Simulation in Shoulder Dystocia Management

NCT ID: NCT07009626

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-05-28

Brief Summary

Shoulder dystocia is an unpredictable and unpredictable emergency obstetric condition that causes serious maternal and neonatal complications. Therefore, it requires immediate and effective intervention. It is known as the condition in which the shoulders cannot be released from the pelvis and remain stuck after the fetal head is born during delivery. Fetal macrosomia is shown as the most important risk factor for shoulder dystocia. The intervention to be performed for shoulder dystocia should start from the least invasive and progress to the more invasive. Detection and management of shoulder dystocia requires sufficient technical knowledge, skills and experience. Simulation-based learning in midwifery education and practice provides students with the opportunity to manage and develop skills in many risky situations close to reality outside the hospital environment. In addition, the fact that the application can be repeated many times without harming people also affects the anxiety and self-efficacy levels of students before real clinical experience. As a result, it is understood that shoulder dystocia is an important condition that cannot be predicted and prevented, has very serious maternal and neonatal consequences, and a systematic approach should be used in its prevention, early diagnosis and management. The aim of this study is to evaluate the effect of a computer-based simulation training model on the knowledge level, management skills and anxiety levels of midwifery students about shoulder dystocia. The study will be conducted with all students enrolled in the "Risky Birth and Postpartum Period" course at the Department of Midwifery, Faculty of Health Sciences, Sakarya University in the 2024-2025 academic year. Data in the study will be collected through the Student Identification Form, Shoulder Dystocia and Management Information Form, Shoulder Dystocia Management Individual Assessment Form and Shoulder Dystocia Management Skills Assessment Form. The analysis of the data obtained from the study will be done with the SPSS program. It is thought that the study will make a significant contribution to the literature in terms of evaluating the effect of the computer-based simulation training model on shoulder dystocia management.

Detailed Description

Shoulder dystocia is defined as failure to deliver the shoulders after the delivery of the fetal head. This condition may occur as a result of a mismatch between the fetal shoulder size and the pelvic inlet, and may develop as an anterior or posterior shoulder attachment, or it may be seen in both shoulders. This condition is an unpredictable and unavoidable obstetric emergency, occurring in 0.6% to 1.4% of births. Shoulder dystocia usually includes risk factors such as maternal obesity, fetal macrosomia, maternal diabetes, prolonged labor, advanced age, use of epidural anesthesia, and a history of dystocia in previous births. Transient brachial plexus injury (BPI) is the most common fetal complication due to shoulder dystocia. Other fetal complications include clavicle and humerus injuries, permanent BPI, hypoxic ischemic encephalopathy and death. Maternal complications can lead to vaginal and cervical lacerations, postpartum hemorrhage, II.-III.-IV. degree perineal tears, and even late-term fistulas. Therefore, it is vital to know the risk factors in advance and to ensure the order of maneuvers to be performed and the correct application skills for difficult births that occur. Simulation education has been used in the health field for many years. Simulators help with rapid critical thinking and management of situations that cause confusion. In skill-based midwifery education, simulation-based learning focuses on many risky situations such as postpartum hemorrhage, shoulder impingement, and emergency breech delivery. The use of computer-based simulators allows students to practice and develop their skills in an environment that is almost like a hospital before going to hospital practice. Computer-based simulators are quite educational for students because they provide opportunities for realistic errors and realistic error attempts. Simulators are also known to increase learning satisfaction, improve communication skills and increase self-efficacy. In this study, it was aimed to evaluate the effect of the computer-based simulation training model on the knowledge level, management skills and anxiety levels of midwifery students about shoulder dystocia.

Conditions

Shoulder Dystocia; Simulation Based Medical Education; Midwifery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control group

Control group: The instructor will position the pelvic mannequin so that the fetus is in vertex presentation. A person independent of the research and training will facilitate the descent of the baby into the pelvic mannequin. After the delivery of the baby's head, the baby's descent will be stopped and the instructor will not allow the baby to be born. Each student will be given the opportunity to practice the process on the mannequin according to the steps of shoulder dystocia management. Each practice session will last approximately 10 minutes. The researcher will observe each student and provide feedback on their performance, including discussion of any errors made.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Computer-based high-validity birth simulator group

Computer-based high-validity birth simulator group: The instructor will place the fetus in a computer-based full-body birthing manikin in vertex presentation. In addition, the pregnant woman will be vocalized to increase realism and the patient's vital signs, fetal heart rate, etc. will be displayed on the patient monitor. The same scenario will be initiated for each student in the simulation group. Each student will be given the opportunity to practice the process on the simulation model in accordance with the shoulder dystocia delivery management steps. Each practice session will last 15-20 minutes. The researcher will observe each student and provide feedback on their performance, including discussion of any errors made.

Group Type: EXPERIMENTAL

Computer-based high-validity birth simulator

Intervention Type: OTHER

Computer-based high-validity birth simulator: All students in the intervention group underwent the same scenario of birth. Initially, the aim was to diagnose shoulder dystocia by ensuring that the shoulders were not delivered after the fetal head was delivered.

Interventions

Computer-based high-validity birth simulator

Computer-based high-validity birth simulator: All students in the intervention group underwent the same scenario of birth. Initially, the aim was to diagnose shoulder dystocia by ensuring that the shoulders were not delivered after the fetal head was delivered.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Registered in the midwifery department,
• Attending the risky birth and postpartum period course,
• Agreeing to participate in the study

Exclusion Criteria

• Those who have previously taken the risky birth and postpartum period course and failed the course,
• Those who did not attend the shoulder dystocia management course,

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

yasemin hamlacı başkaya

Assoc. prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasemin Hamlacı Başkaya

Role: PRINCIPAL_INVESTIGATOR

Sakarya University

Locations

Sakarya University

Sakarya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

PMID: 24863026 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 29381590 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 32667171 (View on PubMed)

Hill MG, Cohen WR. Shoulder dystocia: prediction and management. Womens Health (Lond). 2016;12(2):251-61. doi: 10.2217/whe.15.103. Epub 2016 Feb 22.

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 34840738 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 30882355 (View on PubMed)

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Reference Type: BACKGROUND

Other Identifiers

28052025

Identifier Type: -

Identifier Source: org_study_id