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临床试验/NCT06137872
NCT06137872进行中(未招募)不适用

The Effect of Music on Nonstress Test and Pregnant Women's Satisfaction: Randomized Controlled Study

Resmiye KAYA ODABAŞ1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2021年9月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
111
试验地点
1
主要终点
Time to first acceleration

研究概览

简要总结

This study was conducted as a randomized controlled trial. This study was conducted to determine the effect of music on nonstress test and pregnant woman's satisfaction. The study was conducted with pregnant women who applied for non-stress testing at a hospital in Samsun, Turkey, between September 2021 and September 2022. Pregnant women who met the research criteria were divided into two groups: physical and control groups. The research was completed experimentally with a total of 111 pregnant women, 56 experimental and 55 control. The researcher had a face-to-face interview with all the pregnant women and filled out the "Pregnant Introduction Form". Then, the vital signs of the pregnant women were taken and the pregnant women were placed in the left side-lying position. Fundus height, situs and position were determined using Leopold maneuvers. During the non-stress test shooting, the music group was allowed to listen to music for at least 20 minutes during the NST period. No intervention was made to the control group. After the non-stress test is completed, the "Satisfaction Evaluation Scale" is taken by the pregnant woman herself. The "Nonstress Test Monitoring Form" was filled out by the researcher through notification. The data of the study were evaluated using the Statistical Package for the Social Sciences program. All data were first analyzed by Kolmogorov-Smirnov for conformity with normal distribution. were evaluated and then analyzed according to their suitability for normal distribution. For descriptive statistics, percentage across the board, arithmetic mean±standard deviation for those with normal distribution, median and minimum-maximum values for those that did not fit were used. In the analysis of the data, student t test and ANOVA test were used for those that were suitable for normal distribution, and Mann-Whitney U and Kruskal Wallis tests were used for those that were not suitable for normal distribution. Type 1 error level was taken as 0.05.

详细描述

Aim: To determine the effect of music on non-stress test and pregnant woman's satisfaction.

Hypotheses:

H01: There is a difference between the non-stress test results of pregnant women who received music and the control group pregnant women.

H02: There is no difference between the satisfaction levels of pregnant women who received music and the control group pregnant women.

Method: The research was conducted in the non-stress test room in the gynecology outpatient clinic of a hospital in Samsun. The population of the research consisted of pregnant women who applied to the non-stress test room for non-stress test examination after having a pregnancy follow-up at the gynecology outpatient clinic of this hospital.

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 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Criteria for Inclusion of Volunteers in the Research:
  • Are between the ages of 18-35,
  • Pregnancy week 32 and above,
  • Having a singleton and live pregnancy,
  • Have had non-stress test at least once before,
  • Able to speak and understand Turkish,
  • Pregnant women who were at least primary school graduates were included in the study.
  • Conditions to be met before Nonstress Testing
  • Eating at least two hours before the non-stress test,
  • Do not smoke, drink alcohol or use drugs for at least two hours before the non-stress test,
  • Do not engage in vigorous activity for at least two hours before the non-stress test,
  • Nonstress urinates just before the test,
  • Basal heart rate is 110-160 beats per minute

排除标准

  • Criteria for Excluding Preganat in the Research
  • Having uterine contraction as a result of nonstress test,
  • In any situation that develops acutely during the non-stress test,
  • Those who cannot complete non-stress test for any reason,
  • Psychologically diagnosed (such as depression, schizophrenia)
  • Having any chronic disease (such as diabetes, hypertension, heart failure)
  • Having pregnancy complications (such as preeclampsia, gestational diabetes, Rh incompatibility)
  • Having a history of infertility and becoming pregnant with assisted reproductive techniques,
  • Having a problem identified in the fetus (anomaly, intrauterine growth retardation and cardiovascular disease),
  • Pregnant women who provided incorrect or incomplete information were not included in the study.

结局指标

主要结局

Time to first acceleration

时间窗: Immediately after non-stress test

As a result of the non-stress test, the time until the first acceleration was calculated.

Presence of deceleration

时间窗: Immediately after non-stress test

After taking the non-stress test, the presence of deceleration was calculated on the non-stress test paper. After the non-stress test, the presence of deceleration was evaluated as present/absent on the evaluation sheet and, if present, the number was determined.

Presence of acceleration

时间窗: Immediately after non-stress test

After taking the non-stress test, the presence of acceleration was calculated on the non-stress test paper. After the non-stress test, the presence of acceleration was evaluated as present/absent on the evaluation sheet and, if present, the number was determined.

The type of deceleration

时间窗: Immediately after non-stress test

According to the non-stress test results, 1. Early deceleration 2. Late deceleration 3. Variable deceleration evaluation was performed.

Satisfaction Evaluation Scale

时间窗: Immediately after non-stress test

This scale was adapted by researchers similar to the "Visual Analog Scale " usage principles. Visual Analog Scale is a scale evaluated by individuals by making marks on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end indicates that the individual is "very bad". This line can be just a straight line or evenly spaced.

Variability

时间窗: Immediately after non-stress test

After the non-stress test was taken, the variability rate on the non-stress test paper was calculated. 1. Increased variability (change greater than 25 beats/min from basal heart rate) 2. Moderate variability (6-25 beats/min change from basal heart rate) 3. Decreased variability (3-5 beats/min change from basal heart rate) 4. No variability (0-2 beats/min change from basal heart rate)

Fetal heart rate

时间窗: Immediately after non-stress test

After the non-stress test was taken, the basal fetal heart rate on the non-stress test paper was calculated.

Presence of fetal movement

时间窗: Immediately after non-stress test

After the non-stress test was taken, the presence of fetal movement on the non-stress test paper was calculated.After the non-stress test, the presence of fetal movement will be evaluated as presence/absence on the evaluation sheet, and if there is fetal movement, the number is determined.

Nonstress test result

时间窗: Immediately after non-stress test

Evaluations are made according to the nonstress test results 1. Reactive (negative) non-stress test (here should be at least two fetal movements within a 20-minute period, and in parallel with the movements, the fetal heart Accelerations in which the heart rate is more than 15 beats above the basal heart rate and last more than 15 seconds It will be said to be) 2. Nonreactive (positive) non-stress test (Absence of fetal movements or presence of fetal movements within 20 minutes It will be defined as the presence of accelerations that are less than a beat and last less than 15 seconds) 3. Questionable non-stress test evaluation was performed.

次要结局

未报告次要终点

研究者

发起方
Resmiye KAYA ODABAŞ
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Resmiye KAYA ODABAŞ

Research Assistant

Kocaeli University

研究点 (1)

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