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临床试验/NCT05216783
NCT05216783已完成不适用

Effect of Motivational Interviews on Childbirth Perception and Childbirth Self-Efficacy: A Randomized-Controlled Trial

Inonu University1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2019年11月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
166
试验地点
1
主要终点
Traumatic Childbirth Perception Scale (TCPS)

研究概览

简要总结

Aim: The aim of this study to determine the effect of motivational interviews on the perception and self-efficacy of birth in nullipars with a perception of traumatic birth.

Materials and Methods: The study was conducted in a randomized controlled, between November 2019 and November 2020 in the obstetrics outpatient clinics of Elazig Fethi Sekin City Hospital. In the power analysis, the sample size was calculated as at least 83 pregnant women for each group (83 experiment, 83 control). Data were collected with Descriptive Information Form, Traumatic Childbirth Perceptions Scale (TCPS) and Childbirth of Self-Efficacy Scale-Short From (CBSE). Pregnant women in the experimental group were held with four sessions of motivational interviews one week a part. No intervention was made for the pregnant women in the control group. Descriptive statistics, chi-square test, t test for dependent and independent groups were used in data analysis

详细描述

Materials and Methods

Research Design and Sample

This study was designed as a randomized controlled trial in which the research subjects were randomly assigned to an experimental group that took part in the motivational interview and a control group. The research population was comprised of nulliparous women who were admitted to the obstetrics polyclinic in a city hospital in Turkey. Only a city hospital and a university hospital were located in the province center where the research took place. Mostly, the high-risk pregnancies are followed up in the university hospital. Therefore, the research was conducted in the city hospital. According to the records of the city hospital, 6,768 pregnant women were admitted to the obstetrics polyclinic in 2019. The research data were collected from July 2019 to November 2020.

Web-based sample size calculation was used in calculating the sample size for the research. As per the power analysis conducted with a 5% margin of error, 95% confidence interval at two-tailed statistical significance level, and 80% power, the sample size was calculated as 83 pregnant women for each group (83 pregnant women for the experimental group, 83 pregnant women for the control group) assuming that the mean Traumatic Childbirth Perception Scale score that was 70.57±21.89 points before applying the motivational interviews (Aktaş, 2018) would go down by 9 points following the motivational interviews. The process of sample selection took place in conformity with the criteria prescribed by the Consolidated Standards of Reporting Trials (CONSORT).

The criteria for being included in the research were as follows: (1) having the ability to communicate, (2) being within 28-36 weeks of pregnancy, (3) being aged 18 or above, (4) having a live singleton fetus, (5) having no pregnancy-related risk (pre-eclampsia, diabetes, cardiac disease, placenta previa, oligohydramnios, and so on), (6) having no problem about the fetus's health (fetal anomaly, intrauterine growth restriction, and so on), (7) having a medium or a higher level of traumatic childbirth perception according to the Traumatic Childbirth Perception Scale (≥53 points). The criterion for being excluded from the research was to have a condition that would prevent the woman from having a normal birth (total placenta previa and so on).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
28 Weeks 至 36 Weeks(Child)
性别
Female
接受健康志愿者
是

入选标准

  • •having the ability to communicate,
  • •being within 28-36 weeks of pregnancy,
  • •being aged 18 or above,
  • •having a live singleton fetus,
  • •having no pregnancy-related risk (pre-eclampsia, diabetes, cardiac disease, placenta previa, oligohydramnios, and so on),
  • •having no problem about the fetus's health (fetal anomaly, intrauterine growth restriction, and so on),
  • •having a medium or a higher level of traumatic childbirth perception according to the Traumatic Childbirth Perception Scale (≥53 points).

排除标准

  • •The criterion for being excluded from the research was to have a condition that would prevent the woman from having a normal birth

研究组 & 干预措施

Experimental

Experimental

The Personal Information Form, the Traumatic Childbirth Perception Scale (TCPS), and the short-form Childbirth Self-Efficacy Inventory (CBSEI-32) were utilized for the collection of research data. First of all, the TCPS was applied to the pregnant women, and the pregnant women who obtained a score above 53 points (moderate-level traumatic childbirth perception) from the TCPS were invited to the research. Next, the Personal Information Form and the CBSEI-32 were applied to the pregnant women who agreed to participate in the research. The motivational interviews were held with the pregnant women in the experimental group once a week for four weeks. No initiative was applied to the pregnant women in the control group. The TCPS and CBSEI-32 were applied to all participant pregnant women after four weeks following the first application. The application of the measurement tools took 10-15 minutes.

干预措施: Motivational Interviews (Behavioral)

Control

No Intervention

The researchers applied no initiative to the control group, and the pregnant women in the control group solely had the routine checks performed at the city hospital. At the end of the study, the questions of pregnant women in the cotrol group about childbirth were answered. Before applying the initiative to the experimental group, the researcher (SB) had had training about motivational interview techniques.

结局指标

主要结局

Traumatic Childbirth Perception Scale (TCPS)

时间窗: Change from Traumatic Childbirth Perception at 4 weeks

It is used to evaluate the traumatic childbirth perception levels of the women at reproductive age. The scale has a total of 13 questions that cover thoughts and emotions such as anxiety, fear, and worry felt by the women while thinking about the concept of childbirth. Each question is scored from 0 (I am not afraid at all) to 10 points (I am very afraid). The mean of scores obtained from the scale indicates the traumatic childbirth perception level. The minimum and maximum scores to be obtained from the scale are successively 0 and 130 points. A high score obtained from the scale demonstrates that the pregnant woman has high-level traumatic childbirth perception. The scores ranging from 0 to 26, from 27 to 52, from 53 to 78, from 79 to 104, and from 105 to 130 consecutively refer to very low, low, moderate, high, and very high levels of traumatic childbirth perception

次要结局

  • Short-Form Childbirth Self-Efficacy Inventory (CBSEI-32)(Change from Short-Form Childbirth Self-Efficacy at 4 weeks)

研究者

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

Sümeyye Barut

Lecturer

Inonu University

研究点 (1)

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