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临床试验/NCT04104009
NCT04104009Unknown不适用

The Relation Between Midwifery Education of Pregnant Women and Listening to Classical Music With the Mode of Delivery, the Length of Breastfeeding and the Incidence of Psychic Symptoms: RCT

University of Mostar2 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2019年1月1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
198
试验地点
2
主要终点
Delivery Mode

研究概览

简要总结

The emotional and psychological well-being of women influence the perception and experience of pregnancy and childbirth. Pregnant women with a fear of childbirth are more likely to give birth by caesarean section. An increased risk of obstetric interventions such as planned and emergency caesarean section has been determined. Childbirth education is an intervention that has a major impact on maternity outcomes and birth experience

详细描述

The emotional and psychological well-being of women significantly affects the perception and experience of pregnancy and childbirth. Pregnant women with a fear of childbirth are more likely to give birth by caesarean section. An increased risk of obstetric interventions such as planned and emergency caesarean section was also identified. Childbirth education is an intervention that has a great impact on birth outcomes and childbirth experiences.

A Cochrane systematic review found that the effects of antenatal education on childbirth and parenting are quite unknown. In a longitudinal cohort study, on a sample of 576 women, Bossano et al. investigated the impact of the vaginal birth method and the experience experienced on health after a decade. It was found that women with caesarean section were significantly more distressed than those who had delivered vaginally, and that the experience of childbirth remains in the memory even after a decade.

A randomized controlled study conducted in Australia by Fenwick et al. divided a sample of 339 pregnant women into a test and control group measured the impact of midwifery education on outcomes in childbirth, breastfeeding and the development of postpartum depression. Pregnant women of the interventional group received individual psychoeducation training by midwives in the second trimester of pregnancy. The control group did not undergo individual training. Finally, 184 female respondents with duly completed questionnaires were included in the analysis. In comparison with the control group, the caesarean section rate in the interventional was clinically but not statistically significantly lower (by 8%), and the need for an emergency caesarean section in the test group was less than 7%. There was no difference in the assessment of postpartum depression between the two groups. At 6 weeks postpartum, there was no statistically significant difference in the infant's diet between the two groups. In the interventional group, 83.5% were breastfed and 78.5% in the control group. It was concluded that the psychoeducation of pregnant women had the effect of reducing the overall rate of caesarean section. The impact of education on psychosocial health was found in a randomized controlled study called "Mindfulness - based program on the psychological health of pregnant women" in a sample of 104 women, divided into an interventional and control group. Pregnant women in the interventional group attended an eight-week program in groups between 13 and 26 weeks of gestation and used audio recordings at home, and had statistically significantly lower levels of stress and depression compared to the control group when measured at 36 weeks of gestation.

The use of deep inhalation and exhalation breathing exercises has proven effective in reducing the perception of pain in childbirth. A randomized clinical trial by Yuksel et al. in a sample of 250 pregnant women divided into test and control groups, the aim was to determine the effectiveness of the exercise on the perception of pain and the impact on the Apgar score of the infant after 1 minute. Pregnant women underwent a series of exercise training sessions and practiced during the first delivery phase to reduce stress and relaxation. There was a statistically significant difference in the lower perception of pain in the interventional group compared to the control group. A VAS scale of pain was used to assess pain. There was no statistically significant difference in the value of the Apgar score.

The therapeutic effects of listening to music on maternal and infant health have been proven in numerous studies. A lower incidence of anxiety and depression in women, a lower perception of pain during childbirth, a higher oxygen saturation in a newborn infant, and longer breastfeeding were found. A unique package with selected music has not been defined, but the choice is left to the creativity and knowledge of health professionals. A statistically significantly lower level of pain and anxiety at all measured time intervals was determined by a study in which a test group of 80 first-timers listened to music of their choice during childbirth compared to a control group who underwent childbirth without listening to music.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women
  • Territory of Herceg-Bosna County
  • Monitoring pregnancy in the competent Health Centers and private gynecological surgeries

排除标准

  • Minor pregnant women
  • Pregnant women in the first trimester of pregnancy
  • Pregnant women after the 34th week of gestation
  • Multiple pregnancies
  • Pregnant women having a cesarean delivery in their anamnesis
  • Pregnant women with psychiatric diagnosis
  • Pregnancies at-risk
  • Incomplete or illegally filled questionnaires
  • Pregnant women who did not listen to classical music the agreed way
  • Delivery of a stillborn baby

研究组 & 干预措施

Interventional group

Experimental

In the exam group there will be group training for four meetings of one hour each.

After completing the training program with the test group, a break of 5 weeks will follow, during which a new test and control group will be formed. The procedure will be carried out until the estimated sample size (99 subjects per group) is met.

干预措施: Education (Other)

Control group

Active Comparator

In the control group there will not be any group training.

干预措施: No education (Other)

结局指标

主要结局

Delivery Mode

时间窗: up to 10 months

caesarean section or vaginal birth

次要结局

  • Psychic symptoms(up to 10 months)
  • Apgar score(up to 10 months)
  • Pain score(up to 10 months)
  • Breastfeeding(up to 10 months)

研究者

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

Roberta Perkovic

Head nurse of the department of women's diseases and childbirth

University of Mostar

研究点 (2)

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