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

NCT07248436 | Completed

• 1 other identifier: Pamukkale U
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjogren Syndrome

Keywords

Sjogren syndrome

Outcome Measures

Primary Outcomes (3)

• 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.

  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".

  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.

  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)

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

• Health assessment questionnaire (HAQ)

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Study Arms (1)

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.

Other: the validity and reliability study

Interventions

the validity and reliability study OTHER

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

Sjogren syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sjogren syndrome group

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale Üniversitesi

Pamukkale, Denizli, 20000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: March 28, 2025
• Primary Completion: May 28, 2025
• Study Completion: July 28, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)