Rheumatoid Arthritis , FibromyalgiaNCT07446504
Association of Pain With Body Image and Psychological Resilience in Rheumatoid Arthritis and Fibromyalgia
An observational study of Rheumatoid Arthritis , Fibromyalgia, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional, comparative study will examine the relationship between psychological resilience and body image in patients with rheumatoid arthritis (RA) and fibromyalgia (FM), and compare these findings with healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis , Fibromyalgia
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 30 Sep 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 18-65 years will be recruited from the Physical Medicine and Rehabilitation outpatient clinic at Samsun Training and Research Hospital. The study population will include patients with rheumatoid arthritis (meeting ACR criteria), patients with fibromyalgia (meeting ACR 2016 criteria), and healthy controls without a history of chronic pain or chronic disease. All participants will provide written informed consent.
Who may be able to join
- Adults aged 18-70 years.
- For the fibromyalgia group: meeting the ACR 2016 criteria.
- For the rheumatoid arthritis group: meeting the ACR classification/diagnostic criteria.
- For the healthy control group: no history of chronic pain or chronic disease.
- Willingness to participate and provision of written informed consent.
Who cannot join
- Presence of an acute or chronic neurological disease.
- Current or past psychiatric diagnosis.
- Severe visual or hearing impairment.
- History of trauma or surgery within the past 6 months.
- History of cancer.
- Thyroid disease.
- Refusal to participate / inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Training and Research Hospital, Physical Medicine and Rehabilitation Clinic
Samsun, Samsun, 55090
About this study
Official title: The Relationship Between Pain, Psychological Resilience, and Body Image Perception in Patients With Rheumatoid Arthritis and Fibromyalgia: A Cross-Sectional Comparative Study
This cross-sectional, comparative study will examine the relationship between psychological resilience and body image in patients with rheumatoid arthritis (RA) and fibromyalgia (FM), and compare these findings with healthy controls. Participants will be recruited consecutively from the Physical Medicine and Rehabilitation outpatient clinic at Samsun Training and Research Hospital. After informed consent, demographic and clinical information will be recorded and validated questionnaires will be administered. The results may help to better understand psychological and body-related experiences in RA and FM and support more comprehensive patient care.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic inflammatory painful disease frequently accompanied by persistent pain, functional limitations, fatigue, and psychological distress. Fibromyalgia (FM) is characterized by chronic widespread pain and multiple symptoms including fatigue, non-restorative sleep, and cognitive complaints; psychological and social factors may also contribute to symptom burden. In both conditions, altered pain processing and central sensitization may influence symptom severity and daily functioning. Body image refers to an individual's perceptions, feelings, and thoughts about their own body, including appearance and physical functioning; chronic pain and disability can negatively affect body image and quality of life.
Objective: The primary aim of this study is to investigate, in a cross-sectional and comparative manner, the association between psychological resilience and body image in RA and FM, and to compare results with a healthy control group.
Design and Setting: Cross-sectional, comparative study conducted in the Physical Medicine and Rehabilitation Clinic at Samsun Training and Research Hospital.
Participants: Adults aged 18-65 years. The study will include approximately 42 participants with FM (meeting ACR 2016 criteria), 42 participants with RA (meeting ACR criteria; disease activity assessed using DAS28), and 40 healthy controls without a history of chronic pain or chronic disease.
Procedures and Measures: After written informed consent, demographic variables (age, sex, height, weight, body mass index, occupation, education), comorbidities, and medication use will be recorded. Participants will complete validated instruments including the Connor-Davidson Resilience Scale (CD-RISC), Body Image Scale (BIS), Beck Depression Inventory (BDI), Central Sensitization Inventory (CSI), Short Form-36 (SF-36), Somatosensory Amplification Scale (SAS), and the Revised Fibromyalgia Impact Questionnaire (FIQR) (FM group). Somatosensory assessment will be performed using the Two-Point Discrimination test. RA disease activity will be evaluated using DAS28.
Sample Size: Power analysis (G*Power) indicated a minimum total sample size of approximately 102 participants (34 per group).
