Breast FeedingNCT06267157
Breastfeeding Consultant Training in the Metvaverse Universe
A study testing virtual reality training and theoretical breastfeeding training in people with Breast Feeding, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
Although breastfeeding is an important and natural process in infant development, mothers may fail to manage the process. Nurses, who have an important place in helping to physically initiate and maintain breastfeeding, provide an in-depth knowledge of breast anatomy and breastfeeding physiology, practice and process… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- What is being tested?
- virtual reality training and theoretical breastfeeding training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2024to 2 Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Volunteering to participate in research
- Not having received formal training on breastfeeding
- No vision or hearing problems
- Not having a motion sensitive disease (e.g. Vertigo).
Who cannot join
- Withdrawing from the research voluntarily
- Not participating in the stages of the research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Faculty of Nursing
Ankara
Gulten Guvenc, gulten.guvenc@sbu.edu.tr
About this study
Official title: Evaluation of the Effect of the Breastfeeding Counseling Education Model Developed in the Metaverse Universe on the Counseling Skills, Knowledge and Empathy Levels of Nursing Students
Although breastfeeding is an important and natural process in infant development, mothers may fail to manage the process. Nurses, who have an important place in helping to physically initiate and maintain breastfeeding, provide an in-depth knowledge of breast anatomy and breastfeeding physiology, practice and process breastfeeding techniques. Must have extensive management skills. Although the World Health Organization recommends that breastfeeding issues should be addressed in medical, nursing and midwifery schools, there is a lack of nurses' training curricula and breastfeeding training given in hospitals. Due to this deficiency, mothers have low self-confidence and insufficient knowledge about breastfeeding.
The aim of this project is to develop a breastfeeding counseling model in the metaverse universe and to determine the effect of this model on nursing students' breastfeeding counseling skills, knowledge level and empathy skills. Giving breastfeeding education with the metaverse application compared to the application on real patients includes much less risk for the patient and the ability to practice until the right skill is acquired. In the project, it is expected that the breastfeeding counseling education model (LactaVerse), which is structured on virtual reality developed in the metaverse universe, is compared to the existing deficient and non-standardized breastfeeding education practice, enabling nurses to practice more and without errors during the undergraduate education, and to gain more effective skills in breastfeeding counseling. In this context, the project will support the ability of multiple users in the metaverse universe to examine the anatomy of the breast and apply breastfeeding counseling to the mother by transmitting their voices and movements with virtual glasses.
Read more
In the preparation phase of the training to be developed in the virtual universe within the scope of the project, the breast anatomical modeling and the breastfeeding mother-baby duo project scenario will be developed and virtual glasses will be transferred. At this stage, expert opinions of the questionnaires to be used in the evaluation of educational effectiveness will be taken. Pre-application of data collection tools and LactaVerse training will be made. Experiment (n=40) and control (n=40) groups will be determined from the students by randomization. "Descriptive Characteristics Data Collection Form", "Breastfeeding Information Form", "Basic Empathy Level Scale", "Nursing Counseling Skill Scale" and "Presence Scale" will be applied to both groups. During the application phase, Lactaverse training method with virtual glasses will be applied to the experimental group, and a 2-hour theoretical classical training method will be applied to the control group. After 4 weeks of the training, the post-tests will be applied to the experimental group and the control group and they counseling will be given to the patient who plays the role of a nursing mother in the laboratory, and measurements will be made with the Breastfeeding Counseling Skill List and statistical analyzes will be applied.
With the training developed in connection with the project, it is expected that nurses will have a high level of empathy development and breastfeeding counseling skills in a complex healthcare environment such as breastfeeding counseling before they graduate. In this way, the professional knowledge, counseling skills and empathy skills of nurses, who have an important role in breastfeeding, will increase, helping our society to increase the breastfeeding rates to the desired level.
- Conditions
- Breast Feeding
- Being tested
- virtual reality training, theoretical breastfeeding training
- Keywords
- Breastfeeding, Metaverse, Nursing, Virtual Reality
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality trainingDevice
Group that will receive breastfeeding training with virtual glasses, in the metaverse universe.
theoretical breastfeeding trainingOther
Classic 2-hour theoretical breastfeeding training with ppt
| Study group | Role | What they receive |
|---|---|---|
| virtual reality training | Experimental | Data Collection Forms will be administered face to face to nursing students before training. LactaVerse will be introduced to the students in the experimental group. After the introduction and information are given, virtual reality glasses, lenses and pupil distances will be adjusted and placed on their heads. Each student will be given a disposable goggle mask. Students will then be asked to use their devices in a virtual environment; In the first breastfeeding room, the patient will be asked to touch the entire anatomy, including the breast tissue, ductus, and areola, and examine every angle with the finger. In the next stage; The patient will be asked to go to the second breastfeeding room and assist the mother and baby there. In this room, the student will be expected to complete the skill steps without skipping. He/she will not be able to proceed to the next application without making the correct application. Receives: Device: virtual reality training |
| theoretical breastfeeding training | Other | This group will receive 2 hours of theoretical breastfeeding training. Model dolls and breasts will be used in theoretical education by applying the classical education model. Entrance Data Collection Form, Breastfeeding Information Form, Basic Empathy Level Scale, Nursing Counseling Skills Scale and Presence Scale will be applied to the students whose informed consent form has been obtained. Receives: Other: theoretical breastfeeding training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Features Data Collection Form
The form prepared by the researchers consists of 2 parts and a total of 13 questions. In the first part, there are 8 questions about the socio-demographic characteristics of the students, and in the second part, there are 5 questions questioning their computer game playing situations and virtual reality application experiences.
