Postpartum CareNCT05928494
The Effect of High Reality Simulation Method on Problem Solving Skills and Anxiety Levels of Midwifery Students
A study testing Scenario-based high-fidelity simulation method in people with Postpartum Care, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effect of scenario-based high-fidelity simulation method on the application problem solving skills and anxiety levels of the 3rd year students of Health Sciences University Hamidiye Health Sciences Faculty Midwifery Department. 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 Care
- What is being tested?
- Scenario-based high-fidelity simulation method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 31 Oct 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 Scenario Based High Reality Simulation Method on Problem Solving Skills and Anxiety Levels of Midwifery Students
This study was planned to determine the effect of scenario-based high-fidelity simulation method on the application problem solving skills and anxiety levels of the 3rd year students of Health Sciences University Hamidiye Health Sciences Faculty Midwifery Department. The research, which is planned in a experimental design, will be carried out with Istanbul Health Sciences University Hamidiye Health Sciences Faculty 3rd year midwifery (N:80) students. Students participating in the study will be divided into intervention (n:40) and control (n:40) groups according to the computer-assisted simple random sampling technique. Intervention group students will be given an application about postpartum care on a standard adult patient model in the high-validity simulation laboratory accompanied by a scenario, and control group students will be made in the vocational skills laboratory. "Descriptive Information Form", "State Anxiety Inventory", "Problem Solving Inventory" and "Satisfaction Questionnaire with Educational Methods" will be applied to the students participating in the research.
Read the detailed description
This study was planned to determine the effect of scenario-based high-fidelity simulation method on the application problem solving skills and anxiety levels of the 3rd year students of Health Sciences University Hamidiye Health Sciences Faculty Midwifery Department.
The universe of the research consisted of 3rd grade students who took the "Risky Birth and Postpartum Period" course in the Midwifery Department of the Faculty of Health Sciences of Hamidiye in the spring semester of the 2021-2022 academic year (N:80). Students who volunteered to participate in the study were included in the study. Computer-assisted randomization will be used in the study, and random assignment was made to the intervention (n:40) and control (n:40) groups by entering the number of cases through the program with the URL address https://www.randomizer.org. Before the application, the "Informed Voluntary Consent Form" was shared with the students and their consent was obtained.
All groups were informed before the applications. In this context, a question-and-answer session was held by giving information about the applications to be made regarding the research. 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 care for 2 hours with a power point presentation. After the information, the "Descriptive Information Form" was applied to the students, and the "State Anxiety Inventory" and "Problem Solving Inventory" were applied as a pre-test. Postpartum care applications were carried out for 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, and on the standard adult patient model in the basic skills laboratory for the control group students. After the training, "State Anxiety Inventory", "Problem Solving Inventory" and "Satisfaction Questionnaire with Educational Methods" were applied to all students as a post-test.
- Conditions
- Postpartum Care
- Being tested
- Scenario-based high-fidelity simulation method
- Keywords
- Problem Solving Skill, Simulation, Midwifery, State Anxiety, Student
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scenario-based high-fidelity simulation methodOther
Postpartum care applications were carried out with the high-reality Gaumard Scientific brand, product code: S550.100 Noella simulator in the simulation laboratory of the midwifery department to the students in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| İntervention group (n:39) | Experimental | Postpartum care applications were carried out with the high-reality Gaumard Scientific brand, product code: S550.100 Noella simulator in the simulation laboratory of the midwifery department to the students in the intervention group. Receives: Other: Scenario-based high-fidelity simulation method |
| Control group (n:39) | No intervention | Postpartum care practices were performed on the standard adult patient model in the basic skills laboratory of the midwifery department for the students in the control group. |
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: 10 minutes
State Anxiety Inventory
The scale consists of two subscales, continuous and state, each consisting of 20 questions. It can be applied to individuals over the age of 14. The state anxiety scale determines how the individual feels at a certain moment and under certain conditions, while the trait anxiety scale determines how the individual feels independently of the situation and conditions. The scores obtained from the scale theoretically vary between 20 and 80. A high score indicates a high level of anxiety and a low score indicates a low level of anxiety.
