BreastfeedingNCT06458283
Effıcıency Of Hybrıd Based Sımulatıon Method In Breastfeedıng Educatıon
A study testing hiybrid simulation in people with Breastfeeding and Training Group, Sensitivity, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
It was planned to determine the effect of hybrid simulation-based breastfeeding training on the practical skills, satisfaction, self-confidence and self-efficacy of the students of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Training Group, Sensitivity, High Fidelity Simulation Training
- What is being tested?
- hiybrid simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2023to 10 Nov 2024
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a statement of consent Being a second year midwifery student
Who cannot join
- Wishing to withdraw from the research at any time. Not participating in all simulation applications Incompletely filling out data collection forms
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Hamidiye
Istanbul, Üsküdar, 34668
About this study
Official title: Effıcıency Of Hybrıd Based Sımulatıon Method In Breastfeedıng Educatıon Of Mıdwıfery Students
It was planned to determine the effect of hybrid simulation-based breastfeeding training on the practical skills, satisfaction, self-confidence and self-efficacy of the students of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences
Read the detailed description
This study was planned to determine the effect of hybrid simulation-based breastfeeding education on the practical skills, satisfaction, self-confidence and self-efficacy of the students of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences. The research, planned in a randomized controlled experimental design, will be conducted with Istanbul Health Sciences University Hamidiye Health Sciences Faculty midwifery 2nd year students (N: 84). Students participating in the study will be divided into intervention (n: 42) and control (n: 42) groups according to the computer-assisted simple random sampling technique. Both groups will be given 4 hours of theoretical information about breast milk and breastfeeding education before the application. 42 students assigned to the intervention group will receive training with a high-reality simulator fitted to a standard patient, accompanied by a scenario, and 42 students assigned to the control group will receive practice training with an adult standard patient care model. Introductory Information Form, Simulation-Based Learning Evaluation Scale, Student Satisfaction and Self-Confidence in Learning Scale, Self-Efficacy-Sufficiency Scale, Breastfeeding Management Skill Evaluation Form will be applied to the students participating in the research.
As a result of the findings, discussion and conclusions of the study will be written.
It is important to increase the competency level of midwifery students in breastfeeding management in a simulation environment that creates virtual reality, before the care applied on real patients in a clinical environment. It is recommended to integrate high-reality simulators and standard patient methods into the curriculum in the education of midwifery students . This study aims to increase the application skills, satisfaction, self-confidence and self-efficacy levels of midwifery department students with hybrid simulation-based Breastfeeding education, in which two or more simulation types (standard patient and Lactation Simulator) are combined to produce a more realistic simulation experience.
- Conditions
- Breastfeeding, Training Group, Sensitivity, High Fidelity Simulation Training, Medical Simulation, Standardized Patient
- Being tested
- hiybrid simulation, control grup
- Keywords
- simulation based breastfeeding training, breast feeding, midwifery, education, Simulation, Standardized Patient, High Fidelity Simulation Training
- Medical subject headings
- Breast Feeding, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hiybrid simulationOther
The intervention group students were given practical training on breast milk and breastfeeding management in the professional skills laboratory, accompanied by a high-reality simulator accompanied by a scenario, and the control group students were given practical training on breast milk and breastfeeding management in the professional skills laboratory, accompanied by an adult standard patient care model.
control grupOther
low fidelity simulator
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Investigation of the effectiveness of scenario-based standardized patient simulation training and breastfeeding management of midwifery students Receives: Other: hiybrid simulation |
| Control Group | Experimental | Standard training of midwifery students with low fidelty breast model Receives: Other: control grup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-EffectivenessEfficacy Scale
TThe Self-Efficacy Scale is structured as a 5-point Likert scale consisting of 23 items, with a possible score range of 23 to 115. For each item in the scale, respondents are asked to mark one of the following options: 1) Does not describe me at all, 2) Describes me a little, 3) Neutral, 4) Describes me well, and 5) Describes me very well. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 are scored in reverse. A higher score indicates a higher perception of overall self-efficacy.
Measured: immediately before simulation
Self-EffectivenessEfficacy Scale
The Self-Efficacy Scale is structured as a 5-point Likert scale consisting of 23 items, with a possible score range of 23 to 115. For each item in the scale, respondents are asked to mark one of the following options: 1) Does not describe me at all, 2) Describes me a little, 3) Neutral, 4) Describes me well, and 5) Describes me very well. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 are scored in reverse. A higher score indicates a higher perception of overall self-efficacy.
Measured: immediately after the simulation application
Self-EffectivenessEfficacy Scale
The Self-Efficacy Scale is structured as a 5-point Likert scale consisting of 23 items, with a possible score range of 23 to 115. For each item in the scale, respondents are asked to mark one of the following options: 1) Does not describe me at all, 2) Describes me a little, 3) Neutral, 4) Describes me well, and 5) Describes me very well. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 are scored in reverse. A higher score indicates a higher perception of overall self-efficacy.
