The Effect of Simulation-Based Oxytocin Induction Training on Midwifery Students' Knowledge and Anxiety Levels

NCT07788495 | Completed

• 1 other identifier: E-10840098-202.3.02-7862
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study was conducted to evaluate the effect of simulation-based oxytocin induction training on midwifery students' knowledge and anxiety levels. The study population consisted of third-year midwifery students enrolled in the Faculty of Health Sciences at Istanbul Medipol University during the spring semester of the 2024-2025 academic year. Eligible students who volunteered to participate were randomly assigned to an intervention group or a control group. Both groups received theoretical training on oxytocin induction management. In addition to the theoretical training, the intervention group received simulation-based oxytocin induction training using a high-fidelity simulator and a standardized patient. Data were collected between April and May 2025 using the Introductory Information Form, Oxytocin Induction Knowledge Assessment Form, Objective Structured Clinical Evaluation Form, State-Trait Anxiety Inventory, Simulation Design Scale, Student Satisfaction and Self-Confidence in Learning Scale, and Educational Practices Questionnaire.

Conditions

Simulation-based Midwifery Education; Oxytocin Induction

Keywords

Simulation-based education; Midwifery education; Oxytocin induction; Anxiety; Learning level

Outcome Measures

Primary Outcomes (1)

• Change in Oxytocin Induction Knowledge Score

  Knowledge of oxytocin induction was assessed using the 28-item Oxytocin Induction Knowledge Assessment Form. Each item was answered as "True," "False," or "I do not know." Correct answers were scored as 1, while incorrect answers and "I do not know" responses were scored as 0. The total score ranged from 0 to 28, with higher scores indicating a higher level of knowledge regarding oxytocin induction and its management. Changes in total knowledge scores between baseline and follow-up assessments were evaluated.

  At baseline, before theoretical training, and 5 weeks after theoretical training

Secondary Outcomes (1)

• Change in State Anxiety Score

  At baseline, before theoretical training, and 5 weeks after theoretical training

Study Arms (2)

Theoretical Training + Simulation-Based Training

EXPERIMENTAL

Participants in this arm received theoretical training on oxytocin induction. In addition to the theoretical training, they received simulation-based oxytocin induction training using high-fidelity simulation and a standardized patient.

Behavioral: Theoretical Training on Oxytocin Induction; Behavioral: Simulation-Based Oxytocin Induction Training

Theoretical Training

ACTIVE COMPARATOR

Participants in this arm received theoretical training on oxytocin induction and did not receive the additional simulation-based training.

Behavioral: Theoretical Training on Oxytocin Induction

Interventions

Theoretical Training on Oxytocin Induction BEHAVIORAL

Participants received theoretical training covering the principles and clinical management of oxytocin induction.

Theoretical Training; Theoretical Training + Simulation-Based Training

Simulation-Based Oxytocin Induction Training BEHAVIORAL

Following the theoretical training, participants in the intervention group received simulation-based training on oxytocin induction management using a high-fidelity simulator and a standardized patient.

Theoretical Training + Simulation-Based Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Being enrolled as a third-year undergraduate student in the Department of Midwifery, Faculty of Health Sciences, Istanbul Medipol University, during the spring semester of the 2024-2025 academic year
• Having successfully completed the Childbirth and Postpartum Period course
• Having successfully completed the Childbirth and Postpartum Period Clinical Practice course
• Having a cumulative grade point average of 2.70 or higher
• Volunteering to participate in the study
• Providing written and verbal informed consent

You may not qualify if:

• Declining to participate in the study
• Not providing written or verbal informed consent

Sponsors & Collaborators

• Melisa Gündeş: lead

Study Sites (1)

Istanbul Medipol University, Faculty of Health Sciences

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The randomization sequence and group assignments were generated by an independent individual who was not involved in participant recruitment, training, or outcome assessment. The outcome assessors who evaluated the participants' clinical performance were blinded to group assignments. Due to the nature of the educational intervention, participants and the researchers delivering the training could not be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Model Details: Participants were randomly assigned to two parallel groups. Both groups received theoretical training on oxytocin induction. In addition to the theoretical training, the intervention group received simulation-based oxytocin induction training using high-fidelity simulation and a standardized patient. Participants remained in their assigned groups throughout the study, with no crossover between groups.

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 26, 2026
• Study Start: November 11, 2024
• Primary Completion: May 26, 2025
• Study Completion: May 26, 2025
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

TU (1)