Measured: 10 minutes
Problem Solving Inventory
Originally, the problem solving inventory was applied to prospective teachers by Heppner and Petersen, and the Cronbach Alpha internal consistency coefficient obtained for all of them was found to be 0.90. Erenler applied the inventory to nurses and found the Cronbach Alpha coefficient to be 0.77. These results show that the inventory is valid and reliable. However, in the literature, it is seen that the problem solving inventory is also used in studies in the field of nursing. In the problem solving inventory, each question is given a score between 1 and 6. In the scoring of the inventory, the lowest score is 32 and the highest score is 192. The high total scores obtained from the scale are interpreted that the individual perceives himself/herself as inadequate in problem solving skills.
Measured: 10 minutes
Secondary outcomes (3)
State Anxiety Inventory
The scale consists of two subscales, continuous and state, each consisting of 20 questions. It can be applied to individuals over the age of 14. The state anxiety scale determines how the individual feels at a certain moment and under certain conditions, while the trait anxiety scale determines how the individual feels independently of the situation and conditions. The scores obtained from the scale theoretically vary between 20 and 80. A high score indicates a high level of anxiety and a low score indicates a low level of anxiety.
Measured: 10 minutes
Problem Solving Inventory
Originally, the problem solving inventory was applied to prospective teachers by Heppner and Petersen, and the Cronbach Alpha internal consistency coefficient obtained for all of them was found to be 0.90. Erenler applied the inventory to nurses and found the Cronbach Alpha coefficient to be 0.77. These results show that the inventory is valid and reliable. However, in the literature, it is seen that the problem solving inventory is also used in studies in the field of nursing. In the problem solving inventory, each question is given a score between 1 and 6. In the scoring of the inventory, the lowest score is 32 and the highest score is 192. The high total scores obtained from the scale are interpreted that the individual perceives himself/herself as inadequate in problem solving skills.
Measured: 10 minutes
Satisfaction Survey with Training Methods
The questionnaire consists of 16 propositions. One of these propositions is the proposition "I am satisfied with this education method in general", which questions the state of being satisfied with the education. Other propositions were formed from propositions aiming to determine the views of the education method in general about the contribution of the education method to the learning and professional life of the student. Each proposition is scored on a 5-point Likert scale (1-strongly disagree, 5-strongly agree). It is determined that as the scale score average increases, students' satisfaction with the education method increases, and as the scale score average decreases, their satisfaction with the education method decreases.
Measured: 10 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 Aug 2022
- Primary completion30 Sep 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum CareStudies of the same condition, open and under way.
- 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
- Other
- 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
- Investigators
- Yasemin AYDIN KARTAL Assoc. Prof. Dr., Principal investigator, Saglik Bilimleri UniversitesiSema AKER Research Assıstant, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928494
- Sponsor's protocol ID
- SBÜ-AYDINKARTAL-003
- Status last verified
- May 2024
- First submitted
- 23 Jun 2023
- Last updated
- 24 May 2024
- 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 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Scenario Based High Reality Simulation Method on Problem Solving Skills and Anxiety Levels of Midwifery Students
- ClinicalTrials.gov ID
- NCT05928494
- Acronym / sponsor ID
- SBÜ-AYDINKARTAL-003
- Conditions
- Postpartum Care
- Keywords
- Problem Solving Skill, Simulation, Midwifery, State Anxiety, Student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Oct 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 scenario-based high-fidelity simulation method on the application problem solving skills and anxiety levels of the 3rd year students of Health Sciences University Hamidiye Health Sciences Faculty Midwifery Department. The research, which is planned in a experimental design, will be carried out with Istanbul Health Sciences University Hamidiye Health Sciences Faculty 3rd year midwifery (N:80) students. Students participating in the study will be divided into intervention (n:40) and control (n:40) groups according to the computer-assisted simple random sampling technique. Intervention group students will be given an application about postpartum care on a standard adult patient model in the high-validity simulation laboratory accompanied by a scenario, and control group students will be made in the vocational skills laboratory. "Descriptive Information Form", "State Anxiety Inventory", "Problem Solving Inventory" and "Satisfaction Questionnaire with Educational Methods" will be applied to the students participating in the research.