Statistical Analysis: Group comparisons will be performed using appropriate parametric or non-parametric tests based on data distribution. Associations between resilience, body image, central sensitization, sensory measures, and quality-of-life outcomes will be assessed using correlation analyses. A p-value <0.05 will be considered statistically significant.
- Conditions
- Rheumatoid Arthritis , Fibromyalgia
- Keywords
- Chronic Widespread Pain, Resilience, Body Image, Quality of Life
- Medical subject headings
- Arthritis, Rheumatoid, Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis (RA) | Adults aged 18-65 with rheumatoid arthritis meeting ACR criteria; disease activity assessed by DAS28. | |
| Fibromyalgia | Adults aged 18-65 with fibromyalgia meeting ACR 2016 criteria. | |
| Healthy Controls | Adults aged 18-65 presenting to the Physical Medicine and Rehabilitation outpatient clinic for various reasons, without known sleep disorders, psychiatric disorders, or rheumatologic disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Image Perception
Body image perception measured using the Body Image Scale; scores will be compared between rheumatoid arthritis, fibromyalgia, and healthy control groups.
Measured: At enrollment (single visit).
Body Image Perception
Body image perception measured by the Body Image Scale (BIS); comparison of BIS scores between rheumatoid arthritis, fibromyalgia, and healthy control groups.
Measured: At enrollment (single visit).
Secondary outcomes (4)
Psychological Resilience (Connor-Davidson Resilience Scale, CD-RISC)
Psychological resilience assessed using the Connor-Davidson Resilience Scale (CD-RISC); scores compared between groups and correlated with BIS.
Measured: At enrollment (single visit).
Somatosensory Amplification (Somatosensory Amplification Scale, SAS)
Tendency to amplify bodily sensations assessed using the Somatosensory Amplification Scale (SAS); scores compared between groups and analyzed for association with BIS.
Measured: At enrollment (single visit).
Depressive Symptoms (Beck Depression Inventory, BDI)
Depressive symptom severity assessed using the Beck Depression Inventory (BDI); scores compared between groups and analyzed for association with BIS.
Measured: At enrollment (single visit).
Two-Point Discrimination Threshold (2PD)
Somatosensory function assessed by the Two-Point Discrimination test; discrimination threshold values will be compared between groups and analyzed for association with Body Image Scale scores and Central Sensitization Inventory scores.
Measured: At enrollment (single visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Apr 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis , 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ipek Can Okutan, Samsun University
- Investigators
- ipek can okutan, MD, Principal investigator, samsun univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446504
- Sponsor's protocol ID
- SAMU/2025/5/12
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly to protect participant privacy and confidentiality. Only de-identified, aggregated results will be reported
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Pain, Psychological Resilience, and Body Image Perception in Patients With Rheumatoid Arthritis and Fibromyalgia: A Cross-Sectional Comparative Study
- ClinicalTrials.gov ID
- NCT07446504
- Acronym / sponsor ID
- SAMU/2025/5/12
- Conditions
- Rheumatoid Arthritis , Fibromyalgia
- Keywords
- Chronic Widespread Pain, Resilience, Body Image, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 3 Mar 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 cross-sectional, comparative study will examine the relationship between psychological resilience and body image in patients with rheumatoid arthritis (RA) and fibromyalgia (FM), and compare these findings with healthy controls. Participants will be recruited consecutively from the Physical Medicine and Rehabilitation outpatient clinic at Samsun Training and Research Hospital. After informed consent, demographic and clinical information will be recorded and validated questionnaires will be administered. The results may help to better understand psychological and body-related experiences in RA and FM and support more comprehensive patient care.
Detailed description
Rheumatoid arthritis (RA) is a chronic inflammatory painful disease frequently accompanied by persistent pain, functional limitations, fatigue, and psychological distress. Fibromyalgia (FM) is characterized by chronic widespread pain and multiple symptoms including fatigue, non-restorative sleep, and cognitive complaints; psychological and social factors may also contribute to symptom burden. In both conditions, altered pain processing and central sensitization may influence symptom severity and daily functioning. Body image refers to an individual's perceptions, feelings, and thoughts about their own body, including appearance and physical functioning; chronic pain and disability can negatively affect body image and quality of life.
