NCT06528795

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

Same day

First QC Date

July 25, 2024

Last Update Submit

July 25, 2024

Conditions

Keywords

Hybrid SimulationMidwifery StudentsPsychosocial Care CompetenceCommunication Skill

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    10 minutes

Secondary Outcomes (2)

  • Psychosocial Care Competence Self-Assessment Scale

    10 minutes

  • Communication Skills Scale-Adult Form

    10 minutes

Study Arms (2)

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.

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.

Interventions

Intervention group students will be practiced with the "Lactation Simulator", a high-reality simulator, in the simulation laboratory, accompanied by a scenario.

İntervention group (n:40)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Being a passive student in the second year of the University of Health Sciences, Hamidiye Faculty of Health Sciences, Department of Midwifery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Istanbul, 34668, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Quasi-experimental randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

July 25, 2024

First Posted

July 30, 2024

Study Start

September 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 30, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations