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临床试验/CTRI/2025/09/094542
CTRI/2025/09/094542尚未招募不适用

Menstrual hygiene practices and their effect on the physical and mental well being of diabetic females-An interventional study

Dr Saaranyaa S1 个研究点 分布在 1 个国家目标入组 381 人开始时间: 2025年9月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
381
试验地点
1
主要终点
Change in menstrual hygiene practices, measured using a structured questionnaire at baseline and at 2 weeks post-intervention

研究概览

简要总结

This study titled “Menstrual Hygiene Practices and Their Effect on the Physical and Mental Well-Being of Diabetic Females – An Interventional Study” is being conducted among diabetic women attending the Rural Health and Training Centre of Sri Ramachandra Institute of Higher Education and Research, Chennai.

The background recognizes that diabetic females face unique menstrual challenges including irregular cycles, increased susceptibility to infections, stress, poor sleep quality, and lack of family support. Despite this, there is limited research focusing on menstrual hygiene practices in this group.

The study aims to assess menstrual hygiene practices, menstrual waste management, premenstrual symptoms, sleep quality, stress levels, quality of life, and family support among diabetic women, and to evaluate the effect of a short educational intervention (pamphlets in local language and videos) on improving these parameters.

A sample size of 381 has been calculated, of which 100 participants (25%) will receive the intervention. Data will be collected using validated instruments including MPNS-36, DRSP, WHOQOL-BREF, PSS, PSQI, and MSPSS.

  • Primary outcome**:** Change in menstrual hygiene practices.
  • Secondary outcomes**:** Changes in PMS symptoms, stress, sleep quality, quality of life, and perceived family support. Outcomes will be assessed at baseline and at 2 weeks post-intervention.

This short-term study will provide important insights into menstrual health needs of diabetic females, and this simple health education strategies can improve awareness, hygiene practices, and psychosocial well-being.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
19.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • All female peoples aged more than 18 years with Diabetes attending RHTC of Sri Ramachandra institute of higher education and research and who give consent for the study.

排除标准

  • Patients who are not willing to participate in the study
  • Patients with no history of Diabetes mellitus
  • Patients who are Pregnant.

结局指标

主要结局

Change in menstrual hygiene practices, measured using a structured questionnaire at baseline and at 2 weeks post-intervention

时间窗: 2 weeks

次要结局

  • Change in PMS symptoms score, stress levels (PSS), sleep quality (PSQI), quality of life (WHOQOL-BREF), and perceived family support, assessed at baseline and at 2 weeks post-intervention(2 weeks)

研究者

发起方
Dr Saaranyaa S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Saaranyaa S

Sri Ramachandra institute of higher education and research

研究点 (1)

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Menstrual practices among diabetic female | 临床试验