NCT06241443

Brief Summary

The study aimed to investigate the impact of simulation-based training on nursing students' perception of positive birth and natural birthing approaches.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Last Updated

February 5, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

January 27, 2024

Last Update Submit

January 27, 2024

Conditions

Keywords

childbirth experiencenursing studentssimulation-based educationpositive birth

Outcome Measures

Primary Outcomes (4)

  • Natural Birth Approach Questionnaire

    The researchers developed a measurement tool to assess students' knowledge, opinions, and approaches to natural birth. The tool uses a scoring system where correct statements receive one point and incorrect statements receive zero points. The total score ranges from 0 to 100 points.

    change from before implemention and 4th week of after practice

  • students' self-confidence and satisfaction

    It is a scale published by the National League for Nurses (NLN) to measure students' attitudes and beliefs about simulation.The highest score that can be obtained from the scale is 65 and the lowest score is 13.

    through simulation practices completion, an average of 5 weeks

  • education methods satisfaction

    It evaluates the degree of contentment of the student with the teaching methodology implemented.In evaluating the satisfaction with training methods, students are scored from 20 to 80.

    through simulation practices completion, an average of 5 weeks

  • Natural Birth Approach Skills

    The researchers developed a checklist to assess skills. Each item was evaluated on a 3-point scale indicating inadequacy, partial sufficiency, or sufficiency. The checklist consists of 21 items. The total score ranges from 21 to 63 points.

    through simulation practices completion, an average of 5 weeks

Study Arms (2)

hybrid simulation

EXPERIMENTAL

These students participated in a natural birth approach scenario with a hybrid simulation (n=28).

Other: hybrid simulation

video-modeling group

ACTIVE COMPARATOR

The students in this group participated in a video modeling education (n=28).

Other: video-modeling

Interventions

During the hybrid simulation, a student and a standardized patient participated. The patient wore a wearable pregnancy model. Before the start of the "Natural Birth Approach Scenario, a pre-briefing session was conducted. The student's performance during the simulation was recorded on video, and each simulation lasted approximately 30 minutes. After the simulation, a debriefing session was held with the student, and feedback was given. Scales were used to evaluate the implementation of the practices.

hybrid simulation

The students in the group had the opportunity to learn through an educational video that followed the "Natural Birth Approach Scenario." Afterward, they put their knowledge into practice and were evaluated using the Birth Approach Clinical Skills Guide. A feedback session followed the practice session. Finally, they were assessed using scales to measure their performance.

video-modeling group

Eligibility Criteria

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

You may qualify if:

  • The voluntarily agree to participate in the study Not having experience with simulation Being a 4th year nursing undergraduate student not working as a nurse

You may not qualify if:

  • During the study, participants must complete all forms, attend all theoretical training, and remain in the study until completion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege Univesity

Izmir, 3500, Turkey (Türkiye)

Location

Related Publications (3)

  • Dunbar-Reid K, Sinclair PM, Hudson D. Advancing renal education: hybrid simulation, using simulated patients to enhance realism in haemodialysis education. J Ren Care. 2015 Jun;41(2):134-9. doi: 10.1111/jorc.12112. Epub 2015 Jan 29.

    PMID: 25631292BACKGROUND
  • Bakke E, Oseth EH, Fofanah T, Sesay I, van Duinen A, Bolkan HA, Westendorp J, Lonnee-Hoffmann R. Vacuum births and barriers to its use: An observational study in governmental hospitals in Sierra Leone. BMJ Open. 2022 Nov 22;12(11):e060773. doi: 10.1136/bmjopen-2022-060773.

  • Duff J, Kardong-Edgren S, Chang TP, Elkin RL, Ramachandra G, Stapleton S, Palaganas JC, Kou M, Gross IT. Closing the gap: a call for a common blueprint for remote distance telesimulation. BMJ Simul Technol Enhanc Learn. 2021 Apr 12;7(4):185-187. doi: 10.1136/bmjstel-2021-000875. eCollection 2021.

Study Officials

  • sümeyye bakır, master

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The students who participated in the research were unaware of their assigned group.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: prospective, parallel, randomized, controlled quasi-experiment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctoral student/research assistant

Study Record Dates

First Submitted

January 27, 2024

First Posted

February 5, 2024

Study Start

September 20, 2022

Primary Completion

May 20, 2023

Study Completion

June 20, 2023

Last Updated

February 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

The researchers intend to publish the study as an article

Shared Documents
STUDY PROTOCOL
Time Frame
from January 2025
Access Criteria
the article is planned to be published as open access

Locations