An Exploration of the Mental Health impact among Menopausal Women: The MARIE Project Protocol (International Arm)

Abstract

Menopause is characterised by the ending of the menstrual cycle as part of a natural process. However, menopause can also be caused by other health conditions, such as premature ovarian failure or cancers that may have led to an oophorectomy or a radical hysterectomy. The physiological and psychological mechanisms linked to menopause across all age groups, races and ethnicities are not well understood. The paucity of data could reduce the advancement of optimal clinical practice, leading to reduced quality of life for women. To better explore and assess menopause, we have designed the MenopAuse mental hEalth Rating (MARiE) tool. We will conduct a prospective mixed methods study using two work streams of WP2a and WP2b among in women 18 years and above that are experiencing perimenopause, menopause or post-menopause among an array of ethnicities and races. WP2a will involve a number of validated clinical assessments of Hospital Anxiety and Depression Scale, Insomnia Severity Index Scale, Menopause Rating Scale, Greene Climacteric Scale, Health Related Quality of Life, Quebec Pain Disability Scale, and Burnout Assessment Tool will be administered digitally using the Qualtrex platform. WP2b will assess the feasibility of using a novel tool called MARiE to report face validity and efficacy. Research Ethics approval reference for this study in the UK is 22/EE/0159. As required, country-specific approvals have been obtained and continue to be secured. The study findings will be made available using a peer review publication journal, workshops and conferences.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

Not applicable

Funding Statement

This study did not receive any funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics committee of participating organisations gave ethical approval for this work

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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