Clinical trial NCT05913648: Urdu Version of Menopause-specific Quality of Life Scale
Official title: Urdu Translation, Validity and Reliability of Menopause-specific Quality of Life Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 290
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women after menopause will be recruited to report their quality of life domains on the translated version of MENQOL scale

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.

Detailed description: Menopause is accompanied by a variety of physiological changes and symptoms, including hot flashes, nightly sweating, anxiety, headaches, vaginal dryness, lethargy, irritability, and sleep disturbance. Menopause and its symptoms frequently have an impact on postmenopausal women's quality of life, a metric that is influenced by a variety of societal and personal circumstances. The Menopause-Specific Quality of Life Questionnaire(MENQOL) evaluates the prevalence and severity of bothersome physical and psychological concerns that women could experience during the menopausal transition.

As cross-border and cross-cultural studies continue to increase, there is a greater need for linguistic validation of tools in various societies. Until now no translation or adaptation of the MENQOL questionnaire has been made for the population with different languages in Pakistan. There is a need for culturally adapted screening tools to aid healthcare professionals or clinicians to screen the symptoms of menopausal women in the Pakistani population. As the Urdu language is Pakistan's national language so commonly used all over Pakistan, so it is required to translate and culturally adapt the MENQOL scale into Urdu language for the Pakistani population.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Menopause-specific quality of life (MENQOL)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Ghosia medical center
Study officials:
affiliation: Riphah International University
name: Huma Riaz, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.