Clinical trial NCT06410742: The Role of Central Sensitization on Biopsychosocial Factors in Primary Sjögren's Syndrome
Official title: Exploring the Role of Central Sensitization on Biopsychosocial Factors in Primary Sjögren's Syndrome: a Cross-Sectional Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sjogren's Syndrome
Keywords: Sjogren' Syndrome
correlation
xerostomia
dryness
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals diagnosed with primary Sjögren's Syndrome according to the American European Consensus Criteria in Hacettepe University, Faculty of Medicine, Rheumatology Department, and volunteers to participate in the study will recruit this study.

The total number of individuals to be included in the study will be calculated with 80% power and 95% confidence interval with the data obtained after the pilot study.

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


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.

Primary outcomes:
measure: BETY-Biopsychosocial Questionnaire (BETY-BQ)
timeFrame: baseline
measure: Turkish Eating Assessment Tool
timeFrame: baseline
measure: Xerostomia inventory
timeFrame: baseline
measure: Multidimensional Fatigue Rating Scale
timeFrame: baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline
measure: Test of Mastication and Swallowing Solids
timeFrame: baseline
measure: Dysphagia limit
timeFrame: baseline
Secondary outcomes:
measure: Central Sensitization Scale
timeFrame: baseline
measure: Pain Catastrophizing Scale
timeFrame: baseline
measure: EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
timeFrame: baseline
measure: EULAR Sjögren's Syndrome Patient Reporting Index (ESSPRI)
timeFrame: baseline
measure: Primary Sjögren's Syndrome Quality of Life Scale
timeFrame: baseline
measure: Yale Swallow Protocol
timeFrame: baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Nazli Elif Nacar
Study officials:
References: