Sjogren SyndromeNCT07248436
"Validity and Reliability of Pelvic Floor Distress Inventory-20 in Primary Sjögren's Syndrome"
An observational study of Sjogren Syndrome, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the Turkish validity and reliability of the Pelvic Floor Distress Inventory-20 in patients with pSS. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Sjogren Syndrome
- What is being tested?
- the validity and reliability study
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Mar 2025to 28 Jul 2025
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Sjogren syndrome group
Who may be able to join
- Being diagnosed with Primary Sjögren's Syndrome by the PAÜ Rheumatology clinic
- Being between the ages of 18 and 65
- Volunteering to participate in the study
Who cannot join
- Presence of neurological disease
- Presence of any orthopedic problem that may affect functionality
- History of orthopedic surgery
- Presence of psychiatric disorder that may affect cooperation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale Üniversitesi
Pamukkale, Denizli, 20000
About this study
Official title: "Investigation of the Validity and Reliability of the Pelvic Floor Distress Inventory-20 in Individuals With Primary Sjögren's Syndrome."
The aim of this study is to examine the Turkish validity and reliability of the Pelvic Floor Distress Inventory-20 in patients with pSS.
- Conditions
- Sjogren Syndrome
- Being tested
- the validity and reliability study
- Keywords
- Sjogren syndrome
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the validity and reliability studyOther
"To obtain the validity and reliability of the questionnaire in individuals with Sjögren's syndrome."
| Study group | Role | What they receive |
|---|---|---|
| Sjogren syndrome | The Sjogren syndrome group will consist of patients over the age of 18 who apply to the Rheumatology Department of Pamukkale University and meet the inclusion criteria. Receives: Other: the validity and reliability study |
What is being measured
The primary outcome is the main question the study is designed to answer.
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
The patient is asked to rate their complaints of fatigue, pain, and dryness on a scale from 1 to 10, and the arithmetic average of the scores obtained from these three questions is calculated. An ESSPRI score below 5 is considered an acceptable disease status, while a score of 5 or above is considered an indicator of high disease activity.
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Pelvic Floor Distress Inventory-20 (PTDE-20)
There are 20 questions in total on the scale. The best score that can be obtained from the entire survey is "0" and the worst score is "300".
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Visual Analog Scale (VAS)
VAS is used to convert certain values that cannot be measured numerically into numerical form. The patient is asked to indicate where their condition fits on this line by drawing a line, placing a dot, or marking a point. It is evaluated on a scale from 0 to 10.
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Secondary outcomes (2)
Cognitive Exercise Therapy Approach (BETY)
This scale has 30 items. The scale is scored with a 5-point Likert system.
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Health assessment questionnaire (HAQ)
This questionnaire consists of 20 questions and 8 subheadings, each answer ranging from 0 to 3 points.
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start28 Mar 2025
- Primary completion28 May 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren SyndromeStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begüm AKAR, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248436
- Sponsor's protocol ID
- Pamukkale U
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Investigation of the Validity and Reliability of the Pelvic Floor Distress Inventory-20 in Individuals With Primary Sjögren's Syndrome."
- ClinicalTrials.gov ID
- NCT07248436
- Acronym / sponsor ID
- Pamukkale U
- Conditions
- Sjogren Syndrome
- Keywords
- Sjogren syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 25 Nov 2025 (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.
The aim of this study is to examine the Turkish validity and reliability of the Pelvic Floor Distress Inventory-20 in patients with pSS.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sjogren syndrome | – | Other: the validity and reliability studyThe Sjogren syndrome group will consist of patients over the age of 18 who apply to the Rheumatology Department of Pamukkale University and meet the inclusion criteria. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sjogren syndrome group
Key inclusion criteria (3 listed)
- Being diagnosed with Primary Sjögren's Syndrome by the PAÜ Rheumatology clinic
- Being between the ages of 18 and 65
- Volunteering to participate in the study
Key exclusion criteria (4 listed)
- Presence of neurological disease
- Presence of any orthopedic problem that may affect functionality
- History of orthopedic surgery
- Presence of psychiatric disorder that may affect cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the validity and reliability study"To obtain the validity and reliability of the questionnaire in individuals with Sjögren's syndrome." | Other | Sjogren syndrome |
Primary outcome
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
The patient is asked to rate their complaints of fatigue, pain, and dryness on a scale from 1 to 10, and the arithmetic average of the scores obtained from these three questions is calculated. An ESSPRI score below 5 is considered an acceptable disease status, while a score of 5 or above is considered an indicator of high disease activity.
Pelvic Floor Distress Inventory-20 (PTDE-20)
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
There are 20 questions in total on the scale. The best score that can be obtained from the entire survey is "0" and the worst score is "300".
Visual Analog Scale (VAS)
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
VAS is used to convert certain values that cannot be measured numerically into numerical form. The patient is asked to indicate where their condition fits on this line by drawing a line, placing a dot, or marking a point. It is evaluated on a scale from 0 to 10.
2 secondary outcomes
Cognitive Exercise Therapy Approach (BETY)
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Health assessment questionnaire (HAQ)
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
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 25 Nov 2025.
- Individual participant dataSharing planned: No
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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 Syndrome, run by Pamukkale 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 3 inclusion and 4 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 25 Nov 2025. 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?
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) (time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.). The study lists 3 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 25 Nov 2025.