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临床试验/NCT06053931
NCT06053931尚未招募不适用

The Effect of Music on Neonatal Stress, Mother's Breastfeeding Success and Comfort During Breastfeeding: a Randomized Controlled Trial

Celal Bayar University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
mother's comfort in lullaby group

研究概览

简要总结

In the literature, music plays an energizing, soothing, stimulating and awakening role for the newborn, and at the same time, music has the potential to wake up a lethargic and withdrawn baby and calm a crying, restless baby. In addition, it is stated that relaxing music in the early postpartum period supports breastfeeding behaviors of mother and baby. It is stated that lullabies positively affect the newborn's relaxation, falling asleep, and mother-baby communication. however, it facilitates sleep due to its monotonous, emotional and repetitive melody structure, slow tempo and relaxing effect. The sound called white noise is a humming, monotonous and constantly used sound that suppresses the disturbing sounds coming from the environment and has a calming feature. In the literature, it has been found that white noise played to infants with colic reduces crying.

The aim of this study is to determine the effects of lullabies and white noise music played during breastfeeding of the newborn on newborn stress, breastfeeding success and mother's comfort. This study was planned as a randomized controlled trial with term newborns 24 hours after birth.

详细描述

The hypotheses are presented below;

H1- White noise music played during breastfeeding reduces newborn stress compared to the control group.

H2- White noise music played during breastfeeding increases breastfeeding success compared to the control group.

H3- White noise music played during breastfeeding increases comfort of the mother compared to the control group.

H4- Lullaby music played during breastfeeding reduces newborn stress compared to the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The population of the research is consisted of mothers who have just given birth and are hospitalized in the obstetrics and gynecology service at Izmir Bakırçay University Çiğli Training and Research Hospital.

No sample selection is made in the research, and all mothers who meet the inclusion criteria and accept the research is constituted the sample.

Randomization will be provided to newborns and mothers using the simple randomization method according to their protocol numbers and by using the website https://www.randomizer.org/.

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

  • Over 18 years of age,
  • Able to speak Turkish,
  • Breastfeeding mothers
  • Term and healthy newborn (born at 38-42 weeks, weighing 2500-4000 g, born with an APGAR of 7 or more, without any known congenital disease)

排除标准

  • mothers who do not agree to participate in the research
  • mother has a condition that prevents breastfeeding

结局指标

主要结局

mother's comfort in lullaby group

时间窗: from pre-intervention to 15 minutes after listening to lullaby.

Change in mother's comfort from pre-intervention to 15 minutes after listening to lullaby during breastfeeding.

newborn stress level in white noise group

时间窗: from pre-intervention to 2 minutes after listening to white noise music.

Change in newborn stress level from pre-intervention to 2 minutes after listening to white noise music in the first minute of breastfeeding. "Newborn Stress Scale" including facial expression, color, respiration, activity level, consolation, muscle tone, extremities, and posture. Each parameter was scored on a scale of 0-2. The minimum score was 0, and the maximum score was 16 for this scale, where a higher score represented increased stress levels in newborn.

newborn stress level in lullaby group

时间窗: from pre-intervention to 2 minutes after listening to lullaby.

Change in newborn stress level from pre-intervention to 2 minutes after listening to lullaby. "Newborn Stress Scale" including facial expression, color, respiration, activity level, consolation, muscle tone, extremities, and posture. Each parameter was scored on a scale of 0-2. The minimum score was 0, and the maximum score was 16 for this scale, where a higher score represented increased stress levels in newborn.

mother's comfort in white noise group

时间窗: from pre-intervention to 15 minutes after listening to white noise music

Change in mother's comfort from pre-intervention to 15 minutes after listening to white noise music during breastfeeding. The number "0" on the the Visual Analog Scale indicates that it is not comfortable at all, the comfort increases as the numbers get larger, and the number "10" indicates that the comfort is complete.

次要结局

  • breastfeeding success in white noise group(At the 15th minute of breastfeeding)
  • breastfeeding success in lullaby group(At the 15th minute of breastfeeding)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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