Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 11:15 AM
Study NCT ID:
NCT07446504
Status:
COMPLETED
Last Update Posted:
2026-03-03
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Pain With Body Image and Psychological Resilience in Rheumatoid Arthritis and Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Image Perception', 'timeFrame': 'At enrollment (single visit).', 'description': 'Body image perception measured using the Body Image Scale; scores will be compared between rheumatoid arthritis, fibromyalgia, and healthy control groups.'}, {'measure': 'Body Image Perception', 'timeFrame': 'At enrollment (single visit).', 'description': 'Body image perception measured by the Body Image Scale (BIS); comparison of BIS scores between rheumatoid arthritis, fibromyalgia, and healthy control groups.'}], 'secondaryOutcomes': [{'measure': 'Psychological Resilience (Connor-Davidson Resilience Scale, CD-RISC)', 'timeFrame': 'At enrollment (single visit).', 'description': 'Psychological resilience assessed using the Connor-Davidson Resilience Scale (CD-RISC); scores compared between groups and correlated with BIS.'}, {'measure': 'Somatosensory Amplification (Somatosensory Amplification Scale, SAS)', 'timeFrame': 'At enrollment (single visit).', 'description': 'Tendency to amplify bodily sensations assessed using the Somatosensory Amplification Scale (SAS); scores compared between groups and analyzed for association with BIS.'}, {'measure': 'Depressive Symptoms (Beck Depression Inventory, BDI)', 'timeFrame': 'At enrollment (single visit).', 'description': 'Depressive symptom severity assessed using the Beck Depression Inventory (BDI); scores compared between groups and analyzed for association with BIS.'}, {'measure': 'Two-Point Discrimination Threshold (2PD)', 'timeFrame': 'At enrollment (single visit).', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Widespread Pain, Resilience, Body Image, Quality of Life'], 'conditions': ['Rheumatoid Arthritis , Fibromyalgia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nObjective: 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.\n\nDesign and Setting: Cross-sectional, comparative study conducted in the Physical Medicine and Rehabilitation Clinic at Samsun Training and Research Hospital.\n\nParticipants: 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.\n\nProcedures 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.\n\nSample Size: Power analysis (G\\*Power) indicated a minimum total sample size of approximately 102 participants (34 per group).\n\nStatistical 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Adults aged 18-70 years.\n* For the fibromyalgia group: meeting the ACR 2016 criteria.\n* For the rheumatoid arthritis group: meeting the ACR classification/diagnostic criteria.\n* For the healthy control group: no history of chronic pain or chronic disease.\n* Willingness to participate and provision of written informed consent.\n\nExclusion Criteria\n\n* Presence of an acute or chronic neurological disease.\n* Current or past psychiatric diagnosis.\n* Severe visual or hearing impairment.\n* History of trauma or surgery within the past 6 months.\n* History of cancer.\n* Thyroid disease.\n* Refusal to participate / inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07446504', 'briefTitle': 'Association of Pain With Body Image and Psychological Resilience in Rheumatoid Arthritis and Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Samsun University'}, 'officialTitle': 'The Relationship Between Pain, Psychological Resilience, and Body Image Perception in Patients With Rheumatoid Arthritis and Fibromyalgia: A Cross-Sectional Comparative Study', 'orgStudyIdInfo': {'id': 'SAMU/2025/5/12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid Arthritis (RA)', 'description': 'Adults aged 18-65 with rheumatoid arthritis meeting ACR criteria; disease activity assessed by DAS28.'}, {'label': 'Fibromyalgia', 'description': 'Adults aged 18-65 with fibromyalgia meeting ACR 2016 criteria.'}, {'label': 'Healthy Controls', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55090', 'city': 'Samsun', 'state': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Samsun Training and Research Hospital, Physical Medicine and Rehabilitation Clinic', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'ipek can okutan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'samsun univercity'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared publicly to protect participant privacy and confidentiality. Only de-identified, aggregated results will be reported'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsun University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor.', 'investigatorFullName': 'ipek Can Okutan', 'investigatorAffiliation': 'Samsun University'}}}}