跳至主要内容
临床试验/NCT07446504
NCT07446504已完成不适用

The Relationship Between Pain, Psychological Resilience, and Body Image Perception in Patients With Rheumatoid Arthritis and Fibromyalgia: A Cross-Sectional Comparative Study

Samsun University1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
124
试验地点
1
主要终点
Body Image Perception

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

结局指标

主要结局

Body Image Perception

时间窗: 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.

次要结局

  • Psychological Resilience (Connor-Davidson Resilience Scale, CD-RISC)(At enrollment (single visit).)
  • Somatosensory Amplification (Somatosensory Amplification Scale, SAS)(At enrollment (single visit).)
  • Depressive Symptoms (Beck Depression Inventory, BDI)(At enrollment (single visit).)
  • Two-Point Discrimination Threshold (2PD)(At enrollment (single visit).)

研究者

发起方
Samsun University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ipek Can Okutan

Assistant Professor.

Samsun University

研究点 (1)

Loading locations...

相似试验

Association of Pain With Body Image and... | 临床试验