Menstrual health interventions, schooling, and mental health problems among Ugandan students (MENISCUS): study protocol for a school-based cluster-randomised trial.
Menstrual health interventions, schooling, and mental health problems among Ugandan students (MENISCUS): study protocol for a school-based cluster-randomised trial.
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月经健康是一个越来越被认可的公共卫生问题，定义为与月经周期有关的完整的身体，精神和社会福祉。MENISCUS试验旨在评估针对月经健康的身体和情感方面的多组分干预是否可以改善乌干达中学女孩的教育程度，心理健康问题，月经管理，自我效能和生活质量。该研究是一项平行臂集群随机对照试验，在Wakiso和Kalungu地区的60所学校（集群）中进行，采用混合方法过程评估，以评估干预的保真度和可接受性以及经济和政策分析。这些学校将按1：1的比例随机分配到立即干预或优化常规护理，延迟干预交付。干预措施包括在学校设立月经保健行动小组，由非政府组织牵头对青春期教育培训员进行培训，编写戏剧短剧，提供月经保健包，包括可重复使用的护垫和月经杯，提供包括止痛药在内的疼痛管理战略，以及基本改善学校供水、环境卫生和个人卫生设施。基线数据将于2022年从中二学生中收集（中位年龄约15.5岁），干预实施1年后结束（约3600名女性和约900名男性的随机样本）。在女孩中评估的主要结果是：（一）基于干预措施实施期间教授的数学、英语和生物课程的考试成绩（由乌干达国家考试委员会独立评估）;（二）使用优势和困难25项问卷的总困难量表的心理健康问题。次要结果是女孩和男孩的月经知识和态度，以及仅女孩的月经实践、月经管理的自我效能、生活质量和幸福感、泌尿生殖系统感染的患病率、使用自我完成的月经日记的上学和上课情况以及对数学和科学的信心。该试验是创新的，在评估一个多组成部分的学校为基础的月经健康干预解决生理和情绪方面的月经健康，并使用“培训员培训”的模式，旨在学校内可持续发展。如果发现这种干预措施具有成本效益并可被接受，则有可能在国家和区域两级推广。ISRCTN 45461276。于2021年9月16日注册在线版本包含补充材料，可在10.1186/s13063-022-06672-4获得。
Menstrual health is an increasingly recognised public health issue, defined as complete physical, mental, and social well-being in relation to the menstrual cycle. The MENISCUS trial aims to assess whether a multi-component intervention addressing physical and emotional aspects of menstrual health improves educational attainment, mental health problems, menstrual management, self-efficacy, and quality of life among girls in secondary school in Uganda. The study is a parallel-arm cluster-randomised controlled trial with 60 schools (clusters) in Wakiso and Kalungu districts, with a mixed-methods process evaluation to assess intervention fidelity and acceptability and economic and policy analyses. The schools will be randomised 1:1 to immediate intervention or to optimised usual care with delayed intervention delivery. The intervention includes creation of a Menstrual Health Action Group at schools and NGO-led training of trainers on puberty education, development of a drama skit, delivery of a menstrual health kit including reusable pads and menstrual cups, access to pain management strategies including analgesics, and basic improvements to school water, sanitation, and hygiene facilities. Baseline data will be collected from secondary 2 students in 2022 (median age ~15.5 years), with endline after 1 year of intervention delivery (~3600 females and a random sample of ~900 males). The primary outcomes assessed in girls are (i) examination performance based on the Mathematics, English, and Biology curriculum taught during the intervention delivery (independently assessed by the Uganda National Examinations Board) and (ii) mental health problems using the Total Difficulties Scale of the Strengths and Difficulties 25-item questionnaire. Secondary outcomes are menstrual knowledge and attitudes in girls and boys and, in girls only, menstrual practices, self-efficacy in managing menstruation, quality of life and happiness, prevalence of urogenital infections, school and class attendance using a self-completed menstrual daily diary, and confidence in maths and science. The trial is innovative in evaluating a multi-component school-based menstrual health intervention addressing both physical and emotional aspects of menstrual health and using a “training of trainers” model designed to be sustainable within schools. If found to be cost-effective and acceptable, the intervention will have the potential for national and regional scale-up. ISRCTN 45461276. Registered on 16 September 2021 The online version contains supplementary material available at 10.1186/s13063-022-06672-4.
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