Measured: 5 mounth
Breastfeeding Information Form
This form consists of 25 questions to be answered as true, false and unknown in 5 subgroups. Each correct answer is worth 4 points, with the highest 100 and the lowest 0 points. As the score obtained from the form increases, the level of breastfeeding knowledge will be interpreted as increasing. After the preparation of this form, it was revised by taking expert opinions from 10 faculty members working in the field. The reliability of the information form will be measured by the Kuder Richardson 20 (KR-20) test.
Measured: 5 mounth
Basic Empathy Level Scale
This scale is a 5-point Likert-type graded, two-factor, and 20-item scale. It consists of a total of 20 items, 9 items measure cognitive empathy and 11 items measure emotional empathyFor the cognitive empathy subscale, the lowest score that can be obtained from the scale is 9 and the highest score is 45. For the emotional empathy subscale, the lowest score that can be obtained from the scale is 11 and the highest score is 55. Since there is no cut-off point in the scale scoring, it is used in comparison studies. The higher the score obtained from the scale determines the higher the basic empathy level.
Measured: 5 mounth
Breastfeeding Teaching Skill Evaluation Form
It will be scored on whether the student doing the breastfeeding counseling is able to demonstrate the skill. There are 25 digits in the Skill List.
Correct application will be evaluated as 2, incomplete application will be evaluated as 1, inability to apply will be evaluated as 0 points, and the maximum score to be obtained from the list is 50 and the minimum score is 0.
Measured: 5 mounth
Presence Scale
his scale has 5 sub-dimensions and 5-point Likert type. The sub-dimensions of the scale were determined as Participation, Adaptation/Containment, Sensory Commitment, Interaction and Interface Quality. It is assumed that as the scores obtained from the sub-dimensions increase, the experienced virtual environment is perceived in a more realistic structure and the sense of presence is at a higher level.
Measured: 5 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start20 Mar 2024 (estimated)
- Primary completion20 May 2024 (estimated)
- Study completion2 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Ceylan, Ankara Medipol University
- Investigators
- Gülten Güvenc, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267157
- Sponsor's protocol ID
- 2023/23
- Status last verified
- Feb 2024
- First submitted
- 3 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the Breastfeeding Counseling Education Model Developed in the Metaverse Universe on the Counseling Skills, Knowledge and Empathy Levels of Nursing Students
- ClinicalTrials.gov ID
- NCT06267157
- Acronym / sponsor ID
- 2023/23
- Conditions
- Breast Feeding
- Keywords
- Breastfeeding, Metaverse, Nursing, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 2 Jul 2024 (estimated)
- First posted
- 20 Feb 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.
Although breastfeeding is an important and natural process in infant development, mothers may fail to manage the process. Nurses, who have an important place in helping to physically initiate and maintain breastfeeding, provide an in-depth knowledge of breast anatomy and breastfeeding physiology, practice and process breastfeeding techniques. Must have extensive management skills. Although the World Health Organization recommends that breastfeeding issues should be addressed in medical, nursing and midwifery schools, there is a lack of nurses' training curricula and breastfeeding training given in hospitals. Due to this deficiency, mothers have low self-confidence and insufficient knowledge about breastfeeding.
The aim of this project is to develop a breastfeeding counseling model in the metaverse universe and to determine the effect of this model on nursing students' breastfeeding counseling skills, knowledge level and empathy skills. Giving breastfeeding education with the metaverse application compared to the application on real patients includes much less risk for the patient and the ability to practice until the right skill is acquired. In the project, it is expected that the breastfeeding counseling education model (LactaVerse), which is structured on virtual reality developed in the metaverse universe, is compared to the existing deficient and non-standardized breastfeeding education practice, enabling nurses to practice more and without errors during the undergraduate education, and to gain more effective skills in breastfeeding counseling. In this context, the project will support the ability of multiple users in the metaverse universe to examine the anatomy of the breast and apply breastfeeding counseling to the mother by transmitting their voices and movements with virtual glasses.
