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临床试验/NCT07537218
NCT07537218已完成不适用

The Effects of Lullabies and White Noise on Breastfeeding Success in Newborns: A Randomized Controlled Trial

Tokat Gaziosmanpasa University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
1
主要终点
LATCH Breastfeeding Assessment Scale Score

研究概览

简要总结

Objective: The study aims to examine the effect of lullabies and white noise on breastfeeding success in newborns.

Method: The study was conducted using a randomized controlled experimental design. The sample size, determined based on power analysis, consisted of 160 newborns, and participants were divided into four groups (female voice lullaby=40, male voice lullaby=40, white noise=40, control=40). Infants in the experimental groups were exposed to the relevant auditory stimulus during breastfeeding, while no intervention was made in the control group. Data were collected using the mother and newborn information form and the LATCH Breastfeeding Assessment Scale.

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
1 Day 至 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age between 38 and 42 weeks Birth weight between 2,500 and 4,000 grams Apgar scores of 8 or higher at 1 and 5 minutes No anatomical, physiological, congenital, or auditory anomalies No family history of childhood hearing loss Healthy newborns for whom parental consent was obtained

排除标准

  • Preterm or post-term newborns (gestational age <37 weeks or >42 weeks) Newborns with congenital anomalies or health problems Mothers with hearing impairment Mothers with communication barriers

研究组 & 干预措施

Control Group:

No Intervention

Control Group: No auditory stimulus was applied. Mothers and newborns were observed under natural conditions with appropriate breastfeeding positioning.

Female Lullaby Group:

Experimental

Female Lullaby Group: Female lullaby (Mircan Kaya - Çamlıbelden Çıktım Yayan) was played at 55 dB during the first 15 minutes of breastfeeding.

干预措施: A Woman's Voice Lullaby (Other)

Male Lullaby Group:

Experimental

Male Lullaby Group: Male lullaby (Kadim Tekin - Çamlıbelden Çıktım Yayan) was played at 55 dB during the first 15 minutes of breastfeeding.

干预措施: A man's voice singing a lullaby (Other)

White Noise Group:

Experimental

White Noise Group: White noise (Orhan Osman - Bebeğiniz Ağlamasın 2) was played at 55 dB during the first 15 minutes of breastfeeding.

干预措施: White Noise (Other)

结局指标

主要结局

LATCH Breastfeeding Assessment Scale Score

时间窗: Within the first 15 minutes of breastfeeding during the first 24 hours after birth

The LATCH scale consists of five subcategories: L (Latching-on), A (Audible swallowing), T (Type of nipple), C (Comfort), and H (Help). Each subcategory is scored on a scale of 0 to 2. The total score ranges from 0 to 10, with a higher score indicating better breastfeeding success.

LATCH Breastfeeding Assessment Tool Score

时间窗: Within the first 15 minutes of breastfeeding at 24 hours postpartum

The LATCH scale consists of 5 components (Latching-on, Audible swallowing, Type of nipple, Comfort, Help) each scored 0-2. Total score ranges from 0 to 10, with higher scores indicating better breastfeeding success.

次要结局

未报告次要终点

研究者

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

ESMA KIR

lecturer

Tokat Gaziosmanpasa University

研究点 (1)

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