Postpartum HemorrhageNCT05928481
The Effect Of Sımulatıon-Based Postpartum Bleedıng Management On Mıdwıfery Students
A study testing Simulation-based postpartum bleeding management training in people with Postpartum Hemorrhage, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Simulation-based postpartum bleeding management training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Simulation-based Postpartum Hemorrhage Management on the Practice Skills, Satisfaction and Self-efficacy Levels of Midwifery Students
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.
Read the 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.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Simulation-based postpartum bleeding management training
- Keywords
- Simulation, Midwifery, Postpartum hemorrhage, Satisfaction, Self-efficacy
- Medical subject headings
- Postpartum Hemorrhage, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-based postpartum bleeding management trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 10 minutes
Secondary outcomes (4)
Evaluation Scale of Simulation-Based Learning
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.
Measured: 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.
Measured: 10 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.
Measured: 10 minutes
Early Postpartum Bleeding Skill Assessment Form
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Mar 2022
- Primary completion30 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled single-blind experimental study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928481
- Sponsor's protocol ID
- SBÜ-AYDINKARTAL-001
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation-based Postpartum Hemorrhage Management on the Practice Skills, Satisfaction and Self-efficacy Levels of Midwifery Students
- ClinicalTrials.gov ID
- NCT05928481
- Acronym / sponsor ID
- SBÜ-AYDINKARTAL-001
- Conditions
- Postpartum Hemorrhage
- Keywords
- Simulation, Midwifery, Postpartum hemorrhage, Satisfaction, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled single-blind experimental study
| Arm | Type | Receives |
|---|---|---|
| İntervention group (n:39) | Experimental | Other: Simulation-based postpartum bleeding management trainingPostpartum 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation-based postpartum bleeding management trainingPostpartum 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 | İntervention group (n:39) |
Primary outcome
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.
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.
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.
4 secondary outcomes
Evaluation Scale of Simulation-Based Learning
Time frame: 10 minutes
Self-Efficacy Scale
Time frame: 10 minutes
Student Satisfaction and Self-Confidence Scale in Learning
Time frame: 10 minutes
Early Postpartum Bleeding Skill Assessment Form
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-based postpartum bleeding management training in people with Postpartum Hemorrhage, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.