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临床试验/NCT06293274
NCT06293274已完成不适用

The Effect of Discharge Education on Maternity Blues and Postpartum Depression

Kocaeli University2 个研究点 分布在 2 个国家目标入组 140 人开始时间: 2024年1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
140
试验地点
2
主要终点
Motherhood Sadness Scale

研究概览

简要总结

The study will be conducted with participants who will give birth at Farabi Training and Research Hospital in Darıca District, Kocaeli Province.

The sample size of the study was calculated using the G*Power 3.1.9.2 program, and the effect size of the Edinburgh Postnatal Depression Scale (EPDS) score in the Sun et al. (2021) study was considered in the effect size calculation. In the relevant article, the effect size is reported as effect size: 0.47. In our planned research, the minimum number of individuals to be sampled was calculated using G*Power 3.1.9.2 with effect size: 0.47 α= 0.05, power: 0.80, and the sample size was set at a minimum of 57 participants in each group. In anticipation of possible data loss, the study will be completed with a total of 140 participants, including 70 cases and 70 routine discharge training groups. This research aims to determine the effect of discharge training on maternal blues and postpartum depression on the levels of maternal blues and postpartum depression during postpartum follow-up.

详细描述

The purpose of this study is to determine the effect of discharge training on maternal sadness and postpartum depression on the level of maternal sadness and postpartum depression in the puerperium follow-up. In this context, the hypotheses of the study are as follows;

Hypothesis 1:

H0: There is no difference in the total scores of the Maternal Sadness Scale used in the postpartum follow-up of mothers who received discharge training on maternal sadness and postpartum depression and mothers who did not receive training.

H1: There will be a difference in the total scores of the Maternal Sadness Scale used in the postpartum follow-up of mothers who received discharge education on maternal sadness and postpartum depression and mothers who did not receive education.

Hypothesis 2:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Those who gave birth between weeks of gestation,
  • Those who have had vaginal birth or caesarean section,
  • Able to speak and understand Turkish,
  • Those over 18 years of age,
  • Mothers with a single healthy baby
  • Those with an Edinburgh Postnatal Depression Scale score of 9 or less in depressive symptoms screening

排除标准

  • Preterm or postterm birth,
  • Received psychiatric treatment or used psychotropic medications during pregnancy,
  • Having a history of substance dependence and/or use in the past 6 months,
  • Being in the high-risk category,
  • Interventional/instrumented birth (Kiwi, vacuum, crystal maneuver),
  • Mothers having babies with congenital malformations requiring intensive care intervention (small for gestational age, mort de fetus, fetus without major pathology according to ultrasonography).
  • Participants who wish to withdraw from the study at any time will not be included in the study.

结局指标

主要结局

Motherhood Sadness Scale

时间窗: 5-7 days of the postpartum period after the mother's discharge. It will be obtained by the researcher by telephone on the following days.

The scale developed to evaluate motherhood blues consists of 32 items and 8 sub-dimensions. These sub-dimensions; skin-to-skin contact, communication, staying in the same room, breastfeeding, physical adaptation, responsibility, culture, economic factors, information and economic support, social support. Scale items contain positive and negative expressions. The scale is graded as 'completely appropriate (5 points), appropriate (4 points), rarely appropriate (3 points), not appropriate (2 points), not at all appropriate (1 point). The minimum score that can be obtained from the scale is 32 and the maximum score is 160. A high total score in the evaluation of the scale indicates experiencing motherhood blues.

Edinburgh Postnatal Depression Scale - EPDS

时间窗: At 6 weeks postpartum, the researcher will call and administer the 10-item Edinburg Postpartum Depression Scale.

The scale consists of 10 items. Items are evaluated in a 4-point Likert format and scored between 0-3. The lowest score that can be obtained from the scale is 0 and the highest score is 30. Although the cut-off scores for the scale vary between studies, it is stated that a cut-off score of 12 may be sufficient to determine clinical depression. The scale is a screening scale to determine the risk of postpartum depression.

次要结局

未报告次要终点

研究者

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

sena dilek

Principal Investigator

Kocaeli University

研究点 (2)

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