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临床试验/NCT02739178
NCT02739178终止不适用

The Sukhshanti Study: a Controlled Before-and-after Mixed Methods Study of the Effect of a Sanitation Intervention on Women's Health in Bihar, India

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 1,275 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1,275
试验地点
2
主要终点
Sanitation-Related Psychosocial Stress Scale (SRPS)

研究概览

简要总结

The study will measure the impact of sanitation access on women and girl's social and emotional health, behaviors, and quality of life in rural India before and after a sanitation intervention compared to a comparison group that will receive the same intervention at a later date.

详细描述

This mixed-methods, quasi-experimental study will evaluate the extent to which the Global Sanitation Fund (GSF) sanitation program in Bihar, India improves health and well-being among women and girls. Our study consists of a controlled before-and-after (CBA) study with an embedded ethnography.

Specific objectives are:

  • Measure the effect of the GSF intervention on sanitation-related psychosocial stress (SRPS), generalized psychosocial stress (PSS), perceived quality of life, hair cortisol, and urogenital health among women between the ages of 14 and 65.
  • Measure changes in sanitation adoption (e.g.: sanitation access and exclusive use) among individuals / households receiving the GSF intervention.
  • Document individual and community experiences with sanitation, intervention participation, and latrine coverage through ethnographic methods.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • between 14 years to 65 years old
  • live in geographic area receiving GSF sanitation intervention in 2016
  • live in geographic areas matched to intervention communities

排除标准

  • less than 25 years old and not reached menarche
  • greater than 25 years old and never married
  • refusal to participate

结局指标

主要结局

Sanitation-Related Psychosocial Stress Scale (SRPS)

时间窗: 12 month follow-up

The SRPS consist of 25 yes/no questions on experiences related to sanitation within the past thirty days of the date the SRPS is completed.This SRPS Scale specifically includes questions related to defecation, menstrual hygiene management, and post-defecation cleaning - the three behaviors that have the greatest contribution to sanitation-related psychosocial stress among women in India.

次要结局

  • Kessler Psychological Distress Scale (K10)(12 month follow-up)
  • The WHO5 Well-Being Index (WHO-5)(12 month follow-up)
  • Self-reported urogenital infections(12 month follow-up)
  • Perceived Stress Scale (PSS10)(12 month follow-up)
  • Hair cortisol(12 month follow-up)
  • Sleep duration(12 month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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