FibromyalgiaNCT07846501
The Role of Pain Catastrophizing, Resilience, and Illness Perception in Predicting Fibromyalgia Impact in Patients With Fibromyalgia
An observational study of Fibromyalgia, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aims to reveal the effects of pain catastrophizing, psychological resilience, and illness perception on the impact level of fibromyalgia in patients with fibromyalgia, to determine the predictive power of these psychosocial variables regarding the impact level of fibromyalgia, and to evaluate their roles in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2026to 1 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with fibromyalgia
Who may be able to join
- Patients diagnosed with fibromyalgia,
- Aged 18 years or older,
- Literate in Turkish,
- And without communication difficulties.
Who cannot join
- Those with a disease causing cognitive impairment who are unable to answer the survey questions,
- Those with chronic painful medical conditions other than fibromyalgia (e.g., migraine, diabetic neuropathy, rheumatoid arthritis, etc.),
- Those diagnosed with neurocognitive, mental, or emotional disorders,
- Patients with multisystemic diseases such as cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bilecik Seyh Edebali University
Bilecik, Bilecik, 11000
About this study
This study aims to reveal the effects of pain catastrophizing, psychological resilience, and illness perception on the impact level of fibromyalgia in patients with fibromyalgia, to determine the predictive power of these psychosocial variables regarding the impact level of fibromyalgia, and to evaluate their roles in explaining the burden of the disease.
Read the detailed description
While pain catastrophizing, resilience, and illness perception have been examined separately in patients with fibromyalgia, studies evaluating the extent to which these variables collectively predict the impact of the disease are limited. Addressing pain catastrophizing and negative illness perception as risk factors, alongside resilience as a protective factor, within a single model will contribute to a more holistic explanation of the disease burden experienced by fibromyalgia patients. The results of this study are expected to enhance the understanding of the psychosocial factors that determine the impact of the disease on fibromyalgia patients. Furthermore, the findings are anticipated to provide a scientific basis for the development of psychoeducation, cognitive-behavioral counseling, resilience-supporting interventions, and individualized care plans by nurses and other healthcare professionals. In this regard, the study will contribute to strengthening the biopsychosocial approach to fibromyalgia management and to the planning of patient-centered care practices.
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Resilience Perception, Pain Catastrophizing, Illness Perception
- Medical subject headings
- Fibromyalgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
VAS (Visual Analog Scale): A scale consisting of a 10 cm horizontal line marked at equal intervals, with one end representing "no pain" and the other "unbearable pain." The patient is asked to mark the point on the line that best represents the intensity of their pain. This distance, measured in millimeters, is interpreted as a "score." Regarding pain intensity, a score of 0 is rated as "no pain," while a score of 10 is rated as "unbearable, worst possible pain."
Measured: 1 days
Revised Fibromyalgia Impact Questionnaire
Revised Fibromyalgia Impact Questionnaire (FIQR): This questionnaire was updated by Bennett et al. in 2009. It consists of 21 separate questions, all rated on a scale of 0 to 10; a score of 10 represents the worst possible state, while 0 indicates the absence of the complaint. The questionnaire comprises three sub-dimensions: "function" (9 questions), "overall impact" (2 questions), and "symptoms" (10 questions). The total score for function (range 0-90) is divided by 3, the total score for overall impact (range 0-20) remains unchanged, and the total score for symptoms (range 0-100) is divided by 2. The total questionnaire score (0-100) is the sum of these values. A higher score indicates a high level of impact from the disease. The recommended cut-off points for disease severity are as follows: 0-23, remission; 24-40, mild disease; 41-63, moderate disease; 64-82, severe disease; and 83-100, very severe disease. The Cronbach's alpha for the FIQR is 0.95, and item-total correlations ra
Measured: 1 days
The Pain Catastrophizing Scale
The Pain Catastrophizing Scale is a 13-item self-report scale developed by Sullivan et al. to assess the extent to which individuals tend to catastrophize in response to pain; it utilizes a 5-point Likert-type rating system (scoring 0-4). The original form of the scale comprises three sub-dimensions: helplessness, magnification, and rumination. The internal consistency reliability of the Turkish adaptation of the Pain Catastrophizing Scale was found to be very high, with a Cronbach's alpha coefficient of 0.955. Item-total and inter-item correlation coefficients for the scale were determined to range between 0.488 and 0.848.
Measured: 1 days
Brief Illness Perception Questionnaire
Brief Illness Perception Questionnaire: Developed by Broadbent et al. in 2006. This scale comprises 8 items plus an additional item investigating causal factors. With the exception of the ninth item regarding causal factors, the eight items on the scale use a Likert-type scoring system ranging from 0 to 10. The first five items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two items assess emotional illness perceptions: concern (Item 6) and emotions (Item 8). One item evaluates illness coherence (Item 7). Causal representation is assessed via an open-ended question asking patients to list the most important causal factors of their illness (Item 9). Scores on the scale indicate the perceived threat of the illness or the individual's level of ease regarding the condition. When calculating the score, the values for items 3, 4, and 7 are reversed and added to the scores of
Measured: 1 days
Brief Resilience Scale
Brief Resilience Scale: This scale was developed by Smith et al. (2008) to measure individuals' psychological resilience. It is a 6-item, self-report instrument using a 5-point Likert scale. Items 2, 4, and 6 are reverse-coded. After reversing the scores for these items, high total scores indicate a high level of psychological resilience. The internal consistency reliability of the Turkish adaptation of the scale was found to be .83.
