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临床试验/NCT04838340
NCT04838340已完成不适用

Effect of Hypnobirthing Training on Fear, Pain, Satisfaction Related to Birth and, Birth Outcomes: A Randomized Controlled Trial

Aydin Adnan Menderes University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Preinterventional Scores on the W-DEQ-A (the minimum values:0, maximum:165)

研究概览

简要总结

Background and Purpose: Hypnobirthing is childbirth education model. This model aims for women to have a painless, calm and more comfortable birth. In this study is aimed to determine the effect of Hypnobirthing training on fear of childbirth, birth pain, birth satisfaction and birth outcomes.

Materials and Methods: This randomized controlled experimental study was performed in Maternity Hospital (Bursa, Turkey) . The minimum required sample size to be included in the study will calculated with G* power. The simple randomization method was use in the assignment of healthy and nulliparous pregnant women at 28-32 weeks of gestation to the groups. The assignment of the participants to the experimental group or control group was carried out with a computer-aided program. The nulliparous women was divided into two groups as the control group contained women who received the hospital's usual care, and the experimental group contained women who received the hypnobirthing training intervention. The fear of birth was measured with the Wijma Birth Expectancy/Experience Scale A and B (W-DEQ); labor pain was measured with Visual Analogue Scale (VAS); birth satisfaction was measured with Short Form of Birth Satisfaction Scale (BSS-R); birth outcomes will measure with postpartum Information form. The Statistical Package for the Social Sciences program (version 25.00) was use in data analysis.

详细描述

Fear of childbirth and labor pain are big problem that needs to be resolved as a priority since this situation continues by starting the vicious cycle of fear-anxiety-pain during childbirth. The persistence of the cycle increases the fear and pain related to childbirth, and thus delivery may result in emergency cesarean or elective cesarean. According to the data of Economic Development and Cooperation (OECD), the cesarean section rate in Turkey is 53.1% and so higher than the recommended rate, even Turkey has the highest rate among the OECD countries . High cesarean rates are an important problem that negatively affects maternal and infant health and increase health expenditures and costs. Therefore, the pregnant women education programs aimed at lowering the rate of cesarean section are still important in Turkey as in other countries. While the childbirth education programs for pregnant women are not widely practiced in Turkey, the Turkish Ministry of Health (TMOH) started to provide childbirth preparation courses to reduce the rate of cesarean section in recent years. In the circular issued by the TMOH in 2018, it was determined that these programs should be managed by physicians, obstetrics nurses, and midwives. Nurses are actively involved in pregnancy training programs where different methods are applied in Turkey as well as all over the world. The most common training methods applied in other countries are Lamaze Method, Bradly Method, and Hypnobirthing.

Hypnobirthing is a childbirth preparation method that aims to prepare pregnant women for delivery mentally and physically and to give birth in a less painful, conscious, and fear-free way. This method was developed based on the fear-stress-pain cycle. The persistence of this cycle exacerbates stress and pain, prolongs the birth period, and negatively affects the success, way, preference, course, and satisfaction of the birth. Thus, the birth does not proceed properly and results in an emergency or elective cesarean section. Hypnobirthing can prepare women for childbirth to eliminate all these negativities.

Hypnobirthing training can be considered as a new technique for Turkey and therefore we conducted this study to determine its effects on the pain, fear, satisfaction related to childbirth and childbirth outcomes.

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 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Primiparas
  • Ages between 18-42
  • In gestational week 28-32
  • Being literate in Turkish
  • Pregnant with a single child
  • Minimum a primary school graduate (since the questionnaires would be filled out by self-reporting)

排除标准

  • High-risk pregnancy (on the basis of the criteria of the Ministry of Health)
  • Attended other prenatal training sessions (pregnancy pilates and yoga)
  • High-risk pregnancy

结局指标

主要结局

Preinterventional Scores on the W-DEQ-A (the minimum values:0, maximum:165)

时间窗: When the control and experimental groups were Enrollment in the study

Distribution of the scores of pregnant women on the W-DEQ-A before the intervention to the experimental and control groups. Higher scores are worse outcome.

W-DEQ-B Scores (the minimum values:0, maximum:160)

时间窗: within eight hours after birth

Distribution of the scores of the women on the whole W-DEQ-B according to the control and experimental groups. Higher scores are worse outcome.

The chilbirth scores of the experimental and control groups (questionnaire)

时间窗: within eight hours after birth

Information about the childbirth of the experimental and control groups ( childbirth position, Intervention at birth, way of delivery, duration of delivery)

The VAS scores of the experimental and control groups (the minimum values:0, maximum=10)

时间窗: in the process of labor (the first stage of labor: latent, active and transitional phases )

Distribution of the women on the VAS in the first stage of labor according to the experimental and control groups. Higher scores are worse outcome.

BSS-R scores of experimental and control groups (the minimum values:0, maximum:40) • Low level of satisfaction ˂13 points, • Medium satisfaction level 14-27 points, • High satisfaction level ≥28

时间窗: within eight hours after birth

Postpartum scores of the control and experimental groups on the BSS-R. Higher scores are better outcome.

次要结局

  • Women and baby interaction(within eight hours after birth)

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gonca Buran

Principal Investigator

Aydin Adnan Menderes University

研究点 (2)

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