FibromyalgiaNCT07662993
Factors Associated With Cognitive Skills in Patients With Fibromyalgia
An observational study of Fibromyalgia and Cognition, run by Zülal TATAR at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to identify factors associated with cognitive skills in female patients with fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia, Cognition
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2026to 12 Sep 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- Adult, Older adult
Study population: At least 41 female fibromyalgia patients aged 18-65 years who are followed by Pamukkale University Rheumatology Clinic, diagnosed according to the 2011 American Rheumatology Association Fibromyalgia classification criteria, and who meet the inclusion criteria will be included in the study.
Who may be able to join
- Being between 18-65 years of age
- Being female
- Having been diagnosed with fibromyalgia for at least 6 months, with the appearance of a range of somatic and cognitive symptoms in addition to widespread pain.
Who cannot join
- Having another illness that affects their physical condition
- Having cognitive impairment to the extent that they cannot cooperate
- Being pregnant
- Impaired Turkish language comprehension or speech
- Concurrent autoimmune or inflammatory disease
- Diseases affecting the central nervous system (e.g., multiple sclerosis, Parkinson's disease)
- Serious psychiatric conditions that prevent participation (e.g., psychotic disorders).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Identifying Factors Associated With Cognitive Skills in Female Patients With Fibromyalgia
The aim of this study was to identify factors associated with cognitive skills in female patients with fibromyalgia.
- Conditions
- Fibromyalgia, Cognition
- Medical subject headings
- Fibromyalgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Loewenstein Occupational Therapy Cognitive Assessment (DLOTCA)
DLOTCA assesses the basic cognitive skills of individuals aged 18-69 years using 28 subtests across 7 cognitive domains (Awareness, Orientation, Spatial Perception, Visual Perception, Visual-Motor Structuring, Application, and Thinking Processes) (13). Each subtest has 3 scoring stages:
First stage: Pre-mediation scoring (1 point indicates the worst performance). Second stage: Mediation score (a high score (4 or 5) indicates poor performance). Third stage: Post-mediation scoring (1 point indicates the worst performance).
Measured: At baseline (Day 1)
Secondary outcomes (7)
Fibromyalgia Impact Questionnaire
This physical impact scale, administered to patients, was developed by Burchardt et al. to measure functional status in fibromyalgia patients. The scale primarily measures 10 separate characteristics: physical function, well-being, inability to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety, and depression. Except for well-being, lower scores indicate improvement or less severe impact from the disease. Each subcategory can have a maximum score of 10, resulting in a total maximum score of 100.
Measured: At Baseline (Day 1)
Pressure Pain Threshold Measurements
Pressure pain threshold measurements will be assessed using a pressure algometer, a gun-shaped apparatus with a 1-cm² rigid rubber probe held at a 90-degree angle to the body and then applying pressure at a constant rate of increasing pressure (30 kPa/s) until the patient's pain threshold is reached. The assessment will be performed bilaterally in 4 different regions, one assessment per anatomical region: trapezius muscle, elbows (lateral epicondyle), quadriceps femoris muscle, and knees (in the medial fat pad near the joint line). For each participant, the total mean pressure pain threshold measurements will be calculated and used for analysis. Sensitive points will be determined according to the guidelines of Okifuji et al. Previous studies have shown that assessing pressure pain threshold measurements in a limited number of regions provides a good estimate of overall sensitivity.
Measured: At baseline (Day 1)
Cognitive Exercise Therapy Approach Scale
The Cognitive Exercise Therapy Approach Scale assesses the biopsychosocial status of patients with rheumatic diseases. The total score ranges from 0 to 120. Higher scores indicate a worse biopsychosocial status.
Measured: At baseline (Day 1)
Tampa Kinesiophobia Scale
The original Tampa Kinesiophobia Scale was developed by Miller, Kopri and Todd in 1991, but was not published. Vlaeyen et al. republished the original scale, consisting of 17 questions, in 1995, with the permission of the researchers who developed it. TAS is a 17-question scale developed to measure fear of movement/re-injury. The scale includes injury/re-injury and fear-avoidance parameters in work-related activities.
