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临床试验/NCT05214846
NCT05214846已完成不适用

The Effect of Education and Counseling on Reducing Anxiety and Depression in Nullipar Pregnancy Women

Ondokuz Mayıs University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Hospital Anxiety Depression Scale (HADS)

研究概览

简要总结

This study investigates the effect of education and counseling on anxiety and depression in nullipar women.

详细描述

Pregnancy is a special process in a woman's life in which physiological, social and psychological changes occur. In this process, most women experience anxiety and depression, which are an important global health problem.The fear of uncertainty experienced by women who will become mothers for the first time may cause them to experience more anxiety/depression. The aim of this study was to investigate the effect of education and counseling on anxiety and depression of women.

This randomized controlled study was conducted at state hospital in northern Turkey , Obstetrics and Gynecology polyclinic between January 2022 and March 2022. Volunteer women undergoing polyclinic have been included. Participants were randomly assigned to the intervention or the control group using a computer-generated list. A data collection form including socio-demographic and obstetric characteristics such as age, educational status, Hospital Anxiety Depression Scale (HADS) was used for each patient. After obtaining written informed consent, the data collection form, Hospital Anxiety Depression Scale (HADS) were applied to both groups by face to face interview. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed.The IBM SPSS (Statistical package for the Social Sciences) 23.0 package program was used to evaluate the data obtained in the study.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • A healthy pregnant woman over 18 years of age,
  • without a diagnosed psychiatric disease,
  • without mental disability and communication problems,
  • at 28 weeks of gestation,
  • nulliparous,
  • without fetal anomaly,
  • without risky pregnancy

排除标准

  • A healthy pregnant woman under 18 years of age,
  • with a diagnosed psychiatric disease,
  • with mental disability and communication problems,
  • under 28 weeks of gestation,
  • multiparous,
  • with fetal anomaly,
  • with risky pregnancy

结局指标

主要结局

Hospital Anxiety Depression Scale (HADS)

时间窗: 30 minutes

The HADS contains 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal' (Zigmont ve Snaith).

次要结局

未报告次要终点

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sümeyye BAL

Lecturer Dr.

Ondokuz Mayıs University

研究点 (2)

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