Music During Labor and Delivery: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- pain during the active phase
研究概览
简要总结
The use of music is widely supported in various areas of medicine: first of all in the psychiatric field as in the treatment of autism in children, obtaining surprising results even on Alzheimer's patients, or the unparalleled effect of music on those suffering from depression. To strengthen the thesis of the usefulness of music in medicine there is what is called PNEI, or the psychoneuroendocrinoimmunology. This discipline consists in the study of mutual interactions between mental activity, behavior, nervous system, endocrine system and immune reactivity. The PNEI itself no longer pays attention to the mind with respect to the body, but using the principles of the empirical epistemology of the scientific method strives to clarify those connections that make the nervous system, mind, immunity and hormonal regulation a unique and complex homeostatic control system of the individual, whose synergism would be able to modify certain biological behaviors, such as the transition from a distress to an eustress. This passage would seem to be of particular obstetric interest going to significantly change the course of labor in terms of pain, anxiety and well-being of women. In fact, many women prefer not to resort to partoanalgesia and famaci for pain control during labor.
A recent Cochrane Review analyzed the effectiveness of music in the control of pain in labor, confirming its role in this sense. However, he concluded that the quality of available evidence varied from low to very low, thus highlighting the need for further studies in this area.
Thus, the present study arises with the rational to satisfy this need for further investigation into the positive effects of music on pain in women in labor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •singleton gestations;
- •term of phisiological pregnancy
- •spontaneous labor
- •diagnosis of active phase of labor;
- •nulliparous between 37 and 42 gestation weeks with cephalic presentation ;
- •maternal age between 18 and 45 years.
排除标准
- •multiple gestations;
- •preterm labor;
- •preterm premature rupture of membranes
- •induction to delivery labor;
- •Hipertensive disorders;
- •fetal abnormalities;
- •diabetes mellitus;
- •intrauterine growth retardation;
- •post-term pregnancy;
- •multiple vaginal delivery;
- •women with an altered state of consciousness, severely ill, mentally disabled;
- •women who are unconscious, severly ill, mentally handicapped;
- •women under the age of 18 years or over the age of 45 years.
结局指标
主要结局
pain during the active phase
时间窗: during the labor
pain assessed with VAS
次要结局
- pain during second stage, and during postpartum(during the labor)
- anxiety during the active phase, second stage, and postpartum(during the labor)
- neonatal outcomes(at the time of delivery until 28days of life)
- episiotomy and lacerations(at the time of delivery)
- labor length(during labor)
- postpartum depression(at the time of delivery)
- analgesia(at the time of delivery)
研究者
Gabriele Saccone
Principal Investigator
Federico II University