Measured: At Baseline (Day 1)
Pain Catastrophizing Scale:
Developed to identify patients' catastrophic thoughts or feelings about the pain they experience and their ineffective coping strategies, this scale is a thirteen-item Likert-type self-assessment scale. Each item is scored between 0 and 4. The total score ranges from 0 to 52. Higher scores indicate a high level of catastrophizing.
Measured: At baseline (Day 1)
The Short Pain Inventory
The Short Pain Inventory is a short, easy-to-administer assessment method that can be used to evaluate pain. It includes numerical rating scales from 0 to 10. In the Short Pain Inventory, the worst pain is defined as mild (1-4), moderate (5-6), and severe (7-10). It assesses the severity of pain, its localization, medical treatments for pain, and its impact on daily functions, and asks how much pain has decreased in the last 24 hours or the past week. Answering all questions takes a short time, approximately 5-10 minutes.
Measured: At baseline (Day 1)
Generalized Pain Index and Symptom Severity Scale
The Generalized Pain Index is an index that assesses a patient's pain in 19 regions over the past week. The Symptom Severity Scale consists of 3 questions: fatigue, difficulty thinking and remembering, and sleeplessness. The severity of each of these 3 complaints over the past week is scored using a scale from 0: no problem, 1: mild problem, 2: moderate problem, 3: severe problem.
Measured: At baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start12 May 2026
- Primary completion12 Aug 2027 (estimated)
- Study completion12 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Prospective
- Enrolment
- 41 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Zülal TATAR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zülal TATAR, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662993
- Sponsor's protocol ID
- Fibromyalgia Cognition
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Factors Associated With Cognitive Skills in Female Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07662993
- Acronym / sponsor ID
- Fibromyalgia Cognition
- Conditions
- Fibromyalgia, Cognition
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Zülal TATARUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- 12 Aug 2027 (estimated)
- Study completion
- 12 Sep 2027 (estimated)
- First posted
- 23 Jun 2026 (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.
The aim of this study was to identify factors associated with cognitive skills in female patients with fibromyalgia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- At least 41 female fibromyalgia patients aged 18-65 years who are followed by Pamukkale University Rheumatology Clinic, diagnosed according to the 2011 American Rheumatology Association Fibromyalgia classification criteria, and who meet the inclusion criteria will be included in the study.
Key inclusion criteria (3 listed)
- Being between 18-65 years of age
- Being female
- Having been diagnosed with fibromyalgia for at least 6 months, with the appearance of a range of somatic and cognitive symptoms in addition to widespread pain.
Key exclusion criteria (7 listed)
- Having another illness that affects their physical condition
- Having cognitive impairment to the extent that they cannot cooperate
- Being pregnant
- Impaired Turkish language comprehension or speech
- Concurrent autoimmune or inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dynamic Loewenstein Occupational Therapy Cognitive Assessment (DLOTCA)
Time frame: At baseline (Day 1)
DLOTCA assesses the basic cognitive skills of individuals aged 18-69 years using 28 subtests across 7 cognitive domains (Awareness, Orientation, Spatial Perception, Visual Perception, Visual-Motor Structuring, Application, and Thinking Processes) (13). Each subtest has 3 scoring stages: First stage: Pre-mediation scoring (1 point indicates the worst performance). Second stage: Mediation score (a high score (4 or 5) indicates poor performance). Third stage: Post-mediation scoring (1 point indicates the worst performance).
7 secondary outcomes
Fibromyalgia Impact Questionnaire
Time frame: At Baseline (Day 1)
Pressure Pain Threshold Measurements
Time frame: At baseline (Day 1)
Cognitive Exercise Therapy Approach Scale
Time frame: At baseline (Day 1)
Tampa Kinesiophobia Scale
Time frame: At Baseline (Day 1)
Pain Catastrophizing Scale:
Time frame: At baseline (Day 1)
The Short Pain Inventory
Time frame: At baseline (Day 1)
Generalized Pain Index and Symptom Severity Scale
Time frame: At baseline (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Cognition, run by Zülal TATAR 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 3 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 23 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Dynamic Loewenstein Occupational Therapy Cognitive Assessment (DLOTCA) (time frame: At baseline (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2026.