- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07788495
The Effect of Simulation-Based Oxytocin Induction Training on Midwifery Students' Knowledge and Anxiety Levels
24 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Beykoz
-
Istanbul, Beykoz, Turkiet (Türkiye), 34810
- Istanbul Medipol University, Faculty of Health Sciences
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Aktiv komparator: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Oxytocin Induction Knowledge Score
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in State Anxiety Score
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 november 2024
Primärt slutförande (Faktisk)
26 maj 2025
Avslutad studie (Faktisk)
26 maj 2025
Studieregistreringsdatum
Först inskickad
2 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
24 augusti 2026
Första postat (Faktisk)
26 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- E-10840098-202.3.02-7862
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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