Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058883) titled 'Evaluation Study on the Effectiveness of Online Consultation Tools for Menopausal Symptoms in Working Women' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Ochanomizu University

Condition: Condition - menopausal disorder Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to verify whether an online consultation tool, primarily based on LINE chat consultations, is effective in alleviating menopausal symptoms and improving work productivity for working women who suspect they have menopausal symptoms. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention group: Receive free access to an online learning tool and a chat consultation service provided via LINE by TRULY Inc.. This service is operated under the supervision of medical professionals. Through the LINE platform, participants can directly access educational content and chat consultations on women's health issues, primarily menopausal symptoms. Responses to these consultations will be provided by doctors, nurses, and public health nurses who have contracts with TRULY Inc., ensuring that all advice is based on reliable medical knowledge. Interventions/Control_2 - Control group: no intervention will be provided during the study period. After the study ends, participants in the control group will be given free access to the same online learning tool and chat consultation service via LINE, provided by TRULY Inc. for six months, as offered to the intervention group.

Eligibility: Age-lower limit - 45 years-old = Gender - Female Key inclusion criteria - 1) Must possess a LINE account and use it regularly. 2) Female, aged between 45 and 55 years old (inclusive). 3) Must be currently employed (regardless of employment type). 4) Must have experienced irregular menstruation or amenorrhea (absence of menstruation) for at least 12 consecutive months within the past 12 months. 5) Must be aware of at least mild menopausal symptoms (a score of 26 or higher on the Simplified Menopausal Index [SMI]). 6) Must be able to use the internet via a smartphone, tablet, or computer. 7) Must be able to understand explanations provided in Japanese and be judged capable of giving informed consent online voluntarily. Key exclusion criteria - 1) Currently be receiving treatment for menopausal symptoms (e.g., hormone replacement therapy, herbal medicine). 2) Currently be receiving treatment for gynecological diseases. 3) Currently be receiving treatment for mental health disorders. Target Size - 500

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2024 Year 11 Month 12 Day Date of IRB - 2024 Year 11 Month 12 Day Anticipated trial start date - 2025 Year 09 Month 12 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067280

Disclaimer: Curated by HT Syndication.