The Effect of Hybrid Simulation-Based Lactation Consultancy Training on the Skills of Midwifery Students

July 25, 2024 updated by: YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34668
        • University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 25, 2024

Last Verified

July 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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