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临床试验/NCT07248436
NCT07248436已完成不适用

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

Pamukkale University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)

研究概览

简要总结

The aim of this study is to examine the Turkish validity and reliability of the Pelvic Floor Distress Inventory-20 in patients with pSS.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Begüm AKAR

Principal investigator

Pamukkale University

研究点 (1)

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