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

Introduction: Menopause is characterised by the ending of the menstrual cycle as part of a natural process. However, menopause can also be caused due to other health conditions such as premature ovarian failure or cancers that may have led to a oophorectomy or a radical hysterectomy. The physiological and psychological mechanisms linked to menopause across all age groups, races and ethnicities is not well understood. The paucity of data could reduce advancement of optimal clinical practice leading to reduce quality of life for women. To better explore and assess menopause we have designed the Menopause Mental Health Rating (MARiE) tool.

Methods: We will conduct a prospective mixed methods study in women and trans-men≥18 years old that are experiencing perimenopause, menopause or post-menopause. The development phase of the MARiE tool will involved a systematic review and in depth exploration of the range of symptoms experienced during menopause as part of a co-production workshop with thirty women. This was used to design the quantitative questionnaire, MARiE tool and the qualitative topic guides. This will include the 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. The MARiE tool will be clinically reviewed for face validity and completed by thirty women with confirmed menopause.

Ethics Approval: Research Ethics approval reference for this study in the UK is 22/EE/0159. Country specific approvals, as required have been obtained. Any additional countries that may take-part in the project after this article has been published will be included in the main manuscript.

Dissemination: The study findings will be made available using a peer review publication journal, workshops and conferences.