- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05928481
The Effect Of Sımulatıon-Based Postpartum Bleedıng Management On Mıdwıfery Students
The Effect of Simulation-based Postpartum Hemorrhage Management on the Practice Skills, Satisfaction and Self-efficacy Levels of Midwifery Students
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 population consisted of 3rd grade students who took the "Risky Birth and Postpartum Period" course, studying at the Department of Midwifery, Hamidiye Faculty of Health Sciences, in the spring semester of the 2021-2022 academic year (N:82). Students who volunteered to participate in the study were included in the study. In the study, the entire target population was reached, except for the 4 students who were absent from the "Risky Birth and Postpartum Period" course (N:78). Computer-assisted randomization will be used in the study, and random assignment was made to the intervention (n:39) and control (n:39) groups by entering the number of cases through the program whose URL address is https://www.randomizer.org.
An introductory information form was applied to all groups, and informed consent was obtained from the students before the applications. The students were given information about the introduction of the simulator and the model, the flow chart of the training plan, the content of the training plan, the environment, the locations of the materials. Before the application, all groups were given theoretical information about postpartum hemorrhage management for 2 hours with a power point presentation. "Student Satisfaction and Self-Confidence Scale in Learning" and "Self-Efficacy Scale" were applied as a pre-test after the information. Intervention group students were given practical training on postpartum hemorrhage assessment and management in the basic skills laboratory, accompanied by an adult standard patient care model, with a high-reality Gaumard Scientific brand, product code: S550.100 Noella simulator in the simulation laboratory of the Midwifery department. After the application, "Student Satisfaction and Self-Confidence in Learning Scale", "Self-Efficacy Scale" and "Early Postpartum Hemorrhage Management Skill Assessment Form" were applied to all students as a post-test, and "Scale for Evaluation of Simulation-Based Learning" to the intervention group. Four weeks after the training, the "Early Postpartum Hemorrhage Management Skill Assessment Form" and "Self-Efficacy Scale" were applied to the students again as a follow-up test.
After the research was completed, postpartum hemorrhage management was applied to the control group students with a high-reality simulator, accompanied by a scenario, so that all students could benefit from the benefits of simulation-based education. At the end of the simulation applications, an analysis session was held for the students accompanied by the video recordings taken during the applications. During the debriefing session, it was aimed to help students see their mistakes and organize their practices without judging by using a constructive language.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34668
- University of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
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: İntervention group (n:39)
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.
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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.
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No Intervention: Control group (n:39)
Postpartum hemorrhage management practices were applied to the students in the control group on a standard adult patient model in the basic skills laboratory.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Introductory Information Form
Time Frame: 5 minutes
|
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.
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5 minutes
|
|
Student Satisfaction and Self-Confidence Scale in Learning
Time Frame: 10 minutes
|
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
Time Frame: 10 minutes
|
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.
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10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Student Satisfaction and Self-Confidence Scale in Learning
Time Frame: 10 minutes
|
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
Time Frame: 10 minutes
|
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
|
|
Evaluation Scale of Simulation-Based Learning
Time Frame: 10 minutes
|
There are 37 items in the scale, which consists of five sub-dimensions.
The answers are scored in a five-point Likert type, ranging from 1 (strongly disagree) to 5 (strongly agree), and the total score varies between 37-185.
All statements in the scale are positive and there is no reverse coded item.
The content validity index of the scale was 0.89, the total Cronbach's alpha value was 0.95 and the Cronbach's alpha values of the sub-dimensions ranged between 0.77-0.90.
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10 minutes
|
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Early Postpartum Bleeding Skill Assessment Form
Time Frame: 20 minutes
|
The form developed by the researchers based on the literature was given its final shape in line with the opinions of twelve experts.
Form; It consists of two parts, "Part I: Early Postpartum Hemorrhage Evaluation Procedure Steps" and "Part II: Behaviors to Observe in Cases of Postpartum Hemorrhage".
first chapter, 30; The second part contains 25 questions and there are 55 questions in total in the scale.
Scale scoring; It was made in line with the parameters "Needs to be Improved (0 Points)", "Adequate (1 Point)", "Mastered (2 points)".
Bleeding management skill levels of students in the early postpartum period, skill evaluation form; the first part is a minimum of 0 points, a maximum of 60 points; the second part is a minimum of 0 points, a maximum of 50 points; their total scores were evaluated with the sum of the points they received, with a minimum of 0 points and a maximum of 110 points.
|
20 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Efficacy Scale
Time Frame: 10 minutes
|
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
|
|
Early Postpartum Bleeding Skill Assessment Form
Time Frame: 20 minutes
|
The form developed by the researchers based on the literature was given its final shape in line with the opinions of twelve experts.
Form; It consists of two parts, "Part I: Early Postpartum Hemorrhage Evaluation Procedure Steps" and "Part II: Behaviors to Observe in Cases of Postpartum Hemorrhage".
first chapter, 30; The second part contains 25 questions and there are 55 questions in total in the scale.
Scale scoring; It was made in line with the parameters "Needs to be Improved (0 Points)", "Adequate (1 Point)", "Mastered (2 points)".
Bleeding management skill levels of students in the early postpartum period, skill evaluation form; the first part is a minimum of 0 points, a maximum of 60 points; the second part is a minimum of 0 points, a maximum of 50 points; their total scores were evaluated with the sum of the points they received, with a minimum of 0 points and a maximum of 110 points.
|
20 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBÜ-AYDINKARTAL-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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