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Simulation Techniques Used in Breech Birth Management Training

Primary Purpose

Breech Presentation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
simulation
Sponsored by
Sakarya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breech Presentation focused on measuring breech birth, simulation, midwifery students, training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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 3. Students who agreed to take part in the study Exclusion Criteria: Students who failed in the High-Risk Birth Management course Students who did not participate in theoretical education of breech birth management

Sites / Locations

  • Sakarya University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Pelvic simulator group (PSG)

Computer-based simulator group (CBSG)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

State-Trait Anxiety Inventory Score Change
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
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
March 31, 2023
Last Updated
May 8, 2023
Sponsor
Sakarya University
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1. Study Identification

Unique Protocol Identification Number
NCT05827627
Brief Title
Simulation Techniques Used in Breech Birth Management Training
Official Title
Assessment of Efficacy of Two Different Simulation Techniques Used in Breech Birth Management Training: A Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2019 (Actual)
Primary Completion Date
January 10, 2020 (Actual)
Study Completion Date
January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sakarya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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?"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Presentation
Keywords
breech birth, simulation, midwifery students, training

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was conducted in two groups: a pelvic simulator group (PSG) and a computer-based simulator group (CBSG).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic simulator group (PSG)
Arm Type
Other
Arm Description
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.
Arm Title
Computer-based simulator group (CBSG)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
simulation
Intervention Description
Midwifery student directing the birth of a fetus with frank breech presentation.
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory Score Change
Description
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.
Time Frame
pre-intervention, 1 hour after intervention
Title
Self-Efficacy Scale Score Change
Description
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.
Time Frame
pre-intervention, 1 hour after intervention
Title
Breech Birth Management Information Form Score Change
Description
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.
Time Frame
pre-intervention, 1 hour after intervention
Title
Breech Birth Management Skill Assessment Form
Description
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.
Time Frame
1 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 3. Students who agreed to take part in the study Exclusion Criteria: Students who failed in the High-Risk Birth Management course Students who did not participate in theoretical education of breech birth management
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasemin Hamlacı Başkaya
Organizational Affiliation
Sakarya University
Official's Role
Study Director
Facility Information:
Facility Name
Sakarya University
City
Sakarya
ZIP/Postal Code
54200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20693215
Citation
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Results Reference
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Results Reference
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Citation
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Citation
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Citation
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Citation
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Citation
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Simulation Techniques Used in Breech Birth Management Training

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