跳至主要内容
临床试验/CTRI/2024/11/077111
CTRI/2024/11/077111尚未招募不适用

Development and validation of a tool to assess for postpartum experiences

Good folks fashion private limited1 个研究点 分布在 1 个国家目标入组 520 人开始时间: 2024年12月2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
520
试验地点
1
主要终点
- subjective information about experiences in the post partum period

研究概览

简要总结

While multiple tools have diagnostic validity and support the screening for PPD, one of the key challenges has been that they do not entirely capture the subjective experiences of women in the postpartum period. The evaluation of the subjective experiences of depression has value in identifying the key target areas that would need to be addressed in the postpartum period to ensure that the women who are suffering from a gamut of mood problems receive the most appropriate and targeted care as needed.

This research project will be conducted in 2 phases - phase one qualitative - where using semistructed interviews, and phenomenological analysis, we will evaluate the experiences of postpartum mothers in the context of their psycho-social environment. in the second phase, the quantitative phase, we will use the tool created from the learnings of the qualitative phase and factor analysis, comprising both exploratory factor analysis (EFA) and confirmatory factor analysis (CFA), will be performed to determine the underlying factors of the new tool. This analysis will involve assessing and validating the tool’s various dimensions. A ROC analysis will be conducted to assess the predictive performance of the new tool, including its sensitivity, specificity, and optimal threshold cut-off values.

the results will be published in peer reviewed journals and in presented in conferences.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Post partum mothers with infants between the ages 1 month to 1 year.
  • they may or may not have symptoms or treatment for postpartum depression.

排除标准

  • not consenting for the study.

结局指标

主要结局

- subjective information about experiences in the post partum period

时间窗: Baseline

- creation of a valid and contextually relevant tool to assess emotional and behavioral symptoms in the post partum period

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
Good folks fashion private limited
申办方类型
Other [Private limited company]
责任方
Principal Investigator
主要研究者

Dr Shiva Prakash Srinivasan

Sree Vikas Centre for Hormones and Mental health

研究点 (1)

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