NCT05928481

Brief Summary

This study was planned to determine the effect of simulation-based postpartum hemorrhage management on the application skills, satisfaction, self-confidence and self-efficacy-competences of Health Sciences University Hamidiye Health Sciences Faculty Midwifery Department 3rd year students. The research, which was planned in a randomized controlled experimental design, will be conducted with Istanbul Health Sciences University Hamidiye Health Sciences Faculty 3rd year midwifery (N:82) students. Students participating in the study will be divided into intervention (n:41) and control (n:41) groups according to the computer-assisted simple random sampling technique. Before the application, both groups will be given 2 hours of theoretical information on the evaluation and management of postpartum hemorrhage. 41 students assigned to the intervention group will be given a high-fidelity simulator, and 41 students assigned to the control group will be given practical training accompanied by an adult standard patient care model. "Descriptive Information Form", "Evaluation of Simulation-Based Learning Scale", "Student Satisfaction and Self-Confidence in Learning Scale", "Self-Efficacy Scale" and "Early Postpartum Hemorrhage Management Skill Evaluation Form" will be applied to the students participating in the research.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

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

March 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

June 23, 2023

Last Update Submit

June 23, 2023

Conditions

Keywords

SimulationMidwiferyPostpartum hemorrhageSatisfactionSelf-efficacy

Outcome Measures

Primary Outcomes (3)

  • Introductory Information Form

    In this form, which was created by the researchers based on the literature, the participants' age, the high school they graduated from, the education level of their parents, their willingness to choose the profession, their feeling of belonging to the profession, etc. questions are included.

    5 minutes

  • Student Satisfaction and Self-Confidence Scale in Learning

    According to the Turkish version of the scale, the total number of items is 12. This scale measures student satisfaction and self-confidence towards learning in a simulation environment. The scale consists of two sub-titles: "Satisfaction with Current Learning" and "Self-Confidence in Learning". There is no negative item in the scale. A 5-point likert expressing student feelings was used; 1) Strongly disagree, 2) Disagree, 3) Undecided, 4) Agree, and 5) Strongly Agree. Cronbach's alpha value was 0.85 for "Satisfaction with Current Learning" and 0.77 for "Self-Confidence in Learning". In the scoring of the scale, the formula of dividing the total score obtained by the answers by the number of item 33 is used. In the scoring, 1 point was determined as the lowest and 5 points as the highest. As the total score obtained from the scale increases, student satisfaction and self-confidence in learning increase.

    10 minutes

  • Self-Efficacy Scale

    The scale, which does not belong to any subjective domain, measures the perception of general self-efficacy and efficacy. The Self-Efficacy Scale is structured as a 5-point Likert-type scale consisting of 23 items, and a minimum of 23 and a maximum of 115 points can be obtained from the scale. For each item on the scale, one of the options 1-Does not describe me at all, 2-Describes me a little, 3-I am undecided, 4-Describes me well, 5-Describes me very well, is based on the score given for each item. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 on the scale are scored in the opposite direction. An increase in the total score that can be obtained from the scale indicates that the general self-efficacy-efficacy perception is high.

    10 minutes

Secondary Outcomes (4)

  • Evaluation Scale of Simulation-Based Learning

    10 minutes

  • Self-Efficacy Scale

    10 minutes

  • Student Satisfaction and Self-Confidence Scale in Learning

    10 minutes

  • Early Postpartum Bleeding Skill Assessment Form

    20 minutes

Other Outcomes (2)

  • Early Postpartum Bleeding Skill Assessment Form

    20 minutes

  • Self-Efficacy Scale

    10 minutes

Study Arms (2)

İntervention group (n:39)

EXPERIMENTAL

Postpartum hemorrhage management practices were applied to the students in the intervention group on a high-reality Gaumard Scientific brand, product code: S550.100 Noella simulator in the simulation laboratory of the Midwifery department.

Other: Simulation-based postpartum bleeding management training

Control group (n:39)

NO INTERVENTION

Postpartum hemorrhage management practices were applied to the students in the control group on a standard adult patient model in the basic skills laboratory.

Interventions

Postpartum hemorrhage management practices were applied to the students in the intervention group on a high-reality Gaumard Scientific brand, product code: S550.100 Noella simulator in the simulation laboratory of the Midwifery department.

İntervention group (n:39)

Eligibility Criteria

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

You may qualify if:

  • Volunteering to participate in the research.
  • Being a third year student at SBU, Hamidiye Faculty of Health Sciences, Midwifery Department.
  • To have successfully completed the theory and practice of basic principles and practices in midwifery.
  • To have taken the risky birth and postpartum period lesson.

You may not qualify if:

  • Not volunteering to participate in the research.
  • Not to be a third year student at the Faculty of Health Sciences, Hamidiye, Department of Midwifery.
  • Not having successfully completed the theory and practice of basic principles and practices in midwifery.
  • Not having taken the risky birth and postpartum lesson.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postpartum HemorrhagePersonal Satisfaction

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized controlled single-blind experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 3, 2023

Study Start

March 1, 2022

Primary Completion

April 30, 2022

Study Completion

May 31, 2022

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations