MenopauseNCT05913648
Urdu Version of Menopause-specific Quality of Life Scale
An observational study of Menopause, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Tool Translation
- How many people
- 290 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women after menopause will be recruited to report their quality of life domains on the translated version of MENQOL scale
Who may be able to join
- Natural Menopause
- Females who are able to speak and read Urdu
- Volunteer to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urdu Translation, Validity and Reliability of Menopause-specific Quality of Life Scale
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.
Read the 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.
- Conditions
- Menopause
- Being tested
- Tool Translation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tool TranslationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start15 Jul 2023
- Primary completion30 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913648
- Sponsor's protocol ID
- RiphahIU Khansa Ishaq
- Status last verified
- Mar 2024
- First submitted
- 12 Jun 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36276615Rathnayake 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.
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.
PubMed 32217885Hilditch 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.
PubMed 8844630
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urdu Translation, Validity and Reliability of Menopause-specific Quality of Life Scale
- ClinicalTrials.gov ID
- NCT05913648
- Acronym / sponsor ID
- RiphahIU Khansa Ishaq
- Conditions
- Menopause
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women after menopause will be recruited to report their quality of life domains on the translated version of MENQOL scale
Key inclusion criteria (3 listed)
- Natural Menopause
- Females who are able to speak and read Urdu
- Volunteer to participate in the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tool TranslationThe 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. | Other | – |
Primary outcome
Menopause-specific quality of life (MENQOL)
Time frame: Baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 36276615Beura 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.
- BackgroundRathnayake 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: PubMed 32217885Papadima 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.
- Background: PubMed 8844630Hilditch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huma Riaz, PHD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause-specific quality of life (MENQOL) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05913648, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.