Skip to main content
OpenTrials
Completed

NCT Number: NCT07248436

"Validity and Reliability of Pelvic Floor Distress Inventory-20 in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Pamukkale Üniversitesi

Pamukkale, Denizli, 20000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the validity and reliability study

Other

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

Primary outcomes

  1. 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.

  2. 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".

  3. 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.

Secondary outcomes

  1. 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.

    This scale has 30 items. The scale is scored with a 5-point Likert system.

  2. 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.

    This questionnaire consists of 20 questions and 8 subheadings, each answer ranging from 0 to 3 points.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.