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临床试验/NCT04433637
NCT04433637已完成不适用

Effect of Listed Music With Motivational Video And Nutrition on Non-Stress Test and Anxiety Level of Mother: Randomized Controlled Clinical Research

Inonu University2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2018年4月25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
360
试验地点
2
主要终点
Effect of nutrition

研究概览

简要总结

Objective: The research was conducted to determine the effect of music and nutrition played together with motivational video on non-stress test (NST) result and mother's anxiety level.

Method: The study was conducted as a randomized controlled clinical trial. The sample of the study consisted of 360 pregnant women, two experimental and one control group (120 pregnant women in each). In the study, pregnant women in the first experimental group were provided to consume cake and fruit juice 30 minutes before the NST procedure. The second experimental group was provided to eat fruit juice and cake before NST, and the video created with a similar content was given about the developments and changes occurring in the mother and fetus during pregnancy, and was watched for about 15-20 minutes during the NST procedure accompanied by music that provided relaxation. The data of the study were collected by using the Participant Presentation Form, NST evaluation form and State Anxiety Inventory.

详细描述

Non Stress Test (NST) has been used frequently in fetal health assessment in recent years due to its easy application, cheapness, reliability and rapid assessment. False negativity rates of NST also cause an increase in cesarean rates. Studies in recent years show that there are methods and factors that increase fetal movements and shorten NST application time. It was observed that nutrient intake, music playing, fetal acoustic vibration application and halogen light applications before NST increased fetal movements and shortened NST time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

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

  • Being 18 or over
  • Being pregnant more than 32 weeks gestation,
  • Having at least one live birth,
  • Having had NST before,

排除标准

  • Having any risk factor (preeclampsia, IUGG, early membrane rupture, getational diabetes etc.) during pregnancy
  • Urinary contraction after NST,
  • It is a cardiovascular disease diagnosed in the fetus.

结局指标

主要结局

Effect of nutrition

时间窗: 1 month

questionnaire NST Findings Registration Form As Reactive NST; The test result was accepted as reactive NST in the presence of at least two accelerations, which lasted at least 15 seconds within the 20-minute period when the electronic fetal heartbeat traces were printed and was 15 beats / minute more than the baseline beat. As nonreactive NST; The absence of at least two accelerations, which lasted at least 15 seconds within the 20-minute period when the electronic fetal heartbeat traces were printed, was 15 beats / minute more than the baseline beat, or 160 beats / minute and above continuous fetal tachycardia in the presence of severe variable decelerations and late decelerations. In case of development, the result was evaluated as nonreactive NST.

Effect of music with motivational video

时间窗: 1 month

scale State Anxiety Scale The state anxiety part of the scale consisting of two parts was used. Answer options on both scales consisting of twenty questions can get points from 1 to 4. There are direct and inverted expressions in the scales. Direct expressions express negative emotions, and reversed expressions express positive emotions. There are ten reversed expressions in the WHO and these are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. The total score value obtained from the scale varies between 20 and 80. The increase in the score obtained from the scale indicates that the level of anxiety is high.

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

Gülçin NACAR

Principal Investigator

Inonu University

研究点 (2)

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