Fibromyalgia SyndromeNCT07020845

Artificial Intelligence, and E-Health Literacy in Fibromyalgia

An observational study of Fibromyalgia Syndrome and Healthy Controls Group - Age and Sex-matched, run by Gulseren Demir Karakilic at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Fibromyalgia Syndrome, Healthy Controls Group - Age and Sex-matched
What is being tested?: Observation only
How many people: 212 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 16 Dec 2024to 30 May 2025
How long will I take part?: 1 Month
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Yozgat, Yozgat, 66100

Other trials in Turkey (Türkiye)

About this study

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

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
Being tested: Observation only
Keywords: Fibromyalgia Syndrome, Artificial Intelligence Literacy, Electronic Health Literacy, Revised Fibromyalgia Impact Questionnaire, Beck Depression Inventory, Beck Anxiety Inventory
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07020845
Study group	Role	What they receive
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 Receives: 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 Receives: Other: Observation only

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: At baseline"

Secondary outcomes (3)

the Revised Fibromyalgia Impact Questionnaire
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 .
Measured: At baseline
the Beck Depression Inventory
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
Measured: At baseline
Beck Anxiety Inventory
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
Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 202430 May 2025

First posted13 Jun 2025
Study start16 Dec 2024
Primary completion30 May 2025
Study completion30 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 212 participants (actual)
Target duration: 1 Month

IDs, dates and publications

ClinicalTrials.gov ID: NCT07020845
Sponsor's protocol ID: 2024-GOKAEK-2411_2024.10.16_16
Status last verified: Jun 2025
First submitted: 3 Jun 2025
Last updated: 13 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All data and materials are available upon reasonable requests from the corresponding author

Publications

Çelebi, C., et al., Artificial intelligence literacy: An adaptation study. Instructional Technology and Lifelong Learning, 2023
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
TAMER GENCER, Z., Analysis of validity and reliability of Norman and Skinner's e-Health scale literacy for cultural adaptatio
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.
PubMed 16867972
Ulusoy, M., N.H. Sahin, and H. Erkmen, Turkish version of the Beck Anxiety Inventory: psychometric properties. Journal of cognitive psychotherapy, 1998
Hisli, N., Beck depresyon envanterinin universite ogrencileri icin gecerliligi, guvenilirlig
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.
PubMed 11149662
Karakilic GD, Balbaloglu O, Gocer S. Higher artificial intelligence literacy among patients with fibromyalgia syndrome: Results from a cross-sectional survey study. Reumatol Clin (Engl Ed). 2026 Mar;22(3):502098. doi: 10.1016/j.reumae.2026.502098.
PubMed 41932771

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fibromyalgia Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Investigation on Artificial Intelligence Literacy and E-Health Literacy of Patients With Fibromyalgia Syndrome
ClinicalTrials.gov ID: NCT07020845
Acronym / sponsor ID: 2024-GOKAEK-2411_2024.10.16_16
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
Study type: Observational
Recruitment status: Completed
Enrolment: 212 participants (actual)
Lead sponsor: Gulseren Demir KarakilicUniversity, hospital or other
Study start: 16 Dec 2024 (actual)
Primary completion: 30 May 2025 (actual)
Study completion: 30 May 2025 (actual)
First posted: 13 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Cross-sectional
Target follow-up: 1 Month
Number of arms: 2

Arm	Type	Receives
the patient group	–	Other: Observation onlyPatients 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
The control group	–	Other: Observation onlyThe 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

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
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.

Key inclusion criteria (6 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Observation onlyThis is an observational study with no intervention applied to participants. Data were collected through questionnaires and clinical assessments only	Other	The control group, the patient group

Primary outcome

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
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

3 secondary outcomes

the Revised Fibromyalgia Impact Questionnaire
Time frame: At baseline
the Beck Depression Inventory
Time frame: At baseline
Beck Anxiety Inventory
Time frame: At baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
BackgroundÇelebi, C., et al., Artificial intelligence literacy: An adaptation study. Instructional Technology and Lifelong Learning, 2023
BackgroundWang, 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
BackgroundTAMER GENCER, Z., Analysis of validity and reliability of Norman and Skinner's e-Health scale literacy for cultural adaptatio
Background: PubMed 16867972Norman 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.
BackgroundUlusoy, M., N.H. Sahin, and H. Erkmen, Turkish version of the Beck Anxiety Inventory: psychometric properties. Journal of cognitive psychotherapy, 1998
BackgroundHisli, N., Beck depresyon envanterinin universite ogrencileri icin gecerliligi, guvenilirlig
Background: PubMed 11149662Sarmer 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.
Derived from this study: PubMed 41932771Karakilic GD, Balbaloglu O, Gocer S. Higher artificial intelligence literacy among patients with fibromyalgia syndrome: Results from a cross-sectional survey study. Reumatol Clin (Engl Ed). 2026 Mar;22(3):502098. doi: 10.1016/j.reumae.2026.502098.
Individual participant dataSharing planned: Yes. All data and materials are available upon reasonable requests from the corresponding author

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Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gülseren Demir Karakılıç, Assistant Professor principal investigator

Yozgat Bozok University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Fibromyalgia Syndrome and Healthy Controls Group - Age and Sex-matched, run by Gulseren Demir Karakilic at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

E-Health Literacy (time frame: At baseline"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07020845, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.