跳至主要内容
临床试验/CTRI/2024/04/065056
CTRI/2024/04/065056尚未招募不适用

Adaptation and Translation of the Australian Pelvic Floor Questionnaire for Pregnant and Postpartum Kannada-Speaking Women in India: A Cross-Cultural Validation Study

Shri B M Patil Medical College,Hospital & RC1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年4月15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
126
试验地点
1
主要终点
Validation of the translated questionnaire

研究概览

简要总结

Many women face the challenges of pelvic floor dysfunction, which manifest through symptoms such as urinary incontinence, urinary tract infections, fecal incontinence, flatulence, sexual problems, and pelvic organ prolapse. It’s noteworthy that pelvic floor dysfunction affects up to 25% of all women. These issues often emerge or worsen during and after pregnancy, burdening young women with silent struggles. Due to the stigma and cultural barriers surrounding these topics, they often refrain from seeking treatment. Early identification and management of these disorders are critical to prevent potential long-term complications.

The Australian pelvic floor questionnaire (APFQ)is an interviewer-administered tool designed to comprehensively assess pelvic floor health, encompassing bladder, bowel, and sexual function, as well as pelvic organ prolapse, severity, bothersomeness, and condition-specific quality of life. It’s a well-validated instrument and has been successfully translated into a few languages, including Swedish, Polish, Brazilian, Sinhala, Chinese, among others. These translations have expanded the reach of this assessment tool to women worldwide, breaking down cultural barriers that surround pelvic floor problems.

However, in India, no such translations are available, and Kannada, being the predominant language in the Vijayapura district, presents an opportunity for cultural adaptation and validation. Thus, our aim is to translate the APFQ into Kannada, ensuring it is culturally acceptable to the local pregnant and postpartum population, thereby enabling early identification and management of pelvic floor disorders.

研究设计

研究类型
Observational

入排标准

年龄范围
19.00 Year(s) 至 55.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant women more than 19 years and more than 28 weeks period of gestation ,Post partum women upto 12 months of delivery and All participants should be fluent or literate in Kannada.

排除标准

  • 1.Urogenital malformations, or medications affecting bladder or bowel or sexual function .
  • 2.Women who don’t wish to be included in the study 3.Non Kannada speaking women 4.Patients with psychiatric disorder 5.Clinically unstable patients 6.Malignancy or fractures of the pelvic area, 7.Patients with no cognitive ability to answer the questionnaire.

结局指标

主要结局

Validation of the translated questionnaire

时间窗: 3 months,1 year

次要结局

  • To assess the content validity of the translated questionnaire by obtaining feedback from healthcare professionals, researchers, & pregnant & postpartum Kannada-speaking women.
  • To evaluate the psychometric properties of the adapted & translated questionnaire, including its reliability & validity, within the Kannada-speaking pregnant & pastpartum population.(20 weeks)

研究者

发起方
Shri B M Patil Medical College,Hospital & RC
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Preeti Shankar Malapure

Shri B M Patil Medical College, Hospital and Research Centre

研究点 (1)

Loading locations...

相似试验