Evaluation of Biopsychosocial Features, Pain, Fatigue, Quality of Life, Swallowing, and Disease-Specific Symptoms in Patients With Primer Sjogren's Syndrome

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sjogren's Syndrome

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Turkey
  • Kahramanmaraş, Turkey, 46000
    • Nazli Elif Nacar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

In the control, the evaluation group without any diagnosis and the patient's relatives, academic administrative personnel similar in age groups will constitute healthy individuals who volunteer to participate.

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with primer Sjogren's syndrome
Healthy individual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BETY-Biopsychosocial Questionnaire (BETY-BQ)	BETY-BQ consists of the following six subtitles that investigate in detail the biopsychosocial dimensions: pain, functionality and fatigue, mood, sociability, sexuality, and sleep quality. This scale consists of 30 items, scored on a 5-point Likert system. Each question is scored as "No never: 0 Yes rarely: 1 Yes sometimes: 2 Yes often: 3 Yes always: 4" and a total score over 30 items. A higher score indicates a poorer biopsychosocial situation.	baseline
Turkish Eating Assessment Tool	Turkish Eating Assessment Tool is a survey consisting of 10 questions with a Likert scale between 0 and 4 (0 = no problem, 4 = severe problem). The total score is calculated out of 40 points by finding the sum of the answers given by individuals to each question. A score of 3 or more in the survey is considered abnormal. A score of 16 or above is considered as suspicion of aspiration.	baseline
Xerostomia inventory	The scale consists of 11 items. Patients will be asked to choose the best response for each item describing their symptoms over the previous two weeks. Responses are scored from 1 to 5 (1: never, 2: rarely, 3: occasionally, 4: fairly often, and 5: very often). The sum of the item scores gives a total score ranging from 11 to 55, and a higher score indicates that the symptoms are more severe.	baseline
Multidimensional Fatigue Rating Scale	This scale evaluates fatigue with 16 items under 5 subheadings: degree, severity, impact on daily activities, troubles it causes, and fatigue time. The score ranges from 0 (not tired) to 50 (extremely tired).	baseline
Hospital Anxiety and Depression Scale (HADS)	In this scale consisting of fourteen questions, odd-numbered questions questioning anxiety, and even questions question depression. Options range from 0 to 3, with a higher score indicating a poor emotional state. The cut-off values of the scale were determined as 10 for the anxiety subscale and 7 for the depression subscale.	baseline
Test of Mastication and Swallowing Solids	In our study, the Test of Masticating and Swallowing Solids (TOMASS) will be used. The test evaluates how many bites the individual takes to eat a biscuit while sitting upright, how many chewing cycles he makes, how many times he swallows it, and how long the total time is from biting to swallowing. Video recording will be taken during the test. The number of bites, number of chewing cycles, number of swallows and total time will be calculated on the video.	baseline
Dysphagia limit	While evaluating dysphagia, individuals are given 5, 10, 15, 20, 25, 30, 35, 40 and 45 mL volumes of liquid, respectively, with a graduated syringe and are asked to swallow the liquid. The maximum amount of fluid that the thyroid cartilage can swallow during a single movement is determined. The normal dysphagia limit in healthy individuals is more than 20 mL. If a person can swallow 20 mL normally, the dysphagia limit is normal.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Sensitization Scale	In this scale, which consists of 40 questions and questions the symptoms related to central sensitization, a score above 40 is interpreted as an indicator of central sensitization.	baseline
Pain Catastrophizing Scale	It is a Likert-type self-assessment scale consisting of 13 items. Each item is scored between 0 and 4 points. The total score ranges from 0 to 52. High scores indicate a high level of catastrophizing. It has 3 subtests: pain magnification (items 6, 7 and 13), rumination (items 8, 9, 10, 11) and helplessness (items 1, 2, 3, 4, 5 and 12).	baseline
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)	ESSDAI is a clinical scale that measures disease activity in Sjögren's Syndrome and its items provide objective data consisting of tests applied to patients during routine outpatient clinic check-ups. An ESSDAI score of less than 4 indicates low activity, a score between 5 and 13 indicates moderate activation, and a score of 14 and above indicates high activity.	baseline
EULAR Sjögren's Syndrome Patient Reporting Index (ESSPRI)	ESSPRI scoring is a symptom severity assessment scale filled out by the patient and used in Sjögren's Syndrome. The patient is asked to express fatigue, pain and dryness complaints with a score between one and ten, and the arithmetic average of the score obtained from these three questions forms the result. An ESSPRI score of less than 5 is considered an acceptable disease state, while a score of 5 or above is considered a sign of high activity.	baseline
Primary Sjögren's Syndrome Quality of Life Scale	This scale, consisting of twenty-five questions, is divided into two subsections: physical (discomfort and dryness) and psychosocial. Since vaginal dryness, one of the symptoms of SS, was included in the total score, the maximum score was determined as 96 for women and 92 for men. A high score means low health-related quality of life.	baseline
Yale Swallow Protocol	Protocol has 3 main components: exclusion criteria, short cognitive test and oral mechanism, and drinking 90cc water directly from the glass. Patients who complete step 1 and are not contraindicated for testing proceed to short cognitive testing phase. Patients who pass the short cognitive test and oral mechanism stages can move on to 3th stage, which is drinking 90 cc of water. 90 cc water swallow challenge protocol is a simple assessment that can be used by many qualified healthcare professionals to identify aspiration risk because it is easy to perform, highly reliable, cost-effective, and clinically validated. During test, patient is asked to drink 90 cc of water in consecutive swallows, slowly and continuously but without stopping. Patient is evaluated for signs of i.stopping drinking while drinking, ii.coughing/choking during or immediately after drinking. Patients showing these findings are recorded as 'failing' test.	baseline

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2024
• Primary Completion (Estimated): October 15, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: xerostomia; correlation; dryness; Sjogren' Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: Kahramanmaras.SU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No