Objective: The primary aim of this study is to investigate, in a cross-sectional and comparative manner, the association between psychological resilience and body image in RA and FM, and to compare results with a healthy control group.
Design and Setting: Cross-sectional, comparative study conducted in the Physical Medicine and Rehabilitation Clinic at Samsun Training and Research Hospital.
Participants: Adults aged 18-65 years. The study will include approximately 42 participants with FM (meeting ACR 2016 criteria), 42 participants with RA (meeting ACR criteria; disease activity assessed using DAS28), and 40 healthy controls without a history of chronic pain or chronic disease.
Procedures and Measures: After written informed consent, demographic variables (age, sex, height, weight, body mass index, occupation, education), comorbidities, and medication use will be recorded. Participants will complete validated instruments including the Connor-Davidson Resilience Scale (CD-RISC), Body Image Scale (BIS), Beck Depression Inventory (BDI), Central Sensitization Inventory (CSI), Short Form-36 (SF-36), Somatosensory Amplification Scale (SAS), and the Revised Fibromyalgia Impact Questionnaire (FIQR) (FM group). Somatosensory assessment will be performed using the Two-Point Discrimination test. RA disease activity will be evaluated using DAS28.
Sample Size: Power analysis (G*Power) indicated a minimum total sample size of approximately 102 participants (34 per group).
Statistical Analysis: Group comparisons will be performed using appropriate parametric or non-parametric tests based on data distribution. Associations between resilience, body image, central sensitization, sensory measures, and quality-of-life outcomes will be assessed using correlation analyses. A p-value <0.05 will be considered statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis (RA) | – | –Adults aged 18-65 with rheumatoid arthritis meeting ACR criteria; disease activity assessed by DAS28. |
| Fibromyalgia | – | –Adults aged 18-65 with fibromyalgia meeting ACR 2016 criteria. |
| Healthy Controls | – | –Adults aged 18-65 presenting to the Physical Medicine and Rehabilitation outpatient clinic for various reasons, without known sleep disorders, psychiatric disorders, or rheumatologic disease. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18-65 years will be recruited from the Physical Medicine and Rehabilitation outpatient clinic at Samsun Training and Research Hospital. The study population will include patients with rheumatoid arthritis (meeting ACR criteria), patients with fibromyalgia (meeting ACR 2016 criteria), and healthy controls without a history of chronic pain or chronic disease. All participants will provide written informed consent.
Key inclusion criteria (5 listed)
- Adults aged 18-70 years.
- For the fibromyalgia group: meeting the ACR 2016 criteria.
- For the rheumatoid arthritis group: meeting the ACR classification/diagnostic criteria.
- For the healthy control group: no history of chronic pain or chronic disease.
- Willingness to participate and provision of written informed consent.
Key exclusion criteria (7 listed)
- Presence of an acute or chronic neurological disease.
- Current or past psychiatric diagnosis.
- Severe visual or hearing impairment.
- History of trauma or surgery within the past 6 months.
- History of 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
Body Image Perception
Time frame: At enrollment (single visit).
Body image perception measured using the Body Image Scale; scores will be compared between rheumatoid arthritis, fibromyalgia, and healthy control groups.
Body Image Perception
Time frame: At enrollment (single visit).
Body image perception measured by the Body Image Scale (BIS); comparison of BIS scores between rheumatoid arthritis, fibromyalgia, and healthy control groups.
4 secondary outcomes
Psychological Resilience (Connor-Davidson Resilience Scale, CD-RISC)
Time frame: At enrollment (single visit).
Somatosensory Amplification (Somatosensory Amplification Scale, SAS)
Time frame: At enrollment (single visit).
Depressive Symptoms (Beck Depression Inventory, BDI)
Time frame: At enrollment (single visit).
Two-Point Discrimination Threshold (2PD)
Time frame: At enrollment (single visit).
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 3 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly to protect participant privacy and confidentiality. Only de-identified, aggregated results will be reported
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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.
ipek can okutan, MD principal investigator
samsun univercity
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 Rheumatoid Arthritis , Fibromyalgia, run by Samsun University 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 5 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: finished, as of the sponsor's last update on 3 Mar 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?
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?
Body Image Perception (time frame: At enrollment (single visit).). 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?
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 3 Mar 2026.