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Validity and Reliability of Pelvic Floor Distress Inventory-20 in Primary Sjögren's Syndrome

Investigation of the Validity and Reliability of the Pelvic Floor Distress Inventory-20 in Individuals With Primary Sjögren's Syndrome.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07248436
Enrollment
10
Registered
2025-11-25
Start date
2025-03-28
Completion date
2025-07-28
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren Syndrome

Keywords

Sjogren syndrome

Brief 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.

Interventions

OTHERthe validity and reliability study

To obtain the validity and reliability of the questionnaire in individuals with Sjögren's syndrome.

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)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)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)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.

Secondary

MeasureTime frameDescription
Cognitive Exercise Therapy Approach (BETY)Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.This scale has 30 items. The scale is scored with a 5-point Likert system.
Health assessment questionnaire (HAQ)Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.This questionnaire consists of 20 questions and 8 subheadings, each answer ranging from 0 to 3 points.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026