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临床试验/NCT05827627
NCT05827627已完成不适用

Assessment of Efficacy of Two Different Simulation Techniques Used in Breech Birth Management Training: A Randomised Controlled Study

Sakarya University1 个研究点 分布在 1 个国家实际入组 75 人开始时间: 2019年11月10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
发起方
入组人数
75
试验地点
1
主要终点
State-Trait Anxiety Inventory Score Change

研究概览

简要总结

This study was conducted to assess the effect of two different simulation techniques that are used to improve breech birth management skills of midwifery students on the anxiety, self-efficacy, skill and knowledge levels of students.

详细描述

Professional midwives are an integral part of delivering quality sexual, reproductive, maternal, and newborn healthcare. Midwives must have the skills and knowledge to assist childbirth and identify problems when labour progresses well. When a midwife examines a woman in labour, she may encounter an unexpected breech presentation. Therefore, it is important for midwives to have the skills and knowledge to deliver breech babies and assist mother and baby. Recently, caesarean section has been preferred in breech presentations. However, if breech presentation is diagnosed after the active phase, there may not be enough time for preparations for caesarean section, or the woman may refuse surgical intervention. In both cases, the midwife who examines the woman should inform the obstetrician immediately and, if possible, seek the assistance of another midwife or physician who is experienced in vaginal breech delivery in the management of childbirth. This may result in foetal injury at the hands of inexperienced providers. Midwives and physicians providing intrapartum care must have good training on breech birth manoeuvres and management of the second phase in order to minimise complications. Furthermore, one of the competencies specified by the International Confederation of Midwives (ICM) in midwifery practices is to 'Undertake appropriate manoeuvres and use maternal position to facilitate vertex, face, or breech birth'. Many midwifery education programmes now use various simulators and simulation training to improve the skills of students in high-risk deliveries.

Simulation-based training is an educational method bridging theory and practice and is one of the preferred skill training methods at educational institutions for healthcare professionals. Reasons for preferring this method can be listed as: limited access of students to a qualified faculty in clinical settings, low frequency of situations and limited exposure to actual patients. There are also ethical reasons for using simulation in the education of students, such as minimising risks for patients and providing students with an opportunity to learn through simulation. Simulation training provided before clinical practice helps students to feel safe and well prepared for the clinical setting. Having repetitive training in a safe and secure environment without fear of comprising patient safety is viewed as important for students.

There has been growing interest in simulation and skill training in midwifery education. Simulation laboratories have been established at many universities and training hospitals. The most commonly used simulation types in midwifery education are scenario-based skill training with standardised patients, scenario-based high-technology simulators, and simulators not involving technological design (e.g., episiotomy simulators, pelvic simulators for childbirth, simulator dolls). In midwifery education, it is aimed to teach students basic and advanced practice skills, such as delivering a certain number of babies, making and repairing episiotomies and assisting breech births. Simulation-based learning develops professional competence in midwifery educators as well as equipping and empowering midwifery students regarding practices. In undergraduate midwifery education, students are provided with obstetric skill training in electronic foetal monitoring (EFM), childbirth management, shoulder dystocia, postpartum haemorrhage, breech birth, umbilical cord prolapse and perineal repair (laceration and episiotomy). It has been determined that simulation-based training affected positively participants' perceived readiness. Training provided with high-fidelity, high-technology simulators has been determined to enhance students' self-efficacy, confidence and satisfaction.

It has been aimed to find answers of "is there any difference in students' levels of anxiety, self-efficacy and knowledge on breech birth management between a pelvic simulator group and a computer-based simulator group before and after the training?" and "is there any difference in improving skills in breech birth management between the two groups?"

研究设计

研究类型
干预性
分配方式
随机
干预模型
平行分组
主要目的
卫生服务研究
盲法
开放(无盲法)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • Students who were enrolled in the senior year
  • Students who participated in the High-Risk Birth Management course
  • Students who received theoretical information on breech birth management
  • Students who agreed to take part in the study

排除标准

  • Students who failed in the High-Risk Birth Management course
  • Students who did not participate in theoretical education of breech birth management

研究组 & 干预措施

Pelvic simulator group (PSG)

Other

The trainer positioned the foetus in the pelvic simulator in frank breech presentation. Descent of the baby in the pelvic simulator was administered by a person independent of the study and the training.

干预措施: simulation (Other)

Computer-based simulator group (CBSG)

Experimental

The trainer positioned the foetus in the computer-based full-body childbirth simulator in frank breech presentation. The pregnancy simulator streamed audio to increase reality and the patient monitor displayed vital signs of the pregnant simulator and foetal heart rate.

干预措施: simulation (Other)

结局指标

主要结局

State-Trait Anxiety Inventory Score Change

时间窗: pre-intervention, 1 hour after intervention

The inventory, developed by Spielberger et al. (1970), is a self-evaluation questionnaire involving short evaluations (Spielberger et al., 1983). Its validity and reliability study in Turkey was conducted by Öner and Lecompte (1983) (Öner \& Le Compte, 1983). The inventory consists of two different questionnaires with 40 items in total. The STAI consists of 20 items that aim to assess how the individual feels at a specific time under specific conditions by considering their present feelings and was used in our study. It is a 4-point Likert scale ranging from 'Not at all' to 'Very much so'. The maximum score that can be obtained from the scale is 80, and the minimum score is 20. Higher scores are correlated with higher levels of anxiety.

Self-Efficacy Scale Score Change

时间窗: pre-intervention, 1 hour after intervention

Developed by Sherer et al. (1982), the Self-Efficacy Scale is a 5-point Likert scale and consists of 23 items (Gözüm \& Aksayan, 1999; Sherer et al., 1982). The scale measures generalised, non-specific perception of self-efficacy. The scores to be obtained from the scale range from 23 to 115; higher scores represent a good level of self-efficacy perception.

Breech Birth Management Information Form Score Change

时间窗: pre-intervention, 1 hour after intervention

This form was developed based on relevant literature (Marshall \& Raynor, 2014; Posner et al., 2013; Shuttler, 2018; Walker, Reading, et al., 2017). It consisted of 17 statements intended to measure the students' level of knowledge on breech birth management. The statements were prepared to include eight correct and nine incorrect statements which were answered by the participants as 'I agree', 'I disagree' or 'I have no idea'. One point was awarded for correct answers and zero points for incorrect and 'no idea' answers. Higher knowledge scores denote a higher level of knowledge on breech birth management.

Breech Birth Management Skill Assessment Form

时间窗: 1 hours

The Breech Birth Management Skill Assessment Form was prepared by reviewing the relevant literature (Hardy et al., 2020; Jordan et al., 2016; Shuttler, 2018; Walker, Breslin, et al., 2017). The form consisted of 19 items involving steps of breech birth management, such as hand washing, protecting privacy, making necessary explanations to the pregnant woman, determining the presentation of the foetus, informing the pregnant woman about pushing and cooperating, waiting for the umbilical cord to be delivered, assisting the delivery of the baby's arm and head with suitable manoeuvres, informing the woman about the outcomes, and recording the procedures on an observation sheet.The score to be obtained from the form ranged from 19 to 57.

次要结局

未报告次要终点

研究者

发起方
Sakarya University
申办方类型
其他
责任方
主要研究者
主要研究者

Yasemin Hamlaci Baskaya

Head of Midwifery Depatment

Sakarya University

研究点 (1)

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标识符

NCT 编号
NCT05827627
其他研究编号
03052019

日期

首次提交
(3年前)
首次发布
(3年前)
主要完成日期
(6年前)
研究完成日期
(6年前)
最近核实
(3年前)
最近更新
(3年前)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否
是否有结果
否

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