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临床试验/NCT05221489
NCT05221489已完成不适用

The Effects of Listening to Lullabies and Self-selected Music at Home on Prenatal Stress and Anxiety in Nulliparous Pregnant Women: A Randomized-controlled Study

Ondokuz Mayıs University2 个研究点 分布在 2 个国家目标入组 134 人开始时间: 2021年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
134
试验地点
2
主要终点
Anxiety change at 2 weeks

研究概览

简要总结

Nulliparous women experience more anxiety and stress during their first transition to motherhood during pregnancy due to inexperience. The aim of this study is to compare the effects of listening to lullabies and the music of their choice at home on reducing the anxiety and stress experienced by nulliparous pregnant women.

This parallel randomized controlled trial was conducted in the obstetrics and gynecology outpatient clinics of a university hospital in eastern Turkey. Lullaby group (LG) recorded only the lullaby chosen by the researcher at home for 30 minutes a day for 2 weeks; mix music group (MG) listened to any of the music recordings presented to them by the researcher. The control group (CG) received general care only. Antenatal stress and anxiety levels were evaluated at the beginning and end of the study.

详细描述

Especially, nulliparous women who have experienced their first pregnancy may lose their control while making the first transition to motherhood and incorporating motherhood roles into other areas of their lives due to inexperience, and may be more vulnerable to stress and anxiety. It has been reported that these pregnant women have higher anxiety than those who have given birth. Antenatal anxiety and stress negatively affect maternal and fetal health. Health care professionals can benefit from music interventions to evaluate the anxiety and stress levels of pregnant women, especially in the last trimester, and to improve their physical, emotional and mental health. In some studies, music interventions made at home for pregnant women reduced anxiety and stress, thus providing psychological benefits during pregnancy, childbirth and postpartum period. The aim of this study is to compare the effects of listening to lullabies and the music of their choice at home on reducing the anxiety and stress experienced by nulliparous pregnant women.

This research is a randomized controlled experimental study in parallel group pretest-posttest design. The research was carried out in the obstetrics and gynecology outpatient clinics of a university hospital in eastern Turkey.

The population of the study consisted of healthy pregnant women who applied to the obstetrics clinic of the hospital where the study was conducted for pregnancy follow-up. G ∗ Power 3.1.9 software was used to calculate the sample size of the study. In the power analysis based on state and trait anxiety inventory scores, at least 35 pregnant women were included in each group with 95% confidence interval (1-α), 95.5% test power (1-β), 0.05 error and d=0.887 effect size. needed was determined. The pregnant women (n=16) included in the study were randomly assigned to the lullaby group (NG) (n=40), mixed music group (MG) (n=40) or control group (CG) (n=40) by simple randomization method. The statistician randomized the participants to intervention groups or control groups with the computer program "Quickcalcs graph pad" (http://www.graphpad.com/quickcalcs/, Accessed: 28.07.2021). Participants were grouped according to the randomization list according to the order of admission to the obstetrics clinic.

Necessary information about the study was given to the pregnant women who were suitable and willing to participate in the study. These pregnant women were randomly assigned to one of three groups after taking their written consent. There were two experimental and one control group in the study. One of the experimental group was a lullaby group and the other was a mixed music group. The control group did not listen to music, did not receive any intervention, received routine general care only during hospital visits.

First of all, sociodemographic and obstetric data of the pregnant women were collected, and their anxiety and stress levels were evaluated at the beginning of the study (pretest) and after 2 weeks of music intervention/general care (posttest). These data were collected at the hospital when pregnant women came to their pregnancy follow-ups.

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)

入排标准

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

入选标准

  • Willing to participate
  • 19 years and older
  • 36th and above gestational week
  • Nulliparous
  • No fetal anomaly
  • Pregnant women who have a WhatsApp application on their phone and can use this application
  • Do not have a psychiatric problem
  • Speaking Turkish

排除标准

  • Unwilling to participate
  • Having a risky pregnancy
  • Below the 36th gestational week
  • Multiparous
  • Fetal anomaly
  • Mental, cognitive, psychiatric, hearing and vision problems
  • Illiterate
  • Do not have WhatsApp application on their phone and cannot use this application
  • Do not speak Turkish

结局指标

主要结局

Anxiety change at 2 weeks

时间窗: At baseline and at the end of the 2nd week of study, anxiety was assessed.

As assessed by the State-Trait Anxiety Inventory

Prenatal stress change at 2 weeks

时间窗: At baseline and at the end of the 2nd week of study, prenatal stress was assessed.

As assessed by the antenatal perceived stress inventory

次要结局

未报告次要终点

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nazlı Baltacı

Assistant Professor, phD

Ondokuz Mayıs University

研究点 (2)

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