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Completed

NCT Number: NCT07009626

Simulation in Shoulder Dystocia Management

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.

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Key information

Conditions

Shoulder Dystocia Anxiety Disorders Dystocia Female Urogenital Diseases and Pregnancy Complications Mental Disorders Midwifery Obstetric Labor Complications Pregnancy Complications Simulation Based Medical Education Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya University

Sakarya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Computer-based high-validity birth simulator

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.

Primary outcomes

  1. Shoulder Dystocia and Management Information Form

    Time frame: pre-intervention, 1 hour after intervention

    This is a questionnaire form developed by researchers in line with the information in the guide developed by RCOG for the management of shoulder dystocia. This form, which will be applied before and after the training, consists of 18 questions. It was used to determine the knowledge levels of students about shoulder dystocia and its management. One point was given for each correct answer given to the questions in the survey. The maximum total score that can be obtained is 18. Students will mark the questions in the shoulder dystocia and its management information form as true, false or I have no idea.

  2. State Anxiety Inventory

    Time frame: pre-intervention, 1 hour after intervention

    The inventory developed by Spielberger and colleagues (1970) is a self-assessment questionnaire consisting of short assessments (Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983). The validity and reliability of the inventory in Turkey was conducted by Öner and Lecompte (1983) (Öner & Le Compte, 1983). The State Anxiety Inventory consists of 20 items and requires the individual to answer how he/she feels at a certain moment and under certain conditions, taking into account his/her feelings about the situation he/she is in. The scale is a Likert-type scale with four points ranging from "Not at all" to "Completely". High scores indicate a high level of anxiety, and low scores indicate a low level of anxiety. In the validity and reliability study of the inventory, the Cronbach Alpha coefficient for the SAI was between 0.94 and 0.96 (Öner & Le Compte, 1983).

  3. Shoulder Dystocia Management Skills Assessment Form

    Time frame: 1 hours

    It is a form that evaluates students' implementation of the steps in shoulder dystocia management.

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

Effectiveness of Simulation in Shoulder Dystocia Management Education: A Randomized-Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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