跳至主要内容
临床试验/NCT06110819
NCT06110819招募中不适用

Individual Training Given to Pregnant Women in the Earthquake Zone in Their Living Spaces, the Effect of Pregnancy Follow-up on Prenatal Comfort, Distress, Risk Perception and Birth Anxiety.

Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年2月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
64
试验地点
2
主要终点
Pregnancy Risk Perception Scale

研究概览

简要总结

This study aims to evaluate the effect of individual training and pregnancy follow-up given to pregnant women in the earthquake zone in their living spaces on prenatal comfort, distress, risk perception and birth anxiety.

In the randomized controlled experimental study, data will be obtained using the Personal Information Form, Pregnant Observations and Birth Results, Prenatal Comfort Scale, Prenatal Distress Scale, Pregnancy Risk Perception Scale, Oxford Birth Anxiety Scale.

详细描述

In the literature, it has been reported that the earthquake had a negative impact on pregnant women, as well as material and loss of life (Amarpoor Mesrkanlou, et al. 2023; Kyozuka, et al. 2022; Nishigori, et al. 2014; Watanabe, et al. al. 2016). In the study of İlavaten Mesrkanlou et al (2023); It has also been reported that post-earthquake causes insufficient weight gain in pregnant women, decreased hemoglobin levels, and adverse birth outcomes. (Amarpoor Mesrkanlou, et al. 2023). Again, in the research of Kyozuko et al., (2022); It has been reported that pregnancy complications such as gestational hypertension, respiratory diseases and mental disorders increased in pregnant women after the earthquake (Kyozuka, et al. 2022). In their study, Mesrkanlou et al., (2023) reported postpartum depression as 21.3% in 633 pregnant women in the regions affected by the East Japan earthquake (Nishigori, et al. 2014). Watanabe, et al. (2016) reported psychological distress among pregnant women in the Miyagi region of Japan as 4.9% in their study (Watanabe, et al. 2016). In addition, the earthquake may result in negative effects during pregnancy, such as premature birth, low birth weight and hypertensive disorders. (Hawkins, et al. 2019; Lian, et al. 2020; Palmeiro-Silva, et al. 2018). As a result of the 6.3 magnitude earthquake in Christchurch, New Zealand, premature birth was reported as 6.71% in 1057 pregnant women (Hawkins, et al. 2019). In addition, in the study that examined the relationships between earthquake exposure of pregnant women and negative birth outcomes and included 73,493 women, pregnant women exposed to the earthquake had a 2% higher rate of stillbirth and 14.14% higher preterm birth compared to pregnant women not exposed to the earthquake (Lian, et al. 2020). ).

In this context, increased levels of anxiety and depression during pregnancy may affect the comfort level of the pregnant woman (Matvienko-Sikar and Dockray 2017). In addition, prenatal stress is defined as the emotional reactions of the pregnant woman in terms of physical, psychological and social changes that occur during pregnancy, birth, parenthood and baby health (O'Hara and Wisner 2014). Again, inadequate prenatal care increases perinetal stress (Gooijers and Swinnen 2014). In a study conducted in Turkey, it was reported that perinetal stress affected preterm birth the most during pregnancy (Yuksel, et al. 2014). Pregnant women are among the most vulnerable people who may need special support in the event of an earthquake. Therefore, pregnant women should be provided with stronger support after the earthquake.

For this reason, it is important to provide and maintain the care of pregnant women face to face by health professionals after the earthquake (Yamashita, et al. 2019). In addition, the education given to pregnant women is also effective in preventing premature birth and postpartum depression (Çankaya and Şimşek 2021; Dennis and Dowswell 2013). In addition, it has been reported in the literature that the satisfaction of pregnant women is increased with the different education models (home visits, medical care, individualized care) provided during pregnancy. (MOUNTAINS, et al. 2015; Fernandez Turienzo, et al. 2020; Shen, et al. 2022; Swift, et al. 2021). In a meta-analysis study, education during pregnancy reported that women were prepared for pregnancy complications (Ketema, et al. 2020). Lack of information and fear of the unknown during pregnancy and birth increase the stress of pregnant women (Uludağ, et al. 2022).

These results emphasize the need for follow-up and education of pregnant women in order to reduce the negative effects on pregnant women after the earthquake. It is thought that individual training and pregnancy follow-up given to pregnant women in the earthquake zone in their living spaces will increase prenatal comfort and reduce the effects of distress, risk perception and birth anxiety.

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
Single (Outcomes Assessor)

盲法说明

Analyzes will not be made by the researcher.

入排标准

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

入选标准

  • Ability to speak Turkish,
  • First pregnancy
  • Agreeing to participate in the study
  • 14 weeks pregnant

排除标准

  • Pregnant women who do not continue the program.
  • Attending a pregnancy education class

结局指标

主要结局

Pregnancy Risk Perception Scale

时间窗: 15 minutes before the training, 15 minutes after the training is completed

Each item in the scale has a linear line of 0-10 cm (0-100 mm), and at the two ends of these lines are the expressions "no risk" and "extremely high risk". The total score of the scale is obtained by summing the scores of the nine items and dividing the resulting score by 9. A scoring can also be made for the factors of the scale: Similar to the total score calculation, it is calculated by dividing the sum of the scores from the relevant sub-dimensions of the scale by the number of items in that sub-dimension. The scale has no cut-off point. An increase in the score obtained from the scale indicates that the risk perception of the pregnant woman for herself and her baby increases.

Prenatal Comfort Scale

时间窗: hrough study completion, an average of 1 week

The scale is evaluated out of a total of 75 points. It is interpreted that as the score decreases, the comfort level also decreases, and as the score increases, the comfort level also increases. The scale has no reverse-scored items and no cut-off points.

Prenatal Distress Scale

时间窗: 15 minutes before the training, 15 minutes after the training is completed

The total score of the items is taken as a value between 0-34. Yuksel et al. The cut-off value of the scale has not been calculated and a high score from the scale indicates a high level of prenatal distress.

Oxford Birth Anxiety Scale:

时间窗: 15 minutes before the training, 15 minutes after the training is completed

Women's concerns about the birth process were evaluated with a four-point Likert scale. Scale; It can be applied to women in all periods before, during and after birth; It was scored as "1: I was very worried", "2: I was quite worried", "3: I was not very worried", "4: I was not worried at all". The scale is evaluated based on the total score (min = 10, max = 40). It is interpreted that as the score increases, women's anxiety level decreases. The scale, which has three subscales: "pain and distress", "prenatal uncertainty" and "interventions", does not have reverse questions.

次要结局

未报告次要终点

研究者

发起方
Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mine Gokduman Keles

DR.Midwifery

Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate

研究点 (2)

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