Translation and Validation of MPCOSQ in Urdu Language

April 21, 2022 updated by: Riphah International University

Translation and Validation of Modified Polycystic Ovary Syndrome Questionnaire 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).

Study Overview

Status

Completed

Conditions

Detailed Description

  • 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

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Rawalpindi, Pakistan
        • Zohra Institute of Health Sciences
    • Punjab
      • Islamabad, Punjab, Pakistan, 45000
        • Abeer Fatima

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients diagnosed with PCOS

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Sarah Ehsan, Riphah International University
  • Principal Investigator: Abeer Fatima, MS(cppt), Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2020

Primary Completion (Actual)

May 30, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/00843 Rabbiya Zaman

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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