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Clinical Trials/CTRI/2024/04/065056
CTRI/2024/04/065056Not yet recruitingNot Applicable

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 site in 1 country126 target enrollmentStarted: April 15, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
126
Locations
1
Primary Endpoint
Validation of the translated questionnaire

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
19.00 Year(s) to 55.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Validation of the translated questionnaire

Time Frame: 3 months,1 year

Secondary Outcomes

  • 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)

Investigators

Sponsor
Shri B M Patil Medical College,Hospital & RC
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Preeti Shankar Malapure

Shri B M Patil Medical College, Hospital and Research Centre

Study Sites (1)

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