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临床试验/NCT05295069
NCT05295069已完成不适用

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

Ataturk University1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
1
主要终点
Visual Analogue Scale to Evaluate Fatigue Severity Scores

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

All participants did not know which group they were in.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

The intervention group

Experimental

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.

干预措施: A nursing care program was applied for the intervention group under the guidance of Levine's conservation model. (Behavioral)

The control group

No Intervention

In the control group women received routine postpartum care. No interventions were conducted other than routine postpartum care.

结局指标

主要结局

Visual Analogue Scale to Evaluate Fatigue Severity Scores

时间窗: 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.

Edinburgh Postpartum Depression Scale Scores

时间窗: 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.

次要结局

  • The Postpartum Physical Symptom Severity Scale Scores(1- postpartum 8th day Time Frame: 2- Postpartum 12th week)
  • The Postpartum Support Scale Scores(1- postpartum 8th day Time Frame: 2- Postpartum 12th week)
  • the Postpartum Sleep Quality Scale Scores(1- postpartum 8th day Time Frame: 2- Postpartum 12th week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gulsen Eryilmaz

Prof. Dr. Gulsen ERYILMAZ

Ataturk University

研究点 (1)

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