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临床试验/NCT04748653
NCT04748653已完成不适用

Comprehensive Reintegration Assistance for Women With Obstetric Fistula

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Percentage of Planned Intervention Sessions That Were Delivered

研究概览

简要总结

This is a pilot study to test the feasibility and acceptability of a multi-component facility-based intervention designed to be provided adjunct to genital fistula surgery incorporating: health education, psychosocial counseling, physiotherapy, and economic investment. We will include a total of 30 women in the study, and follow them for 6-months using a mixed-methods strategy for feasibility and acceptability assessment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Undergoing surgery for female genital fistula
  • Age 18 or above, or emancipated minor per Ugandan law

排除标准

  • No further criteria

结局指标

主要结局

Percentage of Planned Intervention Sessions That Were Delivered

时间窗: 6 weeks

Number of planned intervention session over the total number of planned interention sessions

Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Overall Experience With the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants.

时间窗: 6 weeks

Number of participants reporting to be "satisfied" or "very satisfied" about their overall experience participating in the intervention on a five-point Likert scale at six weeks over the total number of participants.

次要结局

  • Change in Reintegration Score(Baseline and 6 months)
  • Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Health Education Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants(6 weeks)
  • Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience Participating in the Psychosocial Counseling Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Participants.(6 weeks)
  • Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Physiotherapy Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants.(6 weeks)
  • Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Economic Empowerment Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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