NCT05913648

Brief Summary

Menopause is accompanied by a spectrum of symptoms that are frequently related to hormonal changes. Menopause and its symptoms frequently have an impact on postmenopausal women's Quality of Life. There is a need for culturally adapted screening tool to aid healthcare professionals or clinicians to screen the symptoms of menopausal women, so the aim of this study is to translate the Menopause specific quality of life (MENQOL) into Urdu and to find the reliability and validity of the translated version Menopause specific quality of life in menopausal women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

June 12, 2023

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Menopause-specific quality of life (MENQOL)

    The Menopause-Specific Quality of Life (MENQOL) questionnaire is a tool designed to assess the quality of life of women who are experiencing menopause. It consists of 29 items that measure the impact of menopausal symptoms on four domains: vasomotor (item 1-3). Psychological (items 4-10), physical (items 11-26) and sexual (items 27-29). The higher score indicates the symptom is more bothersome whereas the lower score indicates the symptoms are not at all bothered.

    Baseline

Interventions

The Data Collection procedure will be done in two phases. The first phase will revolve around the translation of the instrument. Firstly the tool will be translated into Urdu with the help of two professional translators and then it will be back-translated into English to cross-check the clarity of the text. The translation will focus more on the context and understanding of the text rather than literal word-to-word meanings. The translation will be done according to the WHO guidelines. The Urdu version of MENQOL will be used to assess content validity on menopausal women.

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women after menopause will be recruited to report their quality of life domains on the translated version of MENQOL scale

You may qualify if:

  • Natural Menopause
  • Females who are able to speak and read Urdu
  • Volunteer to participate in the study

You may not qualify if:

  • Mental in capacity to complete a self-administered questionnaire
  • Communication problem
  • Taking treatment for menopausal symptoms
  • History of hysterectomy or ovariectomy
  • Any systemic Chronic diseases affecting quality of life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghosia medical center

Rawalpindi, 46000, Pakistan

Location

Related Publications (4)

  • Beura S, Patnaik L, Sahu M. Translation, Reliability, and Validity Test of Odia Version of Menopause-Specific Quality of Life Questionnaire Among Postmenopausal Women for Menopausal Symptoms. J Midlife Health. 2022 Apr-Jun;13(2):121-126. doi: 10.4103/jmh.jmh_222_21. Epub 2022 Sep 16.

    PMID: 36276615BACKGROUND
  • Rathnayake N, Alwis G, Lenora J, Mampitiya I, Lekamwasam S. Linguistic and psychometric validation of sinhala version of menopause specific quality of life questionnaire. Sri Lanka J Soc Sci. 2021;44(1):15-26.

    BACKGROUND
  • Papadima EI, Boutsiadis A, Soldatou A, Ivanidou S, Vassilakou T, Michala L. Linguistic translation and validation of the Menopause-specific Quality of Life (MENQOL) questionnaire in Greek menopausal women. Menopause. 2020 Jul;27(7):808-815. doi: 10.1097/GME.0000000000001527.

    PMID: 32217885BACKGROUND
  • Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8.

    PMID: 8844630BACKGROUND

Study Officials

  • Huma Riaz, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2023

First Posted

June 22, 2023

Study Start

July 15, 2023

Primary Completion

October 30, 2023

Study Completion

December 31, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations