NCT06872879

Brief Summary

This study was planned to determine the effect of simulation-based training using two different reality levels-visually enhanced mental simulation (VEMS) and hybrid simulation-on postpartum haemorrhage (PPH) management skills in nursing students.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

March 7, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

March 17, 2025

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

24 days

First QC Date

March 7, 2025

Last Update Submit

March 7, 2025

Conditions

Keywords

Simulation TrainingNursingPostpartum Hemorrhage

Outcome Measures

Primary Outcomes (2)

  • PPH management skill levels

    The form, which enables the assessment of students' skills in the PPH management process, consists of 25 steps.

    2 weeks after the completion of the simulation training

  • Satisfaction and self-confidence levels in learning

    Student Satisfaction and Confidence in Learning Scale will be used.

    2 weeks after the completion of the simulation training

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Students in the VEMS (Visually Enhanced Mental Simulation) group will receive a structured training programme to improve their PPH management skills.

Other: VEMS Simulation

Group 2

ACTIVE COMPARATOR

Students in the hybrid simulation group will receive a simulation-based training in which the standard patient and part task trainer are used together.

Other: Hybrit Simulation

Interventions

Students in the VEMS (Visually Enhanced Mental Simulation) group will receive a structured training programme to improve their PPH management skills. This process consists of three main stages: Theoretical training, skills training and simulation practice. 1.1 hour theoretical training will be given to the students to remind them the basic information about PPH management. 2\. PPH management will be mentally visualised step by step using VEMS materials. Students will be individually involved in the scenario and will apply the steps of PPH management in a mental simulation environment. After the scenario is completed, a 30-minute debriefing session will be organised. 3\. Manikin simulation will be used to evaluate students' PPH management skills. Students' PPH management skills will be evaluated using the "Postpartum Haemorrhage Management Observation Form". Attitudes towards the learning process will be measured by applying the Student Satisfaction and Confidence in Learning Scale.

Group 1

Students in the hybrid simulation group will receive a simulation-based training in which the standard patient and part task trainer are used together. This process consists of three main stages: theoretical training, skills training and simulation practice. 1.1 hour theoretical training to remind basic information about PPH management. 2. Standard patient and part task trainers will be used in the skills training of the students. Students will make patient assessment, check vital signs and plan necessary interventions by contacting the standard patient.After the scenario is completed, a 30-minute debriefing session will be organised. 3\. Manikin simulation will be used to evaluate students' PPH management skills. Students' PPH management skills will be evaluated using the "Postpartum Haemorrhage Management Observation Form". Attitudes towards the learning process will be measured by applying the Student Satisfaction and Confidence in Learning Scale.

Group 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to participate in the research
  • To have a grade point average of 2.00 and above

You may not qualify if:

  • Not participating in all stages of the training programme
  • Incomplete completion of data collection tools
  • Wanting to leave the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Central Study Contacts

Yılda Arzu ABA, RN, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Since the researcher is implementing the educational interventions and the students are aware of the interventions in the study, blinding will not be performed in this study. However, during the data analysis phase, the groups will be named as 1 and 2. Thus, the researcher performing the data analysis will be blinded to the type of intervention applied to the participants.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study was a parallel design randomised comparative study designed with equality experiment to determine the effect of simulation-based training using two different reality levels (visually enhanced mental simulation (VEMS) and hybrid simulation) on PPH management skills in nursing students.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 12, 2025

Study Start

March 17, 2025

Primary Completion

April 10, 2025

Study Completion

April 24, 2025

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share