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Effect of Simulation-Based Education on Knowledge, Skills, and Self-Efficacy in Postpartum Hemorrhage Management

29 maggio 2026 aggiornato da: Ömercan Aksoy

Effect of Simulation-Based Education on Knowledge, Skills, and Self-Efficacy in Postpartum Hemorrhage Management: A Randomized Controlled Trial

Postpartum hemorrhage is an important obstetric emergency that requires early recognition and timely management. Midwifery students may have limited opportunities to practise postpartum hemorrhage management repeatedly in real clinical settings. Simulation-based education may help students practise assessment, decision-making, emergency interventions, communication, and documentation in a safe learning environment.

This study evaluated the effect of simulation-based education on third-year midwifery students' knowledge, postpartum hemorrhage management skill performance, and self-efficacy. Participants were randomly assigned to either an intervention group or a control group. Both groups received traditional theoretical education on postpartum hemorrhage management. The intervention group additionally received simulation-based postpartum hemorrhage management education using a high-fidelity birthing simulator.

Knowledge and self-efficacy were assessed before the intervention, immediately after the intervention, and four weeks later. Skill performance was assessed immediately after the intervention and again four weeks later using a structured skills checklist. The study aimed to determine whether simulation-based education improved students' learning outcomes compared with traditional theoretical education alone.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This randomized controlled study was designed to evaluate the effect of simulation-based education on midwifery students' learning outcomes in postpartum hemorrhage management. The study was conducted with third-year undergraduate midwifery students at a university in Istanbul, Türkiye.

Eligible participants were third-year midwifery students who had completed the Normal Birth and Midwifery Care course and were enrolled in the High-Risk Birth and Midwifery Care course during the 2022-2023 academic year. Students who agreed to participate were randomly assigned to an intervention group or a control group.

All participants first received traditional theoretical education on postpartum hemorrhage management. The theoretical education included the definition, importance, etiology, risk factors, prevention, treatment, and management of postpartum hemorrhage. The intervention group then received additional simulation-based postpartum hemorrhage management education. The simulation session was conducted in a simulation laboratory arranged as a postpartum patient room and used a high-fidelity birthing simulator. The simulation included prebriefing, a postpartum hemorrhage scenario, and debriefing. Moulage and clinical equipment were used to support scenario realism.

The control group received traditional theoretical education only and did not participate in the simulation-based education session. Participants in both groups completed the same outcome assessments.

The primary learning outcomes were postpartum hemorrhage management knowledge, skill performance, and self-efficacy. Knowledge was measured using the Postpartum Hemorrhage Management Knowledge Test. Self-efficacy was measured using the Postpartum Hemorrhage Management Self-Efficacy Form. Skill performance was assessed using the Postpartum Hemorrhage Management Skills Checklist by external observers.

Knowledge and self-efficacy were measured at three time points: baseline, immediately after the intervention, and four weeks after the intervention. Skill performance was assessed immediately after the intervention and at the four-week follow-up. The study compared changes in these outcomes between the intervention and control groups to determine whether simulation-based education provided additional benefit beyond traditional theoretical education.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

45

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • Third-year undergraduate midwifery students enrolled in the Department of Midwifery during the 2022-2023 academic year
  • Completion of the Normal Birth and Midwifery Care course
  • Enrollment in the High-Risk Birth and Midwifery Care course during the study period
  • Voluntary agreement to participate in the study
  • Ability to attend all study sessions and follow-up assessments

Exclusion Criteria:

  • Previous participation in structured postpartum hemorrhage simulation-based training
  • Absence from any part of the educational intervention or outcome assessments
  • Withdrawal of consent during the study period