Detailed description
This study was planned to determine the effect of scenario-based high-fidelity simulation method on the application problem solving skills and anxiety levels of the 3rd year students of Health Sciences University Hamidiye Health Sciences Faculty Midwifery Department.
The universe of the research consisted of 3rd grade students who took the "Risky Birth and Postpartum Period" course in the Midwifery Department of the Faculty of Health Sciences of Hamidiye in the spring semester of the 2021-2022 academic year (N:80). Students who volunteered to participate in the study were included in the study. Computer-assisted randomization will be used in the study, and random assignment was made to the intervention (n:40) and control (n:40) groups by entering the number of cases through the program with the URL address https://www.randomizer.org. Before the application, the "Informed Voluntary Consent Form" was shared with the students and their consent was obtained.
All groups were informed before the applications. In this context, a question-and-answer session was held by giving information about the applications to be made regarding the research. 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 care for 2 hours with a power point presentation. After the information, the "Descriptive Information Form" was applied to the students, and the "State Anxiety Inventory" and "Problem Solving Inventory" were applied as a pre-test. Postpartum care applications were carried out for 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, and on the standard adult patient model in the basic skills laboratory for the control group students. After the training, "State Anxiety Inventory", "Problem Solving Inventory" and "Satisfaction Questionnaire with Educational Methods" were applied to all students as a post-test.
Study design
- Primary purpose
- Other
- 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: Scenario-based high-fidelity simulation methodPostpartum care applications were carried out with the high-reality Gaumard Scientific brand, product code: S550.100 Noella simulator in the simulation laboratory of the midwifery department to the students in the intervention group. |
| Control group (n:39) | No intervention | –Postpartum care practices were performed on the standard adult patient model in the basic skills laboratory of the midwifery department for the students in the control group. |
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 |
|---|---|---|
| Scenario-based high-fidelity simulation methodPostpartum care applications were carried out with the high-reality Gaumard Scientific brand, product code: S550.100 Noella simulator in the simulation laboratory of the midwifery department to the students in the intervention group. | Other | İntervention group (n:39) |
Primary outcome
Introductory Information Form
Time frame: 10 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.
State Anxiety Inventory
Time frame: 10 minutes
The scale consists of two subscales, continuous and state, each consisting of 20 questions. It can be applied to individuals over the age of 14. The state anxiety scale determines how the individual feels at a certain moment and under certain conditions, while the trait anxiety scale determines how the individual feels independently of the situation and conditions. The scores obtained from the scale theoretically vary between 20 and 80. A high score indicates a high level of anxiety and a low score indicates a low level of anxiety.
Problem Solving Inventory
Time frame: 10 minutes
Originally, the problem solving inventory was applied to prospective teachers by Heppner and Petersen, and the Cronbach Alpha internal consistency coefficient obtained for all of them was found to be 0.90. Erenler applied the inventory to nurses and found the Cronbach Alpha coefficient to be 0.77. These results show that the inventory is valid and reliable. However, in the literature, it is seen that the problem solving inventory is also used in studies in the field of nursing. In the problem solving inventory, each question is given a score between 1 and 6. In the scoring of the inventory, the lowest score is 32 and the highest score is 192. The high total scores obtained from the scale are interpreted that the individual perceives himself/herself as inadequate in problem solving skills.
3 secondary outcomes
State Anxiety Inventory
Time frame: 10 minutes
Problem Solving Inventory
Time frame: 10 minutes
Satisfaction Survey with Training Methods
Time frame: 10 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 24 May 2024.
- 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.
Yasemin AYDIN KARTAL Assoc. Prof. Dr. principal investigator
Saglik Bilimleri Universitesi
Sema AKER Research Assıstant study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scenario-based high-fidelity simulation method in people with Postpartum Care, 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 24 May 2024. 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: 10 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 24 May 2024.