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CompletedNCT07788495Updated Aug 26, 2026

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

An interventional study of Theoretical Training on Oxytocin Induction and Simulation-Based Oxytocin Induction Training in Simulation-based Midwifery Education and Oxytocin Induction, sponsored by Melisa Gündeş. Completed at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2026-08-26.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Melisa Gündeş · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Nov 2024, registered Aug 2026).

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Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Simulation-based Midwifery Education
  • Oxytocin Induction

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Keywords

  • Simulation-based education
  • Midwifery education
  • Oxytocin induction
  • Anxiety
  • Learning level
03

In context

Anxiety Disorders Unverified

7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's enrollment of 80 is close to the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

This is the only study on the registry with Melisa Gündeş as lead sponsor.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • Not meeting one or more of the inclusion criteria
  • Declining to participate in the study
  • Not providing written or verbal
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • 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.

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

  • Active comparator
    Theoretical Training

    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

  • BehavioralTheoretical Training on Oxytocin Induction

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

  • BehavioralSimulation-Based Oxytocin Induction Training

    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.

06

What researchers measure

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.

    Time frame: At baseline, before theoretical training, and 5 weeks after theoretical training

Secondary outcomes

  1. Change in State Anxiety Score

    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.

    Time frame: At baseline, before theoretical training, and 5 weeks after theoretical training

07

Study locations

1 site
  • Istanbul Medipol University, Faculty of Health Sciences
    Istanbul, Beykoz 34810, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2024 to primary completion in May 2025, 6 months.

Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 6 months is below that.

Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2026
First posted
Aug 26, 2026
StartActual
Nov 11, 2024
Primary completionActual
May 26, 2025
CompletionActual
May 26, 2025
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07788495
Lead sponsor
Melisa Gündeş
Responsible party
Melisa Gündeş (Research Assistant, Medipol University) — Sponsor-investigator
First posted
Aug 26, 2026
Start date
Nov 11, 2024
Primary completion
May 26, 2025
Completion
May 26, 2025
Last update
Aug 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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