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Simulation-Based PPH Management Education Group
Participants in this arm received traditional theoretical education on postpartum hemorrhage management followed by simulation-based postpartum hemorrhage management education using a high-fidelity birthing simulator. The simulation session included prebriefing, a postpartum hemorrhage scenario, and debriefing.
Comportamentale: Simulation-Based Postpartum Hemorrhage Management Education
Simulation-based education was delivered using a high-fidelity birthing simulator in a simulation laboratory arranged as a postpartum patient room. The session included a 5-minute prebriefing, a 15-minute postpartum hemorrhage management scenario, and a 30-minute debriefing. The scenario required learners to assess vital signs, lochia, fundus, pain, and IV catheter status; recognize postpartum hemorrhage; communicate using SBAR; initiate emergency interventions; and document care.Simulation-based education was delivered using a high-fidelity birthing simulator in a simulation laboratory arranged as a postpartum patient room. The session included a 5-minute prebriefing, a 15-minute postpartum hemorrhage management scenario, and a 30-minute debriefing. The scenario required learners to assess vital signs, lochia, fundus, pain, and IV catheter status; recognize postpartum hemorrhage; communicate using SBAR; initiate emergency interventions; and document care.
Altri nomi:
  • Simulation-based PPH management education
Comportamentale: Traditional Theoretical Postpartum Hemorrhage Education
Traditional theoretical education was delivered face-to-face in a classroom setting and lasted approximately one hour. The session covered the definition, importance, etiology, risk factors, prevention, treatment, and management of postpartum hemorrhage. The education was supported by a PowerPoint presentation and included lecture, question-answer, discussion, and brainstorming methods.
Altri nomi:
  • Traditional theoretical PPH education
Comparatore attivo: Traditional Theoretical PPH Education Group
Participants in this arm received traditional theoretical education on postpartum hemorrhage management only. They did not receive simulation-based education during the study period.
Comportamentale: Traditional Theoretical Postpartum Hemorrhage Education
Traditional theoretical education was delivered face-to-face in a classroom setting and lasted approximately one hour. The session covered the definition, importance, etiology, risk factors, prevention, treatment, and management of postpartum hemorrhage. The education was supported by a PowerPoint presentation and included lecture, question-answer, discussion, and brainstorming methods.
Altri nomi:
  • Traditional theoretical PPH education

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PPH Management Skill Performance Score
Lasso di tempo: Post-intervention and four-week follow-up
PPH management skill performance was assessed using the Postpartum Hemorrhage Management Skills Checklist. The checklist includes 23 items scored as 0 = needs improvement, 1 = partially adequate, and 2 = adequate. Total scores range from 0 to 46, with higher scores indicating better PPH management skill performance.PPH management skill performance was assessed using the Postpartum Hemorrhage Management Skills Checklist. The checklist includes 23 items scored as 0 = needs improvement, 1 = partially adequate, and 2 = adequate. Total scores range from 0 to 46, with higher scores indicating better PPH management skill performance.
Post-intervention and four-week follow-up

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PPH Management Knowledge Score
Lasso di tempo: Baseline, post-intervention, and four-week follow-up
PPH management knowledge was assessed using the Postpartum Hemorrhage Management Knowledge Test. The test includes 23 items scored as 0 = incorrect and 1 = correct. Total scores range from 0 to 23, with higher scores indicating higher knowledge of PPH management.
Baseline, post-intervention, and four-week follow-up
PPH Management Self-Efficacy Score
Lasso di tempo: Baseline, post-intervention, and four-week follow-up
PPH management self-efficacy was assessed using the Postpartum Hemorrhage Management Self-Efficacy Form. The form includes 13 items rated on a five-point Likert scale. Total scores range from 13 to 65, with higher scores indicating higher perceived self-efficacy in PPH management.
Baseline, post-intervention, and four-week follow-up

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ömercan Aksoy

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2023

Completamento primario (Effettivo)

15 giugno 2023

Completamento dello studio (Effettivo)

15 giugno 2023

Date di iscrizione allo studio

Primo inviato

24 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 maggio 2026

Primo Inserito (Effettivo)

1 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • E-22686390-050.99-24891

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared because participant consent did not include permission for sharing de-identified individual-level data outside the primary research group.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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