Measured: 4 weeks after the first simulation application
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. The Introductory Information Form is in a multiple-choice format consisting of 25 questions by scanning the literature by the researchers.
Measured: immediately before simulation
Student Satisfaction and Self-Confidence Scale in Learning
The scale is a 13-item measurement tool designed to measure student satisfaction with simulation and self-confidence during practices. It is a 5-point Likert type and is scored as strongly disagree 1, disagree 2, undecided 3, agree 4, strongly agree 5.According to the Turkish adaptation of the scale, the total number of items is 12. This scale measures student satisfaction and self-confidence regarding learning in a simulation environment. The scale consists of two subheadings: "Satisfaction with Current Learning" and "Self-Confidence in Learning." The subheading "Satisfaction with Current Learning" includes 5 items, and the subheading "Self-Confidence in Learning" includes 7 items, with no negatively coded items.
Measured: immediately after the simulation application
Simulation-Based Learning Assessment Scale
The scale has 5 sub-dimensions (nursing process, patient safety, professional information, communication and reflected behavior) and consists of 37 items.All statements on the scale are positive, and there are no negatively coded items. The scale evaluates the essential competencies that a nurse should possess, including the nursing process, patient safety, professional knowledge, communication, and reflective behavior concepts. An increase in the score obtained from the sub-dimensions of the scale indica
Measured: immediately after the simulation application
Secondary outcomes (2)
BREASTFEEDING MANAGEMENT INFORMATION ATTITUDES AND SKILLS EVALUATION FORM
Form of 40 items: 1 Inadequate (0 points 2. Partially Satisfactory/Needs improvement (1 point): 3. Satisfactory (2 points)
Measured: immediately before simulation
BREASTFEEDING MANAGEMENT INFORMATION ATTITUDES AND SKILLS EVALUATION FORM
Form of 40 items: 1 Inadequate (0 points 2. Partially Satisfactory/Needs improvement (1 point): 3. Satisfactory (2 points)
Measured: 4 weeks after the first simulation application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start10 May 2023
- Primary completion10 May 2024
- Study completion10 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Çalışkan, Saglik Bilimleri Universitesi
- Investigators
- yasemin aydın kartal, Assoc. Prof, Study director, SAĞLIK BİLİMLERİ ÜNİVERSİTESİEbru ÇALIŞKAN, PhD.Stu., Principal investigator, SAĞLIK BİLİMLERİ ÜNİVERSİTESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458283
- Sponsor's protocol ID
- BAP2023/18
- Status last verified
- Sep 2024
- First submitted
- 9 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effıcıency Of Hybrıd Based Sımulatıon Method In Breastfeedıng Educatıon Of Mıdwıfery Students
- ClinicalTrials.gov ID
- NCT06458283
- Acronym / sponsor ID
- BAP2023/18
- Conditions
- Breastfeeding, Training Group, Sensitivity, High Fidelity Simulation Training, Medical Simulation, Standardized Patient
- Keywords
- simulation based breastfeeding training, breast feeding, midwifery, education, Simulation, Standardized Patient, High Fidelity Simulation Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 Nov 2024 (estimated)
- First posted
- 13 Jun 2024 (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.
It was planned to determine the effect of hybrid simulation-based breastfeeding training on the practical skills, satisfaction, self-confidence and self-efficacy of the students of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences
Detailed description
This study was planned to determine the effect of hybrid simulation-based breastfeeding education on the practical skills, satisfaction, self-confidence and self-efficacy of the students of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences. The research, planned in a randomized controlled experimental design, will be conducted with Istanbul Health Sciences University Hamidiye Health Sciences Faculty midwifery 2nd year students (N: 84). Students participating in the study will be divided into intervention (n: 42) and control (n: 42) groups according to the computer-assisted simple random sampling technique. Both groups will be given 4 hours of theoretical information about breast milk and breastfeeding education before the application. 42 students assigned to the intervention group will receive training with a high-reality simulator fitted to a standard patient, accompanied by a scenario, and 42 students assigned to the control group will receive practice training with an adult standard patient care model. Introductory Information Form, Simulation-Based Learning Evaluation Scale, Student Satisfaction and Self-Confidence in Learning Scale, Self-Efficacy-Sufficiency Scale, Breastfeeding Management Skill Evaluation Form will be applied to the students participating in the research.
As a result of the findings, discussion and conclusions of the study will be written.
