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临床试验/NCT00930761
NCT00930761已完成不适用

A Randomized Controlled Trial to Evaluate the Effects of Music Therapy on Breastfeeding Rates Among Mothers of Premature Newborns

Universidade Federal do Rio de Janeiro2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2004年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
2
主要终点
Maternal Breastfeeding at Infant Discharge

研究概览

简要总结

The purpose of this study is to evaluate the impact of music therapy on breastfeeding rates among mothers of premature newborns.

Hypothesis: Music therapy applied to mothers of premature newborns increases the rates of maternal breastfeeding at the time of the infant hospital discharge and at follow-up visits.

详细描述

Music therapy has been shown to have positive effects in several areas such as mental health, special education, rehabilitation and social development. Its use as a means to facilitate communication and expression of emotional contents was shown to be able to promote relief of anxiety, fears and tensions. However, in the maternal and child health area there are still few studies demonstrating the contribution of this therapy in the promotion of health and no study evaluating specifically the impact of this intervention on the rates of breastfeeding in mothers of premature newborns.

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
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Mothers of premature newborns, with birth weight ≤ 1750 g that have reached clinical stability defined by the medical staff.
  • To have signed an informed consent to participate in the study.

排除标准

  • Mothers that are HIV (Human Immunodeficiency Virus) positive.
  • Mothers of neonates with clinical problems that impaired breast suction (encephalopathy with serious hypotonus, oro-facial anomalies, and heart problems).
  • Mothers with severe hearing deficiencies.
  • Exit Criteria:
  • Mothers whose neonates died during the hospital stay.
  • Mothers who, for any reason, had three or less music therapy sessions.

结局指标

主要结局

Maternal Breastfeeding at Infant Discharge

时间窗: At the time of the infant hospital discharge

Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).

Maternal Breastfeeding 7-15 Days After Discharge

时间窗: At the first follow-up visit (7-15 days after discharge)

Maternal breastfeeding means: exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).

次要结局

  • Maternal Breastfeeding at 30 Days After Discharge(At 30 days after the infant hospital discharge)
  • Maternal Breastfeeding at 60 Days After Discharge(At 60 days after the infant hospital discharge)

研究者

申办方类型
Other

研究点 (2)

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