- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06528795
The Effect of Hybrid Simulation-Based Lactation Consultancy Training on the Skills of Midwifery Students
The Effect of Hybrid Simulation-Based Lactation Consultancy Training on Midwifery Students' Psychosocial Care Competence and Communication Skills
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34668
- University of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
-Being a passive student in the second year of the University of Health Sciences, Hamidiye Faculty of Health Sciences, Department of Midwifery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: İntervention group (n:40)
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. |
Intervention group students will be practiced with the "Lactation Simulator", a high-reality simulator, in the simulation laboratory, accompanied by a scenario.
|
|
No Intervention: Control group (n:40)
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10 minutes
|
|
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.
|
10 minutes
|
|
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.
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10 minutes
|
|
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.
|
10 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SBÜ-AYDINKARTAL-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breastfeeding Consultancy Training
-
Cumhuriyet UniversityRecruitingPrimigravida Women | Breastfeeding Self-Efficacy | Breastfeeding Consultancy Training | Mother-Infant AttachmentTurkey (Türkiye)
-
Fundacion Profesor Novoa SantosNot yet recruitingGrowth & Development | Breastfeeding, Exclusive | Breastfeeding Rate | Breastfeeding Outcomes | Breastfeeding Duration | Breastfeeding After Discharge From Hospital Following Childbirth, Yes/no | Breastfeeding Attitude | Breastfeeding Support System | Breastfeeding Consultancy Training | Breastfeeding...Spain
-
LiquidGoldConceptUniversity of MichiganCompletedBreastfeeding | Patient Simulation | High Fidelity Simulation TrainingUnited States
-
Saglik Bilimleri UniversitesiActive, not recruitingBreastfeeding | Training Group, Sensitivity | High Fidelity Simulation Training | Medical Simulation | Standardized PatientTurkey
-
Uludag UniversityCompletedVirtual Reality | Breastfeeding Education | Breastfeeding Duration | Breastfeeding Self-Efficacy | Metaverse | Breastfeeding Motivation | Digital Museum | Breastfeeding Problems AssessmentTurkey (Türkiye)
-
Marmara UniversityNot yet recruitingBreastfeeding | Breastfeeding Support
-
Halic UniversityCompletedBreastfeeding | Breastfeeding, ExclusiveTurkey
-
University of Ontario Institute of TechnologyDurham Region Health DepartmentUnknown
-
University of California, DavisUniversity of California, San Francisco; Public Hospital Roatan, HondurasCompletedBreastfeeding | Breastfeeding, ExclusiveHonduras
-
T.C. ORDU ÜNİVERSİTESİCompletedBreastfeeding Education | Breastfeeding Attitude | Breastfeeding Self-EfficacyTurkey
Clinical Trials on Scenario-based high-reality hybrid simulation method
-
Saglik Bilimleri UniversitesiCompleted
-
Chimei Medical CenterCompletedVirtual Reality | High Fidelity Simulation TrainingTaiwan
-
Istanbul Saglik Bilimleri UniversityNot yet recruitingNurse's Role | Simulation of Physical IllnessTurkey
-
Seoul National University HospitalActive, not recruitingHypoxia | AnaphylaxisSouth Korea
-
Zonguldak Bulent Ecevit UniversityNurten Taşdemir Assoc. Prof. PhD.UnknownCardiopulmonary Resuscitation | Nurse's Role | Simulation TrainingTurkey
-
Karadeniz Technical UniversityActive, not recruitingSimulation TrainingTurkey (Türkiye)
-
tygh backupCompletedNursing EducationTaiwan
-
Hiroshima UniversityCompletedNursing Education | Teaching MethodBangladesh
-
Marmara UniversityNot yet recruitingNursing Students | Urinary Catheterization