Effect of Quiet or Listening to Music While Breastfeeding on the Production and Lipid and Sodium Content of the Milk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Volume of milk in ten minutes
研究概览
简要总结
A mother of a preterm infant listening to music while pumping her breasts will produce more milk than a similar mother who is not listening to music. A mother listening to live music will produce more milk than a mother listening to recorded music
详细描述
- Purpose of the study. The purpose of this study is to determine whether listening to music under three conditions: (1) when a music practitioner is playing background harp music, (2) when a CD is playing exactly the same background harp music, or (3) when no background music is being played will have an effect on the flow, lipid (fat), or the sodium content of breast milk.
PRIMARY HYPOTHESES: (1) A primiparous mother of a preterm infant listening to music while pumping her breasts will produce more milk than a similar mother who is not listening to music. (2) A mother listening to live music will produce more milk than a mother listening to recorded music.
EXPLORATORY HYPOTHESIS: (1) The milk of a mother listening to music while pumping her breasts will have higher lipid content and lower sodium content than a mother who is not listening to music.
PRIMARY OBJECTIVE: This pilot study will investigate the feasibility of measuring the amount of breast milk produced by mothers who are pumping breast milk for their preterm infant under one of three conditions: (1) when a music practitioner is playing background harp music, (2) when a CD is playing exactly the same background harp music, or (3) when no background music is being played.
II. CHARACTERISTICS OF THE RESEARCH POPULATION
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •First time mothers between the ages of 18 and 45 who have had a vaginal or caesarean delivery and are feeling well.
- •First time mothers are used to avoid confounding variables due to previous positive or negative experiences from expressing milk. Their infant will have been born at less than 32.0 weeks of gestation.
- •Mothers will intend to breastfeed and are planning to pump milk on site in the NICU at least once/day and will be recruited 7-10 days postpartum.
- •Mothers who smoke, are taking medication that may interfere with breastfeeding, and who have undergone prior breast surgery will not be excluded since they are their own control.
- •With regard to language, mothers must be able to understand the directions and sign a consent form in English.
排除标准
- •Mothers will not be recruited whose infant has a low likelihood of survival as determined by the attending physician.
- •Mothers who have been diagnosed with mastitis will not be recruited for the study.
研究组 & 干预措施
no music
The mother will be randomized to receive each od three experimental conditions: live music, recorded music, no music in random order over the course of three pumping sessions. She will then experience all three conditions again in random order
live music
The mother will be randomized to receive each od three experimental conditions: live music, recorded music, no music in random order over the course of three pumping sessions. She will then experience all three conditions again in random order
干预措施: live music (Behavioral)
recorded music
The mother will be randomized to receive each od three experimental conditions: live music, recorded music, no music in random order over the course of three pumping sessions. She will then experience all three conditions again in random order
干预措施: recorded music (Behavioral)
结局指标
主要结局
Volume of milk in ten minutes
时间窗: 10 days
Milk volume in Ml.
次要结局
- Milk lipid(10 days)
- Milk sodium(10 days)
研究者
Carl D'Angio
Professor, Department of Pediatrics, Neonatology
University of Rochester