此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Can Postpartum Depression Be Prevented With Care

2022年3月21日 更新者：Gulsen Eryilmaz、Ataturk University

Can Postpartum Depression Be Prevented With Care Provided To Primiparas Using Levine's Conservation Model: Single-Blind Randomized Controlled Experimental Study

This study was designed to eliminate postpartum insomnia and fatigue and reduce the risk of postpartum depression through the maintenance of structural, personal, and social integrity with holistic care under the guidance of Levine's conservation model for primiparous puerperal women who experience fatigue and are at risk of developing depression. : A single-blind pretest-posttest randomized controlled study. Women were called to the hospital on the 7th postpartum day and randomly assigned by a computer program to either the intervention group (n=56) or the control group (n=56). Participants did not know which group they were in.

研究概览

地位

完全的

条件

干预/治疗

详细说明

A nursing care program was prepared for the intervention group under the guidance of Levine's conservation model. This program was applied with 7 home visits between the 8th and 80th postpartum days. Face-to-face training and training booklets were provided in home visits. As of the fourth home visit, Pilates exercises were performed. The women in the control group received routine care. Pretest and posttest data were collected with a personal data sheet, visual analogue scale for fatigue, Postpartum Physical Symptom Severity Scale, Postpartum Sleep Quality Scale, Edinburgh Postpartum Depression Scale, and Postpartum Support Scale.

Sleep quality improved for the primiparous puerperal women of the intervention group. They had reduced postpartum fatigue and increased energy; maintained their structural, personal, and social integrity; and had decreased risk of developing postpartum depression with the holistic care provided (all p<0.001). A negative correlation was detected between the support subscale posttest total score from the Postpartum Support Scale and the posttest scores of the Edinburgh Postpartum Depression Scale for the women of the intervention group (r=-0.303; p<0.05)

研究类型

介入性

注册 (实际的)

112

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 火鸡
      • Erzurum、火鸡、25240
        • AtaturkU

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 35年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • primiparous;
  • reading and understanding Turkish;
  • normal term delivery;
  • no risky situations during pregnancy or delivery;
  • high score (≥65 points) from the Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F),
  • score of ≥12 points from the Edinburgh Postpartum Depression Scale (EPDS);
  • episiotomy;
  • hemoglobin value of at least 10.0 mg/dL;
  • no current or past history of psychiatric illness.

Exclusion Criteria:

  • inability to communicate
  • unwillingness to participate in the research.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：The intervention group
To reduce postpartum depression among the primiparous puerperal women in the intervention group, and a nursing care program was implemented under the guidance of Levine's model. This program was applied with 7 home visits between the 8th and 80th postpartum days. Face-to-face training and training booklets were provided in home visits. As of the fourth home visit, Pilates exercises were performed.
行为的：A nursing care program was applied for the intervention group under the guidance of Levine's conservation model.
Face-to-face training and training booklets were provided in home visits. As of the fourth home visit, Pilates exercises were performed.
无干预：The control group
In the control group women received routine postpartum care. No interventions were conducted other than routine postpartum care.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Visual Analogue Scale to Evaluate Fatigue Severity Scores
大体时间：1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
The highest score that can be obtained for the fatigue subdimension is 130 and the lowest score is 0. The highest score that can be obtained from the energy subdimension is 50 and the lowest score is 0. Higher scores on items measuring fatigue and lower scores on items measuring energy indicate that the severity of fatigue is high.
1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
Edinburgh Postpartum Depression Scale Scores
大体时间：1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
The highest score that can be obtained from the scale is 30. A score of 12 or more indicates that the individual is at risk of depression.
1- 7th day after giving birth, Time Frame: 2- postpartum 12th week

次要结果测量

结果测量
措施说明
大体时间
The Postpartum Support Scale Scores
大体时间：1- postpartum 8th day Time Frame: 2- Postpartum 12th week
The lowest score that can be obtained from the scale is 0 and the highest score is 238. The higher the total score, the greater the need for support and the greater the support that needs to be received.
1- postpartum 8th day Time Frame: 2- Postpartum 12th week
the Postpartum Sleep Quality Scale Scores
大体时间：1- postpartum 8th day Time Frame: 2- Postpartum 12th week
The lowest and highest possible scores are respectively 0 and 56. Higher scores indicate lower sleep quality.
1- postpartum 8th day Time Frame: 2- Postpartum 12th week
The Postpartum Physical Symptom Severity Scale Scores
大体时间：1- postpartum 8th day Time Frame: 2- Postpartum 12th week
Total possible scores range between 0 and 54. Higher scores obtained from this scale indicate higher severity of postpartum physical symptoms.
1- postpartum 8th day Time Frame: 2- Postpartum 12th week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ataturk University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年7月1日

初级完成 (实际的)

2020年4月1日

研究完成 (实际的)

2021年3月9日

研究注册日期

首次提交

2022年3月9日

首先提交符合 QC 标准的

2022年3月21日

首次发布 (实际的)

2022年3月24日

研究记录更新

最后更新发布 (实际的)

2022年3月24日

上次提交的符合 QC 标准的更新

2022年3月21日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • AtaturkU-GulsenEryilmaz-001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

There is not a plan to make IPD available

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