NCT07009626

Simulation in Shoulder Dystocia Management

Completed NA Last updated 15 July 2025

What this trial tests

NA trial testing Computer-based high-validity birth simulator in Shoulder Dystocia in 87 participants. Completed in 28 May 2025.

Timeline

15 April 2025

Primary endpoint
15 May 2025

28 May 2025

Quick facts

Lead sponsor	Sakarya University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	87
Start date	15 April 2025
Primary completion	15 May 2025
Estimated completion	28 May 2025
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Computer-based high-validity birth simulator

Conditions studied

• Shoulder Dystocia — all drugs for Shoulder Dystocia →
• Simulation Based Medical Education — all drugs for Simulation Based Medical Education →
• Midwifery — all drugs for Midwifery →

Sponsor

Sakarya University

Who can join

18 and older, female only, with Shoulder Dystocia or Simulation Based Medical Education. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.