CClinicalTrials.gg
CompletedNCT07446504Updated Mar 3, 2026

Association of Pain With Body Image and Psychological Resilience in Rheumatoid Arthritis and Fibromyalgia

An observational study in Rheumatoid Arthritis , Fibromyalgia, sponsored by Samsun University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Samsun University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
124
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Rheumatoid Arthritis , Fibromyalgia

Keywords

  • Chronic Widespread Pain, Resilience, Body Image, Quality of Life
03

In context

Arthritis, Rheumatoid

2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.

This study's enrollment of 124 is below the median of 176 across 824 observational studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Samsun University is the lead sponsor of 81 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
124 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Body Image Perception

    Body image perception measured using the Body Image Scale; scores will be compared between rheumatoid arthritis, fibromyalgia, and healthy control groups.

    Time frame: At enrollment (single visit).

  2. 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.

    Time frame: At enrollment (single visit).

Secondary outcomes

  1. 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.

    Time frame: At enrollment (single visit).

  2. 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.

    Time frame: At enrollment (single visit).

  3. 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.

    Time frame: At enrollment (single visit).

  4. 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.

    Time frame: At enrollment (single visit).

07

Study locations

1 site
  • Samsun Training and Research Hospital, Physical Medicine and Rehabilitation Clinic
    Samsun, Samsun 55090, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared publicly to protect participant privacy and confidentiality. Only de-identified, aggregated results will be reported

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07446504
Lead sponsor
Samsun University
Responsible party
ipek Can Okutan (Assistant Professor., Samsun University) — Principal investigator
First posted
Mar 3, 2026
Start date
Apr 1, 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025
Last update
Mar 3, 2026

Study contacts

ipek can okutan, MD
principal investigator · samsun univercity

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion