- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07788495
The Effect of Simulation-Based Oxytocin Induction Training on Midwifery Students' Knowledge and Anxiety Levels
August 24, 2026 updated by: Melisa Gündeş
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beykoz
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Istanbul, Beykoz, Turkey (Türkiye), 34810
- Istanbul Medipol University, Faculty of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Not meeting one or more of the inclusion criteria
- Declining to participate in the study
- Not providing written or verbal informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Theoretical Training + Simulation-Based Training
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.
|
Participants received theoretical training covering the principles and clinical management of oxytocin induction.
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.
|
|
Active Comparator: Theoretical Training
Participants in this arm received theoretical training on oxytocin induction and did not receive the additional simulation-based training.
|
Participants received theoretical training covering the principles and clinical management of oxytocin induction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Oxytocin Induction Knowledge Score
Time Frame: At baseline, before theoretical training, and 5 weeks after theoretical training
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in State Anxiety Score
Time Frame: At baseline, before theoretical training, and 5 weeks after theoretical training
|
State anxiety was assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory.
The subscale consists of 20 items and produces a total score ranging from 20 to 80, with higher scores indicating higher levels of state anxiety.
The change in total state anxiety score between the assessment time points was evaluated.
|
At baseline, before theoretical training, and 5 weeks after theoretical training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 11, 2024
Primary Completion (Actual)
May 26, 2025
Study Completion (Actual)
May 26, 2025
Study Registration Dates
First Submitted
August 2, 2026
First Submitted That Met QC Criteria
August 24, 2026
First Posted (Actual)
August 26, 2026
Study Record Updates
Last Update Posted (Actual)
August 26, 2026
Last Update Submitted That Met QC Criteria
August 24, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-202.3.02-7862
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.