The Role of Central Sensitization on Biopsychosocial Factors in Primary Sjögren's Syndrome

NCT ID: NCT06410742

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-19
• Study Completion Date: 2025-01-01

Brief Summary

Following the guidance of individuals with primary Sjögren's Syndrome who receive diagnosis, routine medical care, and treatment management, the evaluations will be performed once by the researchers and will take approximately one hour.

In addition, healthy individuals with a similar average age to the evaluation group without any disease diagnosis will be included in the study as a control group. Evaluations of the healthy group will be made once by the researchers and will take approximately one hour.

Data will be collected face to face at the Faculty of Physical Therapy and Rehabilitation, Rheumatology Unit.

Data collection tool of the research:

• Information about patients will be recorded with the Demographic Information Form.
• EULAR Sjögren's Syndrome Disease Activity Index
• EULAR Sjögren's Syndrome Patient Reporting Index
• Primary Sjögren's Syndrome Quality of Life Scale
• BETY-Biopsychosocial Questionnaire
• Central Sensitization Scale
• Pain Catastrophizing Scale
• Hospital Anxiety and Depression Scale
• Multidimensional Fatigue Rating Scale
• Turkish Eating Assessment Tool
• Yale Swallow Protocol
• Test of Mastication and Swallowing Solids
• Dysphagia Limit Test
• Xerostomia inventory

Conditions

Sjogren's Syndrome

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with primer Sjogren's syndrome

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with Primary Sjögren's Syndrome
• 18 years or older

Exclusion Criteria

• Patients with Secondary Sjögren's Syndrome,
• Patients who are diagnosed with other uncontrolled/clinically important diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
• Having a malignant condition,
• Pregnant individuals in the third trimester,
• Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role: lead

Responsible Party

Nazli Elif Nacar

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nazli Elif Nacar

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Kahramanmaras.SU

Identifier Type: -

Identifier Source: org_study_id