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临床试验/CTRI/2023/10/058819
CTRI/2023/10/058819尚未招募不适用

Acceptability and feasibility of Menstrual Cup among married women of reproductive age: a quasi-experimental study

未提供1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年10月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Feasibility and Acceptability of using menstrual cup among married reproductive age women..

研究概览

简要总结

Introduction- Menstrual Cup is a cost-effective ecofriendly convenient method of menstrual hygiene management but there is limited evidence of feasibility and acceptability of menstrual cups in India.

Objective- To study the acceptability and safety of menstrual cup among married women aged 18-49 years in rural block of India.

Method- It is a three phase Pre and Post Intervention study in a rural block of north India. During Phase I baseline assessment will be done to study the background information, current practices of a menstrual management, expenditure on menstrual products and attitude towards using menstrual cups. In phase II in person training on menstrual cup will be provided by the study team and the content of the training will be anatomy of the reproductive tract composition of cup, methods of insertion removal and cleaning of the cup. After the training the appropriate size menstrual cup will be provided to the participants. Phase III includes the feasibility and acceptability of menstrual cup at one three and six months and one year post introduction of the menstrual cup. Pilot tested semi structured questionnaire will be used to assess the quantitative data for data collection. Chi square test/ Fischer test, independent samples student t- tests and Mann Whitney tests will be used for analysis of quantitative data using SPSS 21. An IDI/FGD Guide will be developed to capture the qualitative data. Thematic analysis will be done to analyze the quaIitative data using ATLAS.ti. 8 software.

Discussion- The findings from this study will help in assessing the facilitators and barriers about menstrual cups. These results can be used to plan a large multi centric study with a larger sample size in the future to assess the feasibility and acceptability of the menstrual cup.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 49.00 Year(s)(—)
性别
Female

入选标准

  • 1.Women who are non-pregnant 2.who do not have gynaecological issue (cervicitis, vaginitis, prolapse etc.) 3.Who are currently using menstrual products other than menstrual cups.

排除标准

  • 1.Women with a history suggestive of intellectual disability will be excluded 2.Females in the reproductive age group (18-49 years) who have not attained menarche 3.Females in the reproductive age group (18-49 years) who have menopause due to physiological/surgical reasons 4.Did not give consent to participate in the study.

结局指标

主要结局

Feasibility and Acceptability of using menstrual cup among married reproductive age women..

时间窗: At the end of 1 month, 3 month, 6 month and 1 year after introduction of menstrual cups

次要结局

  • development of context specific awareness material on menstrual cup usage(At the time of training in Phase II & revision if required at the end of 1 year after introduction of menstrual cup)

研究者

发起方
未提供

研究点 (1)

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