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Completed

NCT Number: NCT05010551

Translation and Validation of MPCOSQ in Urdu Language

To translate and validate modifies polycystic ovary syndrome quality of life (MPCOQ) questionnaire into Urdu. To evaluate the reliability, validity and of Urdu version of modified polycystic ovary syndrome quality of life questionnaire (MPCOQ).

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Key information

Age range

18 year–30 year

Sex eligibility

Female

Study type

Observational

Primary location

Abeer Fatima, Islamabad, Punjab Province, Pakistan

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About this study

  • All statistical analyses will be conducted using the Statistical Product and Service Solution version 21 software.
  • Continuous variables will be shown by mean and standard deviation and the categories will be demonstrated in frequency and percentage.
  • In this study, factor structure of the (MPCOQ) will be analyzed using the principal component factor analysis with varimax rotation.
  • Intraclass Correlation Coefficient (ICC) (95% confidence interval) will be used for test-retest value and Cronbach's Alpha will be used for internal consistency analysis.
  • Measurement error will be determined by calculating the standard error of measurement (SEM) and the Smallest Detectable Change (SDC). Independent t-test will be used to determine the differences between groups

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Age 18 - 30
  • Married
  • Female patients diagnosed with PCOS, having 2 of the following Rotterdam diagnostic criteria:

I. Polycystic ovaries visualized on ultrasound scan (presence of 12 follicles or more in one or both ovaries and/or increased ovarian volume >10ml II. Clinical signs of hyperandrogenism (the hirsutism score based on the Ferriman-Gallwey score >7 or obvious acne) III. Having an interval between menstrual periods >35 days and/or amenorrhea as the absence of vaginal bleeding for at least 6 months, i.e. 199 days Patients who are willing to participate

Exclusion criteria

  • • Non-adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia
  • Female undergoing Hormone Replacement Therapy
  • Female with malignancies
  • Any recent fractures, surgeries
  • Patient with nephrological and neurological conditions
  • Dementia or cognitive impairments

Treatment and study plan

Primary outcomes

  1. Modified polycystic ovary syndrome quality of life questionnaire

    Time frame: 6 months

    The tool is to measure health related quality of life of females suffering from PCOS. it contains 30 items with 6 main areas related to hirsutism , acne, weight, infertility, emotional disturbance, menstrual difficulties to define different symptoms of PCOS. then quality of life will be measured of respective patients. The total is 210 with higher score indicating a better quality of life.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Translation and Validation of Modified Polycystic Ovary Syndrome Questionnaire in Urdu Language

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 18, 2021
Registry last updated
Apr 28, 2022

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

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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.

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