In the preparation phase of the training to be developed in the virtual universe within the scope of the project, the breast anatomical modeling and the breastfeeding mother-baby duo project scenario will be developed and virtual glasses will be transferred. At this stage, expert opinions of the questionnaires to be used in the evaluation of educational effectiveness will be taken. Pre-application of data collection tools and LactaVerse training will be made. Experiment (n=40) and control (n=40) groups will be determined from the students by randomization. "Descriptive Characteristics Data Collection Form", "Breastfeeding Information Form", "Basic Empathy Level Scale", "Nursing Counseling Skill Scale" and "Presence Scale" will be applied to both groups. During the application phase, Lactaverse training method with virtual glasses will be applied to the experimental group, and a 2-hour theoretical classical training method will be applied to the control group. After 4 weeks of the training, the post-tests will be applied to the experimental group and the control group and they counseling will be given to the patient who plays the role of a nursing mother in the laboratory, and measurements will be made with the Breastfeeding Counseling Skill List and statistical analyzes will be applied.
With the training developed in connection with the project, it is expected that nurses will have a high level of empathy development and breastfeeding counseling skills in a complex healthcare environment such as breastfeeding counseling before they graduate. In this way, the professional knowledge, counseling skills and empathy skills of nurses, who have an important role in breastfeeding, will increase, helping our society to increase the breastfeeding rates to the desired level.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality training | Experimental | Device: virtual reality trainingData Collection Forms will be administered face to face to nursing students before training. LactaVerse will be introduced to the students in the experimental group. After the introduction and information are given, virtual reality glasses, lenses and pupil distances will be adjusted and placed on their heads. Each student will be given a disposable goggle mask. Students will then be asked to use their devices in a virtual environment; In the first breastfeeding room, the patient will be asked to touch the entire anatomy, including the breast tissue, ductus, and areola, and examine every angle with the finger. In the next stage; The patient will be asked to go to the second breastfeeding room and assist the mother and baby there. In this room, the student will be expected to complete the skill steps without skipping. He/she will not be able to proceed to the next application without making the correct application. |
| theoretical breastfeeding training | Other | Other: theoretical breastfeeding trainingThis group will receive 2 hours of theoretical breastfeeding training. Model dolls and breasts will be used in theoretical education by applying the classical education model. Entrance Data Collection Form, Breastfeeding Information Form, Basic Empathy Level Scale, Nursing Counseling Skills Scale and Presence Scale will be applied to the students whose informed consent form has been obtained. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteering to participate in research
- Not having received formal training on breastfeeding
- No vision or hearing problems
- Not having a motion sensitive disease (e.g. Vertigo).
Key exclusion criteria (2 listed)
- Withdrawing from the research voluntarily
- Not participating in the stages of the research
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 |
|---|---|---|
| virtual reality trainingGroup that will receive breastfeeding training with virtual glasses, in the metaverse universe. | Device | virtual reality training |
| theoretical breastfeeding trainingClassic 2-hour theoretical breastfeeding training with ppt | Other | theoretical breastfeeding training |
Primary outcome
Introductory Features Data Collection Form
Time frame: 5 mounth
The form prepared by the researchers consists of 2 parts and a total of 13 questions. In the first part, there are 8 questions about the socio-demographic characteristics of the students, and in the second part, there are 5 questions questioning their computer game playing situations and virtual reality application experiences.
Breastfeeding Information Form
Time frame: 5 mounth
This form consists of 25 questions to be answered as true, false and unknown in 5 subgroups. Each correct answer is worth 4 points, with the highest 100 and the lowest 0 points. As the score obtained from the form increases, the level of breastfeeding knowledge will be interpreted as increasing. After the preparation of this form, it was revised by taking expert opinions from 10 faculty members working in the field. The reliability of the information form will be measured by the Kuder Richardson 20 (KR-20) test.
Basic Empathy Level Scale
Time frame: 5 mounth
This scale is a 5-point Likert-type graded, two-factor, and 20-item scale. It consists of a total of 20 items, 9 items measure cognitive empathy and 11 items measure emotional empathyFor the cognitive empathy subscale, the lowest score that can be obtained from the scale is 9 and the highest score is 45. For the emotional empathy subscale, the lowest score that can be obtained from the scale is 11 and the highest score is 55. Since there is no cut-off point in the scale scoring, it is used in comparison studies. The higher the score obtained from the scale determines the higher the basic empathy level.
Breastfeeding Teaching Skill Evaluation Form
Time frame: 5 mounth
It will be scored on whether the student doing the breastfeeding counseling is able to demonstrate the skill. There are 25 digits in the Skill List. Correct application will be evaluated as 2, incomplete application will be evaluated as 1, inability to apply will be evaluated as 0 points, and the maximum score to be obtained from the list is 50 and the minimum score is 0.
Presence Scale
Time frame: 5 mounth
his scale has 5 sub-dimensions and 5-point Likert type. The sub-dimensions of the scale were determined as Participation, Adaptation/Containment, Sensory Commitment, Interaction and Interface Quality. It is assumed that as the scores obtained from the sub-dimensions increase, the experienced virtual environment is perceived in a more realistic structure and the sense of presence is at a higher level.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
Gülten Güvenc study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality training and theoretical breastfeeding training in people with Breast Feeding, run by Gulhane School of Medicine 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 2 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 20 Feb 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?
Contact Sinem ceylan (5338186689, ceylansinem1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Features Data Collection Form (time frame: 5 mounth). The study lists 5 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 20 Feb 2024.