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

Sjogren's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06410742
• Other study ID #: Kahramanmaras.SU
• Status: Recruiting
• Start date: June 19, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome

Locations

Country	Name	City	State
Turkey	Nazli Elif Nacar	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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