Clinical trial NCT07009626: Simulation in Shoulder Dystocia Management
Official title: Effectiveness of Simulation in Shoulder Dystocia Management Education: A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dystocia
Simulation Based Medical Education
Midwifery
Keywords: shoulder dystocia
simulation
midwifery education
anxiety
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 (Beşevli and Hüseyinoğlu, 2024; Şenoğlu and Karaçam, 2019). 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 (Behram and Eyi, 2021). 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 (Gönenç and Sayıner, 2023). 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 (Çalım \& Öztürk, 2018). Simulators are also known to increase learning satisfaction, improve communication skills and increase self-efficacy (Nassar, Al-Manaseer, Knowlton, \& Tuma, 2021; Padilha et al., 2019). 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.

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,

Primary outcomes:
measure: Shoulder Dystocia and Management Information Form
timeFrame: pre-intervention, 1 hour after intervention
measure: State Anxiety Inventory
timeFrame: pre-intervention, 1 hour after intervention
measure: Shoulder Dystocia Management Skills Assessment Form
timeFrame: 1 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University
Study officials:
affiliation: Sakarya University
name: Yasemin Hamlacı Başkaya
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grobman WA. Shoulder dystocia: simulation and a team-centered protocol. Semin Perinatol. 2014 Jun;38(4):205-9. doi: 10.1053/j.semperi.2014.04.006.
citation: Gurewitsch Allen ED. Simulation of Shoulder Dystocia for Skill Acquisition and Competency Assessment: A Systematic Review and Gap Analysis. Simul Healthc. 2018 Aug;13(4):268-283. doi: 10.1097/SIH.0000000000000292.
citation: Hill DA, Lense J, Roepcke F. Shoulder Dystocia: Managing an Obstetric Emergency. Am Fam Physician. 2020 Jul 15;102(2):84-90.
citation: 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.
citation: Behram, M., ve Eyi, EGY. Vajinal Doğum Sırasında Omuz Distosisi Gelişen Olguların Değerlendirilmesi. Internatıonal Anatolıa Academıc Onlıne Journal, Health Scıences, 2021; 7(2), 109-118.
citation: Nassar AK, Al-Manaseer F, Knowlton LM, Tuma F. Virtual reality (VR) as a simulation modality for technical skills acquisition. Ann Med Surg (Lond). 2021 Oct 27;71:102945. doi: 10.1016/j.amsu.2021.102945. eCollection 2021 Nov.
citation: Padilha JM, Machado PP, Ribeiro A, Ramos J, Costa P. Clinical Virtual Simulation in Nursing Education: Randomized Controlled Trial. J Med Internet Res. 2019 Mar 18;21(3):e11529. doi: 10.2196/11529.
citation: Şenoğlu, A., ve Karaçam, Z. Omuz Distosisi: Ebelik Eğitim ve Uygulamalarındaki Yeri. Lokman Hekim Dergisi, 2019;9 (2): 147-159 DOI: 10.31020/mutftd.522365