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临床试验/NCT04740762
NCT04740762已完成不适用

The Effectiveness of an Individual Counselling Program in Coping With Fear of Childbirth: A Randomized Controlled Study

Aydin Adnan Menderes University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年9月1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
70
试验地点
2
主要终点
Childbirth Self-Efficacy after intervention

研究概览

简要总结

A randomized control trial was made to developing an individual counseling program to help women cope with their fear of childbirth and testing the program for effectiveness.

详细描述

Fear of childbirth is a common problem among women and one that affects their health and welfare before and during pregnancy and in the postpartum period. The problem can lead to adverse pregnancy outcomes and also cause a woman to experience psychological issues. Fear of childbirth can also influence the determination of the mode of delivery and can amount to a rise in cesarean rates.

The healthcare provided by midwives and other healthcare professionals during pregnancy and childbirth have the power to reduce or exacerbate childbirth fears. The most significant midwifery intervention that can be used to diminish the fear of childbirth is counseling. There is a need to develop and test individual counseling models that require the basic training skills that midwives can use as part of their routine care to address women's fears and expectations about childbirth. The individual counseling program developed in this context may be an easy-to-implement and cost-effective method to use.

This study was conducted for the purposes of developing an individual counseling program to help women cope with their fear of childbirth and testing the program for effectiveness.

It was tested the hypotheses that there is no difference between the intervention and control groups of pregnant women after the intervention in terms of fear of childbirth, childbirth self-efficacy and state anxiety scores and childbirth outcomes (duration of labor, mode of delivery, elective and emergency cesarean rates, postpartum hypertension and need for a blood transfusion, the admittance of the newborn into the intensive care unit, preferences for future births and duration of stay in hospital).

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

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Primiparas
  • Ages between 18-35
  • Lived in Aydın
  • In gestational week 28-30,
  • Pregnant with a single child
  • Minimum a primary school graduate (since the questionnaires would be filled out by self-reporting)
  • In a low-risk pregnancy (on the basis of the criteria of the Ministry of Health),
  • Willing to divulge their own or their husband's telephone numbers,

排除标准

  • High-risk pregnancy who had psychological and mental health problems
  • History of infertility
  • Speech and hearing disabilities
  • Substance or narcotics users

结局指标

主要结局

Childbirth Self-Efficacy after intervention

时间窗: 36-38 gestational weeks

assessed using the Childbirth Self-efficacy Inventory-Short Form. The instrument measure levels of self-efficacy during labor. The scale is comprised of two subscales-outcome expectancies and self-efficacy expectancies. In the outcome expectancies subscale, responses range from 1: "not at all helpful" to 10: "very helpful," while in the self-efficacy expectancies subscale, the first 13 items are marked as 1: "Completely sure," to 10: "Not at all sure" and items 14-16 receive a score of 1: "Not at all sure" to 10: "Completely sure." All the responses to the inventory are based on a 10-point Likert-type scale. The lowest possible score on the Childbirth Self-efficacy Inventory is 32; the highest is 320. The higher the score, the more self-efficacy and confidence the pregnant woman has.

State Anxiety before intervention

时间窗: 28-30 gestational weeks

assessed using the State Anxiety Inventory. The instrument is composed of 20 items. The total possible score on the instrument varies between 20-80. The measurements according to the State Anxiety Inventory scores indicate no anxiety at a score of 0-19, moderate anxiety at 20-39, a high level of anxiety at 40-59, severe anxiety at 60-79 and panic-evoking anxiety at 80 and above.

Mode of Delivery

时间窗: 12th-24th hour after the birth

used to determine the mode of delivery. Mode of delivery was recorded by the researcher to the postpartum questionnaire as vaginal or cesarean section.

Elective and Emergency Cesarean Rates

时间窗: 12th-24th hour after the birth

used to determine the elective and emergency cesarean rates. Elective and emergency cesarean rates were recorded by the researcher to postpartum questionnaires as yes or no from hospital record.

Fear of childbirth after birth

时间窗: 12th-24th hour after the birth

assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version B. This instrument contains questions on women's postpartum experiences to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel after their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version-B is based on a 6-point Likert scale where the responses are numbered from 1-6 and one corresponds to the response, "Totally" and six means "none." The total possible score on the scale varies between 33-198. Higher scores indicate greater levels of Fear of Childbirth.

Fear of childbirth before intervention

时间窗: 28-30 gestational weeks

assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version A. This instrument contains questions on women's prenatal expectations to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel before their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version A is based on a 6-point Likert scale numbered 0-5. Zero corresponds to the response, "Totally" and five means "none." The minimum possible score on the scale is a "0"; maximum is 165. Higher scores indicate greater levels of Fear of Childbirth.

Childbirth Self-Efficacy before intervention

时间窗: 28-30 gestational weeks

assessed using the Childbirth Self-efficacy Inventory-Short Form. The instrument measure levels of self-efficacy during labor. The scale is comprised of two subscales-outcome expectancies and self-efficacy expectancies. In the outcome expectancies subscale, responses range from 1: "not at all helpful" to 10: "very helpful," while in the self-efficacy expectancies subscale, the first 13 items are marked as 1: "Completely sure," to 10: "Not at all sure" and items 14-16 receive a score of 1: "Not at all sure" to 10: "Completely sure." All the responses to the inventory are based on a 10-point Likert-type scale. The lowest possible score on the Childbirth Self-efficacy Inventory is 32; the highest is 320. The higher the score, the more self-efficacy and confidence the pregnant woman has.

Fear of childbirth after intervention

时间窗: 36-38 gestational weeks

assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version A. This instrument contains questions on women's prenatal expectations to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel before their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version A is based on a 6-point Likert scale numbered 0-5. Zero corresponds to the response, "Totally" and five means "none." The minimum possible score on the scale is a "0"; maximum is 165. Higher scores indicate greater levels of Fear of Childbirth.

State Anxiety after intervention

时间窗: 36-38 gestational weeks

assessed using the Childbirth Self-efficacy Inventory-Short Form. The instrument measure levels of self-efficacy during labor. The scale is comprised of two subscales-outcome expectancies and self-efficacy expectancies. In the outcome expectancies subscale, responses range from 1: "not at all helpful" to 10: "very helpful," while in the self-efficacy expectancies subscale, the first 13 items are marked as 1: "Completely sure," to 10: "Not at all sure" and items 14-16 receive a score of 1: "Not at all sure" to 10: "Completely sure." All the responses to the inventory are based on a 10-point Likert-type scale. The lowest possible score on the Childbirth Self-efficacy Inventory is 32; the highest is 320. The higher the score, the more self-efficacy and confidence the pregnant woman has.

Duration of labor

时间窗: 12th-24th hour after the birth

used to determine the duration of labor. Duration of labor was recorded by the researcher to postpartum questionnaire as hours from hospital record.

次要结局

  • Preferences for Future Births(12th-24th hour after the birth)
  • Postpartum hypertension(12th-24th hour after the birth)
  • Admittance of the Newborn into the Intensive Care Unit(12th-24th hour after the birth)
  • Need for a blood transfusion(12th-24th hour after the 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

Gizem Öztürk

Research Assistant

Aydin Adnan Menderes University

研究点 (2)

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