFrame: At baseline"
Secondary outcomes:
measure: the Revised Fibromyalgia Impact Questionnaire
timeFrame: At baseline
measure: the Beck Depression Inventory
timeFrame: At baseline
measure: Beck Anxiety Inventory
timeFrame: At baseline
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Yozgat Bozok University
name: Gülseren Demir Karakılıç, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Çelebi, C., et al., Artificial intelligence literacy: An adaptation study. Instructional Technology and Lifelong Learning, 2023
citation: 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
citation: TAMER GENCER, Z., Analysis of validity and reliability of Norman and Skinner's e-Health scale literacy for cultural adaptatio
citation: 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.
citation: Ulusoy, M., N.H. Sahin, and H. Erkmen, Turkish version of the Beck Anxiety Inventory: psychometric properties. Journal of cognitive psychotherapy, 1998
citation: Hisli, N., Beck depresyon envanterinin universite ogrencileri icin gecerliligi, guvenilirlig
citation: 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.