Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062407) titled 'Effectiveness of a Multi-level Organizational Support and Comprehensive Initiatives for Menstrual Health and Workplace Well-being among Women Workers in Japan' on Aug. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - The University of Tokyo
Condition:
Condition - Menstrual-related symptoms and menopausal symptoms
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To develop and evaluate a multicomponent workplace intervention combining organizational-level intervention, supervisor training, and individual training for female employees, and to examine its effects on menstrual-related symptoms and work productivity among female workers.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Organizational-level workplace initiatives. Company representatives select and implement measures from a list of workplace initiatives tailored to their organization's circumstances. Research collaborators provide periodic progress checks and advice.
Individual training for female employees. A training session aimed at improving health literacy regarding female-specific health issues and promoting mental health care.
Training for supervisors and managers. Covers management skills for supporting subordinates' work-life balance, knowledge of female-specific health issues, communication methods, workload optimization, and line care for mental health.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Female workers: (1) employed at a company participating in this study; (2) aged 18 years or older; (3) received an explanation of the study and provided consent to participate.
Supervisors/managers (male and female): (1) employed at a company participating in this study; (2) aged 18 years or older; (3) received an explanation of the study and provided consent to participate.
Key exclusion criteria - NONE
Target Size - 1100
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 07 Month 24 Day
Date of IRB - 2026 Year 07 Month 27 Day
Anticipated trial start date - 2026 Year 08 Month 01 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071409
Disclaimer: Curated by HT Syndication.