NCT07854106

Brief Summary

Abstract Postpartum hemorrhage (PPH) is a leading cause of maternal mortality and morbidity worldwide, requiring nursing students to acquire both theoretical knowledge and clinical competence for safe and effective management. Hybrid simulation, integrating standardized patients with high-fidelity simulators, is an innovative educational approach that simultaneously enhances communication and psychomotor skills. This prospective randomized controlled study aims to evaluate the effects of a hybrid simulation-based postpartum hemorrhage management training on nursing students' learning satisfaction, self-confidence, and clinical readiness. The study was conducted with third-year nursing students at Eskisehir Osmangazi University Faculty of Health Sciences, Department of Nursing. Participants were randomly assigned to either an intervention group receiving hybrid simulation-based training using standardized patients and a birthing simulator, or a control group receiving routine education. Data were collected before and after the intervention using a Personal Information Form, the Student Satisfaction and Self-Confidence in Learning Scale, and the Nursing Clinical Readiness Scale to evaluate outcomes between the groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2026

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
Last Updated

October 2, 2026

Status Verified

October 1, 2026

Enrollment Period

29 days

First QC Date

September 25, 2026

Last Update Submit

October 1, 2026

Conditions

Keywords

Postpartum HemorrhageClinical ReadinessSimulation TrainingNursing educationlearning satisfaction and self-confidence

Outcome Measures

Primary Outcomes (2)

  • Readiness for Nursing Practice Scale

    Assessed using the Turkish version of the Nursing Clinical Readiness Scale (originally developed by Kim and Shin, 2022; Turkish validation by Kavuran et al., 2023) to evaluate nursing students' clinical readiness in managing postpartum hemorrhage. The scale consists of 35 items rated on a 10-point Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree). Total scores range from 35 to 350 (or mean item scores from 1 to 10), where higher scores indicate a higher level of clinical readiness.

    Baseline and immediately post-intervention

  • Student Satisfaction and Self-Confidence in Learning Scale

    Assessed using the Turkish version of the Student Satisfaction and Self-Confidence in Learning Scale (originally developed by Jeffries and Rizzolo, 2006; Turkish validation by Unver et al., 2017). The scale consists of 12 items across two subscales: Satisfaction with Current Learning (5 items) and Self-Confidence in Learning (7 items), rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Scores are calculated by dividing the sum of scores by the number of items, with mean scores ranging from 1 to 5 (total score range: 12 to 60), where higher scores indicate higher levels of student satisfaction and self-confidence in learning.

    Baseline and immediately post-intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Nursing students receiving hybrid simulation-based postpartum hemorrhage (PPH) management training.

Behavioral: Hybrid Simulation-Based PPH Training

Control Group

ACTIVE COMPARATOR

Nursing students receiving standard postpartum hemorrhage management education.

Behavioral: Standard Education

Interventions

Students receive interactive hybrid simulation-based training combining standardized patients and task trainers focused on postpartum hemorrhage management skills, clinical decision-making, and team communication.

Intervention Group

Students receive traditional curriculum-based theoretical education and standard lecture-based instruction on postpartum hemorrhage management.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being an undergraduate nursing student at Eskisehir Osmangazi University Faculty of Health Sciences
  • Being a third-year student enrolled in the Women's Health and Diseases Nursing course for the first time
  • Volunteering to participate and providing written informed consent
  • Not having previously received structured simulation training on postpartum hemorrhage management
  • Having no physical, cognitive, or psychiatric health conditions that impair communication

You may not qualify if:

  • Incomplete completion of data collection instruments
  • Non-attendance at pre-test or post-test assessments
  • Failure to complete the assigned educational intervention
  • Withdrawal of consent or voluntary withdrawal at any stage of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Osmangazi University Faculty of Health Sciences

Eskişehir, Eyalet/İl Seçin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 2, 2026

Study Start

February 23, 2026

Primary Completion

March 24, 2026

Study Completion

July 29, 2026

Last Updated

October 2, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared publicly to protect participant confidentiality. De-identified data may be made available from the corresponding author upon reasonable request.

Locations