Breastfeeding Consultancy TrainingNCT06528795
The Effect of Hybrid Simulation-Based Lactation Consultancy Training on the Skills of Midwifery Students
A study testing Scenario-based high-reality hybrid simulation method in people with Breastfeeding Consultancy Training, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This research was planned to examine the effects of hybrid simulation-based breastfeeding consultancy training on midwifery students' psychosocial care competence and communication skills. 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
- Breastfeeding Consultancy Training
- What is being tested?
- Scenario-based high-reality hybrid simulation method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 30 Sep 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in research.
- Being an active student in the second year of the University of Health Sciences, Hamidiye Faculty of Health Sciences, Department of Midwifery.
Who cannot join
- -Being a passive student in the second year of the University of Health Sciences, Hamidiye Faculty of Health Sciences, Department of Midwifery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hybrid Simulation-Based Lactation Consultancy Training on Midwifery Students' Psychosocial Care Competence and Communication Skills
This research was planned to examine the effects of hybrid simulation-based breastfeeding consultancy training on midwifery students' psychosocial care competence and communication skills. The research population will consist of second-year students studying at Health Sciences University (SBU), Hamidiye Faculty of Health Sciences (HSBF), Department of Midwifery in the spring semester of the 2023-2024 academic year (N: 80). 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. Control group students will practice on a simple breast model within the scope of classical education. "Descriptive Information Form", "Psychosocial Care Competency Self-Assessment Scale" and "Communication Skills Scale-Adult Form" will be applied to the students participating in the research.
- Conditions
- Breastfeeding Consultancy Training
- Being tested
- Scenario-based high-reality hybrid simulation method
- Keywords
- Hybrid Simulation, Midwifery Students, Psychosocial Care Competence, Communication Skill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scenario-based high-reality hybrid simulation methodOther
Intervention group students will be practiced with the "Lactation Simulator", a high-reality simulator, in the simulation laboratory, accompanied by a scenario.
| Study group | Role | What they receive |
|---|---|---|
| İntervention group (n:40) | Experimental | Intervention group students will be practiced with the "Lactation Simulator", a high-reality simulator, in the simulation laboratory, accompanied by a scenario.
Lactation Simulation Model (LSM) is a high fidelity simulator and is an applied and wearable breastfeeding model that educators can use for interactive training. LSM can be worn like a t-shirt and is placed over the shoulders and placed on the chest, then secured with a seat belt from the back. Thus, the seat belt can be adjusted for every size and weight. LSM is a simulator with the ability to respond to hand manipulation.
Thanks to this feature, simulated milk release occurs when pressure is applied to the breast tissue, which is approximately 3 cm behind both nipples. It is also a suitable model for expressing milk by hand or with a pump. LSM has four different skin tones. The fact that LSM can be applied on clothing contributes significantly to the protection of privacy. Receives: Other: Scenario-based high-reality hybrid simulation method |
| Control group (n:40) | No intervention | Control group students will practice on a simple breast model within the scope of classical education. Simple Breast Model: Can be used to teach and practice breast palpation techniques. The breast has real female breast size, skin color and elastic softness. Institutional permission will be requested for the "Simple breast model" in the basic skills laboratory of the Midwifery Department of Hamidiye Faculty of Health Sciences. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
In this form, created by the researchers based on the literature, the participants' age, high school they graduated from, previous simulation training, etc. questions are included.
Measured: 10 minutes
Psychosocial Care Competence Self-Assessment Scale
The scale was developed by Karataş and Kelleci in 2020. The four-dimensional scale, which consists of 18 valid and reliable items and is called "symptom identification", "use of information", "intervention" and "diagnosis", is a 5-point Likert type. Item, internal consistency and test-retest analyzes were used for the reliability of the scale and it was determined that the internal consistency coefficient was 0.93 and its sub-dimensions were between 0.80 - 0.93.
Measured: 10 minutes
Communication Skills Scale-Adult Form
The form of the scale used for adults was created by Korkut Owen and Demirbaş-Çelik (2017) by adapting it to the communication skills scale. The scale consists of 25 items and 5 sub-dimensions. The first subscale, consisting of nine items, is called basic skills and self-expression. The second sub-dimension is called paying attention to communication and consists of five items. The third sub-dimension, called willingness to establish relationships, consists of three items. The fourth sub-dimension, called active listening and non-verbal communication, consists of five items. The last sub-dimension, compliance with communication principles, consists of three items. Cronbach's alpha coefficient was calculated for the internal consistency reliability of the scale and the internal consistency coefficient of the scale was found to be .94.
Measured: 10 minutes
Secondary outcomes (2)
Psychosocial Care Competence Self-Assessment Scale
The scale was developed by Karataş and Kelleci in 2020. The four-dimensional scale, which consists of 18 valid and reliable items and is called "symptom identification", "use of information", "intervention" and "diagnosis", is a 5-point Likert type. Item, internal consistency and test-retest analyzes were used for the reliability of the scale and it was determined that the internal consistency coefficient was 0.93 and its sub-dimensions were between 0.80 - 0.93.
