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临床试验/NCT03348358
NCT03348358Unknown不适用

How do Different Genres of Music Played During Labor Effect the Stress Level and the Obstetric and Perinatal Results?

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2018年1月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
Objective stress

研究概览

简要总结

The purpose of this study is to randomize women to be exposed during labor to different genres of music and study the effect of each genre on the level of objective and subjective stress as manifested by salivary cortisol and personal stress questionnaires, respectively. Secondary outcomes to be examined are obstetric and perinatal outcomes

详细描述

For centuries, music has been known to have therapeutic effects on the body and the mind A large body of findings is related to the therapeutic potential of music in clinical settings, mainly among patients undergoing surgical and dental procedures, and also in other medical environments, such as intensive care, psychiatry, and geriatrics. Using music interventions in clinical settings was associated with reductions in negative effects in addition to objective stress and anxiety indices such as reduced heart rate, blood pressure, myocardial oxygen consumption, gastrointestinal function, anxiety, pain, and increased oxytocin levels.

One study found that women who listened to music before a cesarean section had a significant increase in positive emotions and a significant reduction in systolic blood pressure compared with a significant increase in diastolic blood pressure and respiratory rate in the control group. Li and Dong concluded in a different study, that preoperative music intervention can reduce anxiety and pain in women undergoing cesarean delivery.

Various studies examined the relation of music during labor to pain relief. One study found that the group of women going through music therapy had significantly lower pain, anxiety and a higher finger temperature during the latent phase of labor. One randomly assigned study found that women listened to soft music starting early in the active phase of labor had decreased sensation and distress of active labor pain. To date, no study examined the level of salivary cortisol while music is played at delivery room as an objective estimation of the stress level.

In addition to that, there is a lack of information regarding the effect of music during labor on the obstetric and perinatal outcomes.

Therefore, the purpose of this study is to randomize women to be exposed during labor to different genres of music and study the effect of each genre on the level of objective and subjective stress as manifested by salivary cortisol and personal stress questionnaire, respectively. Secondary outcomes to be examined are obstetric and perinatal outcomes.

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
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

入选标准

  • age 18-45
  • single embryo
  • term labor, >=37 weeks of gestation

排除标准

  • multiple embryos
  • Antepartum fetal death
  • preterm delivery

研究组 & 干预措施

control

Placebo Comparator

No music during labor

干预措施: control (Behavioral)

Quiet music

Experimental

Women hearing quiet music during labor

干预措施: quiet music (Behavioral)

Rhythmic music

Experimental

Women hearing rhythmic music during labor

干预措施: Rhythmic music (Behavioral)

结局指标

主要结局

Objective stress

时间窗: An hour after administration to delivery room

Stress as measured by saliva cortisol

Subjective stress

时间窗: An hour after administration to delivery room

Stress as measured by questionnaires

次要结局

  • Mode of delivery(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yael Pasternak

Principal Investigator

Meir Medical Center

研究点 (1)

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