Simulation-based Midwifery EducationNCT07788495
The Effect of Simulation-Based Oxytocin Induction Training on Midwifery Students' Knowledge and Anxiety Levels
A study testing Theoretical Training on Oxytocin Induction and Simulation-Based Oxytocin Induction Training in people with Simulation-based Midwifery Education and Oxytocin Induction, run by Melisa Gündeş at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Simulation-based Midwifery Education, Oxytocin Induction
- What is being tested?
- Theoretical Training on Oxytocin Induction and Simulation-Based Oxytocin Induction Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2024to 26 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not meeting one or more of the inclusion criteria
- Declining to participate in the study
- Not providing written or verbal informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University, Faculty of Health Sciences
Istanbul, Beykoz, 34810
About this study
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.
- Being tested
- Theoretical Training on Oxytocin Induction, Simulation-Based Oxytocin Induction Training
- Keywords
- Simulation-based education, Midwifery education, Oxytocin induction, Anxiety, Learning level
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theoretical Training on Oxytocin InductionBehavioural
Participants received theoretical training covering the principles and clinical management of oxytocin induction.
Simulation-Based Oxytocin Induction TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Theoretical Training on Oxytocin Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline, before theoretical training, and 5 weeks after theoretical training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start11 Nov 2024
- Primary completion26 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation-based Midwifery EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melisa Gündeş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melisa Gündeş, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788495
- Sponsor's protocol ID
- E-10840098-202.3.02-7862
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation-Based Oxytocin Induction Training on Midwifery Students' Knowledge and Anxiety Levels
- ClinicalTrials.gov ID
- NCT07788495
- Acronym / sponsor ID
- E-10840098-202.3.02-7862
- Keywords
- Simulation-based education, Midwifery education, Oxytocin induction, Anxiety, Learning level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Melisa GündeşUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Theoretical Training + Simulation-Based Training | Experimental | Behavioral: Theoretical Training on Oxytocin Induction, Behavioral: Simulation-Based Oxytocin Induction TrainingParticipants 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. |
| Theoretical Training | Active comparator | Behavioral: Theoretical Training on Oxytocin InductionParticipants in this arm received theoretical training on oxytocin induction and did not receive the additional simulation-based training. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Not meeting one or more of the inclusion criteria
- Declining to participate in the study
- Not providing written or verbal informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theoretical Training on Oxytocin InductionParticipants received theoretical training covering the principles and clinical management of oxytocin induction. | Behavioural | Theoretical Training, Theoretical Training + Simulation-Based Training |
| Simulation-Based Oxytocin Induction TrainingFollowing 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. | Behavioural | Theoretical Training + Simulation-Based Training |
Primary outcome
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.
1 secondary outcome
Change in State Anxiety Score
Time frame: At baseline, before theoretical training, and 5 weeks after theoretical training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theoretical Training on Oxytocin Induction and Simulation-Based Oxytocin Induction Training in people with Simulation-based Midwifery Education and Oxytocin Induction, run by Melisa Gündeş at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxytocin Induction Knowledge Score (time frame: At baseline, before theoretical training, and 5 weeks after theoretical training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.