Measured: 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start16 Sep 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion1 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semanur Bilgiç, Bilecik Seyh Edebali Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846501
- Sponsor's protocol ID
- FM Ağrı Çalışması
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pain Catastrophizing, Resilience, and Illness Perception in Predicting Fibromyalgia Impact in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07846501
- Acronym / sponsor ID
- FM Ağrı Çalışması
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Resilience Perception, Pain Catastrophizing, Illness Perception
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 16 Sep 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 29 Sep 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.
This study aims to reveal the effects of pain catastrophizing, psychological resilience, and illness perception on the impact level of fibromyalgia in patients with fibromyalgia, to determine the predictive power of these psychosocial variables regarding the impact level of fibromyalgia, and to evaluate their roles in explaining the burden of the disease.
Detailed description
While pain catastrophizing, resilience, and illness perception have been examined separately in patients with fibromyalgia, studies evaluating the extent to which these variables collectively predict the impact of the disease are limited. Addressing pain catastrophizing and negative illness perception as risk factors, alongside resilience as a protective factor, within a single model will contribute to a more holistic explanation of the disease burden experienced by fibromyalgia patients. The results of this study are expected to enhance the understanding of the psychosocial factors that determine the impact of the disease on fibromyalgia patients. Furthermore, the findings are anticipated to provide a scientific basis for the development of psychoeducation, cognitive-behavioral counseling, resilience-supporting interventions, and individualized care plans by nurses and other healthcare professionals. In this regard, the study will contribute to strengthening the biopsychosocial approach to fibromyalgia management and to the planning of patient-centered care practices.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with fibromyalgia
Key inclusion criteria (4 listed)
- Patients diagnosed with fibromyalgia,
- Aged 18 years or older,
- Literate in Turkish,
- And without communication difficulties.
Key exclusion criteria (4 listed)
- Those with a disease causing cognitive impairment who are unable to answer the survey questions,
- Those with chronic painful medical conditions other than fibromyalgia (e.g., migraine, diabetic neuropathy, rheumatoid arthritis, etc.),
- Those diagnosed with neurocognitive, mental, or emotional disorders,
- Patients with multisystemic diseases such as cancer.
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
Visual Analog Scale
Time frame: 1 days
VAS (Visual Analog Scale): A scale consisting of a 10 cm horizontal line marked at equal intervals, with one end representing "no pain" and the other "unbearable pain." The patient is asked to mark the point on the line that best represents the intensity of their pain. This distance, measured in millimeters, is interpreted as a "score." Regarding pain intensity, a score of 0 is rated as "no pain," while a score of 10 is rated as "unbearable, worst possible pain."
Revised Fibromyalgia Impact Questionnaire
Time frame: 1 days
Revised Fibromyalgia Impact Questionnaire (FIQR): This questionnaire was updated by Bennett et al. in 2009. It consists of 21 separate questions, all rated on a scale of 0 to 10; a score of 10 represents the worst possible state, while 0 indicates the absence of the complaint. The questionnaire comprises three sub-dimensions: "function" (9 questions), "overall impact" (2 questions), and "symptoms" (10 questions). The total score for function (range 0-90) is divided by 3, the total score for overall impact (range 0-20) remains unchanged, and the total score for symptoms (range 0-100) is divided by 2. The total questionnaire score (0-100) is the sum of these values. A higher score indicates a high level of impact from the disease. The recommended cut-off points for disease severity are as follows: 0-23, remission; 24-40, mild disease; 41-63, moderate disease; 64-82, severe disease; and 83-100, very severe disease. The Cronbach's alpha for the FIQR is 0.95, and item-total correlations ra
The Pain Catastrophizing Scale
Time frame: 1 days
The Pain Catastrophizing Scale is a 13-item self-report scale developed by Sullivan et al. to assess the extent to which individuals tend to catastrophize in response to pain; it utilizes a 5-point Likert-type rating system (scoring 0-4). The original form of the scale comprises three sub-dimensions: helplessness, magnification, and rumination. The internal consistency reliability of the Turkish adaptation of the Pain Catastrophizing Scale was found to be very high, with a Cronbach's alpha coefficient of 0.955. Item-total and inter-item correlation coefficients for the scale were determined to range between 0.488 and 0.848.
Brief Illness Perception Questionnaire
Time frame: 1 days
Brief Illness Perception Questionnaire: Developed by Broadbent et al. in 2006. This scale comprises 8 items plus an additional item investigating causal factors. With the exception of the ninth item regarding causal factors, the eight items on the scale use a Likert-type scoring system ranging from 0 to 10. The first five items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two items assess emotional illness perceptions: concern (Item 6) and emotions (Item 8). One item evaluates illness coherence (Item 7). Causal representation is assessed via an open-ended question asking patients to list the most important causal factors of their illness (Item 9). Scores on the scale indicate the perceived threat of the illness or the individual's level of ease regarding the condition. When calculating the score, the values for items 3, 4, and 7 are reversed and added to the scores of
Brief Resilience Scale
Time frame: 1 days
Brief Resilience Scale: This scale was developed by Smith et al. (2008) to measure individuals' psychological resilience. It is a 6-item, self-report instrument using a 5-point Likert scale. Items 2, 4, and 6 are reverse-coded. After reversing the scores for these items, high total scores indicate a high level of psychological resilience. The internal consistency reliability of the Turkish adaptation of the scale was found to be .83.
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 29 Sep 2026.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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, run by Bilecik Seyh Edebali Universitesi 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 4 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: enrolling by invitation, as of the sponsor's last update on 29 Sep 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?
Visual Analog Scale (time frame: 1 days). The study lists 5 primary outcomes in all. 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 29 Sep 2026.