Sjogren's SyndromeNCT06410742
Comprehensive Evaluation of Clinical and Biopsychosocial Characteristics in Primary Sjögren's Disease
An observational study of Sjogren's Syndrome, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sjogren's Syndrome
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2024to 1 Jan 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with Primary Sjögren's Syndrome
- 18 years or older
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Keywords
- Sjogren' Syndrome, correlation, xerostomia, dryness
- Medical subject headings
- Sjogren's Syndrome, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with primer Sjogren's syndrome | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start19 Jun 2024
- Primary completion30 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazli Elif Nacar, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410742
- Sponsor's protocol ID
- Kahramanmaras.SU
- Status last verified
- Dec 2024
- First submitted
- 6 May 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Evaluation of Clinical and Biopsychosocial Characteristics in Primary Sjögren's Disease
- ClinicalTrials.gov ID
- NCT06410742
- Acronym / sponsor ID
- Kahramanmaras.SU
- Conditions
- Sjogren's Syndrome
- Keywords
- Sjogren' Syndrome, correlation, xerostomia, dryness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with primer Sjogren's syndrome | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients diagnosed with Primary Sjögren's Syndrome
- 18 years or older
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BETY-Biopsychosocial Questionnaire (BETY-BQ)
Time frame: baseline
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.
Turkish Eating Assessment Tool
Time frame: baseline
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.
Xerostomia inventory
Time frame: baseline
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.
Multidimensional Fatigue Rating Scale
Time frame: baseline
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).
Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline
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.
Test of Mastication and Swallowing Solids
Time frame: baseline
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.
Dysphagia limit
Time frame: baseline
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.
6 secondary outcomes
Central Sensitization Scale
Time frame: baseline
Pain Catastrophizing Scale
Time frame: baseline
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
Time frame: baseline
EULAR Sjögren's Syndrome Patient Reporting Index (ESSPRI)
Time frame: baseline
Primary Sjögren's Syndrome Quality of Life Scale
Time frame: baseline
Yale Swallow Protocol
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjogren's Syndrome, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BETY-Biopsychosocial Questionnaire (BETY-BQ) (time frame: baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.