跳至主要内容
临床试验/CTRI/2025/08/093676
CTRI/2025/08/093676尚未招募不适用

Cross-cultural adaptation, translation and psychometric evaluation of the Hindi version of Pelvic Floor Distress Inventory-Short Form 20 in Indian Women

Galgotias University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Pelvic Floor Distress Inventory-Short Form 20

研究概览

简要总结

Pelvic floor disorders (PFDs), including urinary incontinence and pelvic organ prolapse, significantly impact women’s quality of life. The Pelvic Floor Distress Inventory–Short Form 20 (PFDI-SF 20) is a validated patient-reported outcome measure internationally, but no Hindi version exists. This study aims to translate, culturally adapt, and evaluate the psychometric properties of the Hindi PFDI-SF 20 for use in Indian women. A cross-sectional design will be used, recruiting adult women with pelvic floor symptoms who understand Hindi. Translation will follow standard forward-backward methods and expert committee review. Reliability (internal consistency and test-retest) and validity (content and construct) will be assessed. The study will provide a reliable and culturally relevant Hindi tool for assessing pelvic floor distress, enabling better clinical evaluation, monitoring, and research in Indian women. Ethical approval and informed consent will be obtained.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • Women diagnosed with pelvic floor disorders Native Hindi speakers Able and willing to provide informed consent.

排除标准

  • Presence of neurological or psychiatric disorders Pregnancy or postpartum within 6 weeks Illiteracy or inability to comprehend the questionnaire Acute infections or recent pelvic surgeries of more than three months.

结局指标

主要结局

Pelvic Floor Distress Inventory-Short Form 20

时间窗: At baseline and after 48 hours

次要结局

未报告次要终点

研究者

发起方
Galgotias University
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Jyoti Sharma

Galgotias University

研究点 (1)

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