It is important to increase the competency level of midwifery students in breastfeeding management in a simulation environment that creates virtual reality, before the care applied on real patients in a clinical environment. It is recommended to integrate high-reality simulators and standard patient methods into the curriculum in the education of midwifery students . This study aims to increase the application skills, satisfaction, self-confidence and self-efficacy levels of midwifery department students with hybrid simulation-based Breastfeeding education, in which two or more simulation types (standard patient and Lactation Simulator) are combined to produce a more realistic simulation experience.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: hiybrid simulationInvestigation of the effectiveness of scenario-based standardized patient simulation training and breastfeeding management of midwifery students |
| Control Group | Experimental | Other: control grupStandard training of midwifery students with low fidelty breast model |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Having a statement of consent Being a second year midwifery student
Key exclusion criteria (1 listed)
- Wishing to withdraw from the research at any time. Not participating in all simulation applications Incompletely filling out data collection forms
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 |
|---|---|---|
| hiybrid simulationThe intervention group students were given practical training on breast milk and breastfeeding management in the professional skills laboratory, accompanied by a high-reality simulator accompanied by a scenario, and the control group students were given practical training on breast milk and breastfeeding management in the professional skills laboratory, accompanied by an adult standard patient care model. | Other | Experimental Group |
| control gruplow fidelity simulator | Other | Control Group |
Primary outcome
Self-EffectivenessEfficacy Scale
Time frame: immediately before simulation
TThe Self-Efficacy Scale is structured as a 5-point Likert scale consisting of 23 items, with a possible score range of 23 to 115. For each item in the scale, respondents are asked to mark one of the following options: 1) Does not describe me at all, 2) Describes me a little, 3) Neutral, 4) Describes me well, and 5) Describes me very well. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 are scored in reverse. A higher score indicates a higher perception of overall self-efficacy.
Self-EffectivenessEfficacy Scale
Time frame: immediately after the simulation application
The Self-Efficacy Scale is structured as a 5-point Likert scale consisting of 23 items, with a possible score range of 23 to 115. For each item in the scale, respondents are asked to mark one of the following options: 1) Does not describe me at all, 2) Describes me a little, 3) Neutral, 4) Describes me well, and 5) Describes me very well. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 are scored in reverse. A higher score indicates a higher perception of overall self-efficacy.
Self-EffectivenessEfficacy Scale
Time frame: 4 weeks after the first simulation application
The Self-Efficacy Scale is structured as a 5-point Likert scale consisting of 23 items, with a possible score range of 23 to 115. For each item in the scale, respondents are asked to mark one of the following options: 1) Does not describe me at all, 2) Describes me a little, 3) Neutral, 4) Describes me well, and 5) Describes me very well. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 are scored in reverse. A higher score indicates a higher perception of overall self-efficacy.
Introductory Information Form
Time frame: immediately before simulation
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. The Introductory Information Form is in a multiple-choice format consisting of 25 questions by scanning the literature by the researchers.
Student Satisfaction and Self-Confidence Scale in Learning
Time frame: immediately after the simulation application
The scale is a 13-item measurement tool designed to measure student satisfaction with simulation and self-confidence during practices. It is a 5-point Likert type and is scored as strongly disagree 1, disagree 2, undecided 3, agree 4, strongly agree 5.According to the Turkish adaptation of the scale, the total number of items is 12. This scale measures student satisfaction and self-confidence regarding learning in a simulation environment. The scale consists of two subheadings: "Satisfaction with Current Learning" and "Self-Confidence in Learning." The subheading "Satisfaction with Current Learning" includes 5 items, and the subheading "Self-Confidence in Learning" includes 7 items, with no negatively coded items.
Simulation-Based Learning Assessment Scale
Time frame: immediately after the simulation application
The scale has 5 sub-dimensions (nursing process, patient safety, professional information, communication and reflected behavior) and consists of 37 items.All statements on the scale are positive, and there are no negatively coded items. The scale evaluates the essential competencies that a nurse should possess, including the nursing process, patient safety, professional knowledge, communication, and reflective behavior concepts. An increase in the score obtained from the sub-dimensions of the scale indica
2 secondary outcomes
BREASTFEEDING MANAGEMENT INFORMATION ATTITUDES AND SKILLS EVALUATION FORM
Time frame: immediately before simulation
BREASTFEEDING MANAGEMENT INFORMATION ATTITUDES AND SKILLS EVALUATION FORM
Time frame: 4 weeks after the first simulation application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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 aydın kartal, Assoc. Prof study director
SAĞLIK BİLİMLERİ ÜNİVERSİTESİ
Ebru ÇALIŞKAN, PhD.Stu. principal investigator
SAĞLIK BİLİMLERİ ÜNİVERSİTESİ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hiybrid simulation in people with Breastfeeding and Training Group, Sensitivity, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 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?
Results are not available in the source record.
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?
Self-EffectivenessEfficacy Scale (time frame: immediately before simulation). The study lists 6 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 19 Sep 2024.