- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06241443
Nursing Students & Positive Birth Perception & Simulation
January 27, 2024 updated by: sümeyye bakır, Ege University
The Impact of Simulation-Based Education on Positive Birth Perception and Natural Birth Approach
The study aimed to investigate the impact of simulation-based training on nursing students' perception of positive birth and natural birthing approaches.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study aimed to determine whether simulation-based training could improve the perception of positive birth and natural birthing approaches among fourth-year nursing students.
The study used a randomized controlled quasi-experimental design with pre-test and post-test.
The intervention group received hybrid simulation, while the other received video-modeling training.
The study used several tools to assess the impact of the training, including the Demographic Information Form, Natural Birth Approach Questionnaire, Student Satisfaction and Confidence in Learning Scale, Satisfaction with Education Methods Questionnaire, and Natural Birth Approach Clinical Skills Guide.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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İzmir, Turkey, 3500
- Ege Univesity
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- During the study, participants must complete all forms, attend all theoretical training, and remain in the study until completion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: hybrid simulation
These students participated in a natural birth approach scenario with a hybrid simulation (n=28).
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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.
|
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Active Comparator: video-modeling group
The students in this group participated in a video modeling education (n=28).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
students' self-confidence and satisfaction
Time Frame: through simulation practices completion, an average of 5 weeks
|
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.
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through simulation practices completion, an average of 5 weeks
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Natural Birth Approach Questionnaire
Time Frame: change from before implemention and 4th week of after practice
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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.
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change from before implemention and 4th week of after practice
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education methods satisfaction
Time Frame: through simulation practices completion, an average of 5 weeks
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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.
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through simulation practices completion, an average of 5 weeks
|
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Natural Birth Approach Skills
Time Frame: through simulation practices completion, an average of 5 weeks
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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.
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through simulation practices completion, an average of 5 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: sümeyye bakır, master, Ege University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2022
Primary Completion (Actual)
May 20, 2023
Study Completion (Actual)
June 20, 2023
Study Registration Dates
First Submitted
January 27, 2024
First Submitted That Met QC Criteria
January 27, 2024
First Posted (Actual)
February 5, 2024
Study Record Updates
Last Update Posted (Actual)
February 5, 2024
Last Update Submitted That Met QC Criteria
January 27, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- E.1161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The researchers intend to publish the study as an article
IPD Sharing Time Frame
from January 2025
IPD Sharing Access Criteria
the article is planned to be published as open access
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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