Measured: 10 minutes
Communication Skills Scale-Adult Form
The form of the scale used for adults was created by Korkut Owen and Demirbaş-Çelik (2017) by adapting it to the communication skills scale. The scale consists of 25 items and 5 sub-dimensions. The first subscale, consisting of nine items, is called basic skills and self-expression. The second sub-dimension is called paying attention to communication and consists of five items. The third sub-dimension, called willingness to establish relationships, consists of three items. The fourth sub-dimension, called active listening and non-verbal communication, consists of five items. The last sub-dimension, compliance with communication principles, consists of three items. Cronbach's alpha coefficient was calculated for the internal consistency reliability of the scale and the internal consistency coefficient of the scale was found to be .94.
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 posted30 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding Consultancy TrainingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
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
- NCT06528795
- Sponsor's protocol ID
- SBÜ-AYDINKARTAL-006
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 30 Jul 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 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hybrid Simulation-Based Lactation Consultancy Training on Midwifery Students' Psychosocial Care Competence and Communication Skills
- ClinicalTrials.gov ID
- NCT06528795
- Acronym / sponsor ID
- SBÜ-AYDINKARTAL-006
- Conditions
- Breastfeeding Consultancy Training
- Keywords
- Hybrid Simulation, Midwifery Students, Psychosocial Care Competence, Communication Skill
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 30 Jul 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.
This research was planned to examine the effects of hybrid simulation-based breastfeeding consultancy training on midwifery students' psychosocial care competence and communication skills. The research population will consist of second-year students studying at Health Sciences University (SBU), Hamidiye Faculty of Health Sciences (HSBF), Department of Midwifery in the spring semester of the 2023-2024 academic year (N: 80). 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. Control group students will practice on a simple breast model within the scope of classical education. "Descriptive Information Form", "Psychosocial Care Competency Self-Assessment Scale" and "Communication Skills Scale-Adult Form" will be applied to the students participating in the research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Quasi-experimental randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| İntervention group (n:40) | Experimental | Other: Scenario-based high-reality hybrid simulation methodIntervention group students will be practiced with the "Lactation Simulator", a high-reality simulator, in the simulation laboratory, accompanied by a scenario. Lactation Simulation Model (LSM) is a high fidelity simulator and is an applied and wearable breastfeeding model that educators can use for interactive training. LSM can be worn like a t-shirt and is placed over the shoulders and placed on the chest, then secured with a seat belt from the back. Thus, the seat belt can be adjusted for every size and weight. LSM is a simulator with the ability to respond to hand manipulation. Thanks to this feature, simulated milk release occurs when pressure is applied to the breast tissue, which is approximately 3 cm behind both nipples. It is also a suitable model for expressing milk by hand or with a pump. LSM has four different skin tones. The fact that LSM can be applied on clothing contributes significantly to the protection of privacy. |
| Control group (n:40) | No intervention | –Control group students will practice on a simple breast model within the scope of classical education. Simple Breast Model: Can be used to teach and practice breast palpation techniques. The breast has real female breast size, skin color and elastic softness. Institutional permission will be requested for the "Simple breast model" in the basic skills laboratory of the Midwifery Department of Hamidiye Faculty of Health Sciences. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteering to participate in research.
- Being an active student in the second year of the University of Health Sciences, Hamidiye Faculty of Health Sciences, Department of Midwifery.
Key exclusion criteria (1 listed)
- -Being a passive student in the second year of the University of Health Sciences, Hamidiye Faculty of Health Sciences, Department of Midwifery.
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-reality hybrid simulation methodIntervention group students will be practiced with the "Lactation Simulator", a high-reality simulator, in the simulation laboratory, accompanied by a scenario. | Other | İntervention group (n:40) |
Primary outcome
Introductory Information Form
Time frame: 10 minutes
In this form, created by the researchers based on the literature, the participants' age, high school they graduated from, previous simulation training, etc. questions are included.
Psychosocial Care Competence Self-Assessment Scale
Time frame: 10 minutes
The scale was developed by Karataş and Kelleci in 2020. The four-dimensional scale, which consists of 18 valid and reliable items and is called "symptom identification", "use of information", "intervention" and "diagnosis", is a 5-point Likert type. Item, internal consistency and test-retest analyzes were used for the reliability of the scale and it was determined that the internal consistency coefficient was 0.93 and its sub-dimensions were between 0.80 - 0.93.
Communication Skills Scale-Adult Form
Time frame: 10 minutes
The form of the scale used for adults was created by Korkut Owen and Demirbaş-Çelik (2017) by adapting it to the communication skills scale. The scale consists of 25 items and 5 sub-dimensions. The first subscale, consisting of nine items, is called basic skills and self-expression. The second sub-dimension is called paying attention to communication and consists of five items. The third sub-dimension, called willingness to establish relationships, consists of three items. The fourth sub-dimension, called active listening and non-verbal communication, consists of five items. The last sub-dimension, compliance with communication principles, consists of three items. Cronbach's alpha coefficient was calculated for the internal consistency reliability of the scale and the internal consistency coefficient of the scale was found to be .94.
2 secondary outcomes
Psychosocial Care Competence Self-Assessment Scale
Time frame: 10 minutes
Communication Skills Scale-Adult Form
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 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.
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 Scenario-based high-reality hybrid simulation method in people with Breastfeeding Consultancy Training, 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 2 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 30 Jul 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?
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 30 Jul 2024.