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临床试验/NCT04986475
NCT04986475已完成不适用

The Effect of Music Therapy on High Risk Pregnant Women of Non-Stress Test and Anxiety Levels

Selcuk University2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2021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
116
试验地点
2
主要终点
Non stress test evaluation form

研究概览

简要总结

Non-stress testing (NST) is one of the most commonly used methods to assess fetal health in the prenatal period because it is an easily interpreted, non-invasive, painless, and short-term diagnostic method. Although NST is a non-invasive and painless diagnostic method, pregnant women may feel anxiety during the procedure.

It is supported by studies that listening to music causes relaxation and reducing anxiety. Therefore, the use of music as a non-pharmacological practice will increase the quality of care of individuals. There are many studies suggesting that music reduces anxiety in low-risk pregnancies during NST application. Different instruments such as ney, rebab, kopuz, dombra are used in Turkish music. In particular, ney has come to the fore in music therapy. The ney, which has different types in history, is an instrument that is closest to the human voice. In a compilation about the music used in music therapy in Turkey, it was stated that there are many social and health studies made with the sound of ney. Determining the effect of music on NST and anxiety in high-risk pregnant women will contribute to the literature.

详细描述

Non-stress testing (NST) is one of the most commonly used methods to assess fetal health in the prenatal period because it is an easily interpreted, non-invasive, painless, and short-term diagnostic method. Although NST is a non-invasive and painless diagnostic method, pregnant women may feel anxiety during the procedure.

It is supported by studies that listening to music causes relaxation and reducing anxiety. Therefore, the use of music as a non-pharmacological practice will increase the quality of care of individuals. There are many studies suggesting that music reduces anxiety in low-risk pregnancies during NST application. Different instruments such as ney, rebab, kopuz, dombra are used in Turkish music. In particular, ney has come to the fore in music therapy. The ney, which has different types in history, is an instrument that is closest to the human voice. In a compilation about the music used in music therapy in Turkey, it was stated that there are many social and health studies made with the sound of ney. Determining the effect of music on NST and anxiety in high-risk pregnant women will contribute to the literature.

The aim of this study is to determine the effect of music therapy on NST and anxiety levels in high-risk pregnant women.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

In order to ensure randomization in the study, a random numbers table was created by dividing them into two groups based on the number determined on the site https://www.randomizer.org/. In order to prevent bias, in order to divide the women into groups according to the randomization list, the groups were written and sealed in two separate opaque envelopes as intervention (the ney sound is played during the NST procedure) and control (the routine NST procedure was applied). Double blinding was done on request.

入排标准

年龄范围
19 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • over 18 years old
  • Those diagnosed with high-risk pregnancy by a physician (pregnancy-induced hypertension, preeclampsia, eclampsia, gestational diabetes, premature rupture of membranes, pregnancy large or small for gestational age, intrauterine growth retardation, pain/contraction, oligohydramnios, premature birth threat, maternal age 35 age and above, maternal body mass index over 30 (obesity))
  • Speaking and understanding Turkish
  • Pregnant women with a single fetus
  • 32-41 weeks of pregnancy

排除标准

  • having twin pregnancy
  • with heart disease,
  • fetal distress,
  • having a fetus with anomaly,
  • hereditary anemia,
  • pregnant women with sexually transmitted diseases

结局指标

主要结局

Non stress test evaluation form

时间窗: up to one hour

It was created by researchers in order to record and evaluate the findings related to the NST procedure. In the NST evaluation form, fetal heart rate and variability, which were followed for at least 20 minutes, number of accelerations, decelerations and fetal movements, test result (reactive or nonreactive) were included.

次要结局

  • State-Trait Anxiety Inventory (STAI)-Questionnaire(up to one hour)

研究者

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

Yasemin ERKAL AKSOY

Lecturer Dr

Selcuk University

研究点 (2)

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