- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07788495
The Effect of Simulation-Based Oxytocin Induction Training on Midwifery Students' Knowledge and Anxiety Levels
24. august 2026 oppdatert 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.
Studieoversikt
Status
Fullført
Studietype
Intervensjonell
Registrering (Faktiske)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Beykoz
-
Istanbul, Beykoz, Tyrkia (Türkiye), 34810
- Istanbul Medipol University, Faculty of Health Sciences
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Oxytocin Induction Knowledge Score
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in State Anxiety Score
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
11. november 2024
Primær fullføring (Faktiske)
26. mai 2025
Studiet fullført (Faktiske)
26. mai 2025
Datoer for studieregistrering
Først innsendt
2. august 2026
Først innsendt som oppfylte QC-kriteriene
24. august 2026
Først lagt ut (Faktiske)
26. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- E-10840098-202.3.02-7862
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .