NCT06267157

Brief 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 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.

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
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 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

January 3, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

January 3, 2024

Last Update Submit

February 18, 2024

Conditions

Keywords

BreastfeedingMetaverseNursingVirtual Reality

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    5 mounth

Study Arms (2)

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.

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.

Other: theoretical breastfeeding training

Interventions

Group that will receive breastfeeding training with virtual glasses, in the metaverse universe.

virtual reality training

Classic 2-hour theoretical breastfeeding training with ppt

theoretical breastfeeding training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Withdrawing from the research voluntarily
  • Not participating in the stages of the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Faculty of Nursing

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Gülten Güvenc

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 3, 2024

First Posted

February 20, 2024

Study Start

March 20, 2024

Primary Completion

May 20, 2024

Study Completion

July 2, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations