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临床试验/NCT06199622
NCT06199622已完成不适用

The Effect of Music on Anxiety Levels, Blood Pressure, Fetal Heart Rate and Maternal-Fetal Attachment in Pregnant Women With Gestational Hypertension

Saglik Bilimleri Universitesi2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年4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
90
试验地点
2
主要终点
anxiety

研究概览

简要总结

In this study, the effect of music on arterial blood pressure, anxiety level, fetal heart rate and maternal-fetal attachment in pregnant women with gestational hypertension will be studied and it will be conducted as a randomized controlled intervention study to examine the relationships with each other. The sample group will consist of 90 pregnant women, 45 in the intervention group and 45 in the control group. Within the scope of the study, the data will be collected using the 'Personal Information Form, State-Trait Anxiety Scale (STAI TX-I)', Maternal-Fetal Attachment Scale (MFA) created by the researcher, and the systolic blood pressure and diastolic blood pressure of each patient will be measured with a calibrated sphygmomanometer (the same sphygmomanometer was used for each patient), fetal heart rate (FHR) and fetal movements (FM) will be measured by Electronic Fetal Monitoring and Nonstress test (NST). Data will be analyzed using SPSS-25 package.

详细描述

In this study, the effect of music on arterial blood pressure, anxiety level, fetal heart rate and maternal-fetal attachment in pregnant women with gestational hypertension will be studied and it will be conducted as a randomized controlled intervention study to examine the relationships with each other. The sample group will consist of 90 pregnant women, 45 in the intervention group and 45 in the control group. Within the scope of the study, the data will be collected using the 'Personal Information Form, State-Trait Anxiety Scale (STAI TX-I)', Maternal-Fetal Attachment Scale (MFA) created by the researcher, and the systolic blood pressure and diastolic blood pressure of each patient will be measured with a calibrated sphygmomanometer (the same sphygmomanometer was used for each patient), fetal heart rate (FHR) and fetal movements (FM) will be measured by Electronic Fetal Monitoring and Nonstress test (NST). Data will be obtained by the researcher by face-to-face interviews with pregnant women. In addition, pregnant women in the intervention group will be given music once a day for 20 minutes at the beginning of the study. Pregnant women in the control group will continue their routine care. Data will be evaluated with SPSS-25 package.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women hospitalized with a diagnosis of Gestational Hypertension/Mild Preeclampsia (Severe Preeclamptic Pregnant Women were not included in the study),
  • Pregnancy at 28 weeks of gestation and above (since NST will be performed during follow-up),
  • No hearing problems (because music will be played),
  • Good level of consciousness,
  • Being at least literate (for consent to be obtained),
  • Being over 18 years of age (for consent to be obtained),
  • No communication problems,
  • A live, single, healthy fetus.
  • Pregnant women who verbally and in writing agreed to participate in the study

排除标准

  • Written and verbal refusal to participate in the research,
  • Illiteracy,
  • Must be under 18 years of age,
  • Communication problems,
  • Hearing problems,
  • Before the 28th week of pregnancy,
  • Hospitalized for less than three days with a diagnosis of Gestational Hypertension/Preeclampsia,
  • Hospitalized with a diagnosis of severe pre-eclampsia,
  • Multiple pregnancies.

结局指标

主要结局

anxiety

时间窗: 6 months

Anxiety will be measured with State-Trait Anxiety Inventory (STAI TX-I) before and after the intervention. The scale consists of 20 items on a 4-point Likert scale ((1) not at all, (2) a little, (3) a lot, (4) completely). The total score value obtained can vary between 20 and 80. A high score indicates a high level of anxiety and a low score indicates a low level of anxiety.

vital signs

时间窗: 6 months

Blood pressure (mm/Hg) of pregnant women will be measured with a calibrated sphygmomanometer.

maternal fetal attachment

时间窗: 6 months

Changes in mother-infant attachment will be measured with the Maternal-Fetal Attachment Scale (MFA) before and after the intervention. Responses are scored from 1-5, with 5 being the most positive statement. The higher the score, the higher the attachment.

Fetal heart rate

时间窗: 6 months

Nonstress test (NST) will be performed with Electronic Fetal Monitoring for an average of 20 minutes and fetal heart rate (beats per minute) will be recorded.

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

Büşra Güngör

master student

Saglik Bilimleri Universitesi

研究点 (2)

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