NCT06722053

Brief Summary

Breastfeeding is the most ideal form of nutrition that concerns the health of mother and baby. The World Health Organization (WHO) recommends that breastfeeding should be started within the first hour after birth. Although breastfeeding has many benefits, research shows that breastfeeding rates are not at the desired level. Breastfeeding self-efficacy, success and adaptation become important to increase breastfeeding rates. In order to provide these components related to breastfeeding, breastfeeding education must be given starting from prenatal period. Education methods have taken different forms in line with the developing technology and the needs of the generation. WHO states that information and communication technology is an opportunity to support breastfeeding. Virtual reality and online learning applications also positively affect learning. New teaching methods, which are increasingly used today, make learning easier and can be used easily in virtual environments. Providing learning by doing in a realistic environment is important for successful breastfeeding and gaining breastfeeding skills and competence. In order to gain breastfeeding skills, the mother can experience breastfeeding during pregnancy using virtual reality technology. While breastfeeding skills are gained through virtual reality, information about breastfeeding can be provided through gamified digital training. With the game, the student actively participates in education. Active participation of the student in gamification ensures that knowledge becomes permanent. It is thought that the effect of the integrative sense can be used to facilitate postpartum remembering of these trainings.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Dec 2024

Typical duration 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

Study Progress77%
Dec 2024Nov 2026

Study Start

First participant enrolled

December 1, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

December 3, 2024

Last Update Submit

December 7, 2024

Conditions

Keywords

breasfeedingvirtual realitygamification

Outcome Measures

Primary Outcomes (3)

  • Breastfeeding Self-Efficacy Scale

    The Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, in 2003, Dennis reduced the scale to 14 items and developed the Breastfeeding Self-Efficacy Scale Short Form. The Turkish validity and reliability of the Breastfeeding Self-Efficacy Scale Short Form was conducted by Aluş Tokat and Okumuş (2010). This scale evaluates how competent mothers feel about breastfeeding. The 14-item scale includes a 5-point Likert-type assessment consisting of the options Not at all sure (1), Not very sure (2), Sometimes sure (3), Sure (4) and Very sure (5). The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score obtained from the scale indicates a high perception of breastfeeding self-efficacy. This scale can be applied in both the antenatal and postnatal periods. The difference between the antenatal form and the postnatal form of the scale is the use of the expression "future tense" in the scale items.

    first day postpartum and thirtieth day postpartum

  • LATCH Diagnostic Scale

    The LATCH Breastfeeding Assessment Tool was created in 1986 by resembling the APGAR scoring system in terms of scoring method. The scale was developed to objectively diagnose breastfeeding, identify breastfeeding problems, plan training, create a common language among healthcare professionals, and be used in research. The scale, which is quick and easy to evaluate, consists of five evaluation criteria. Each item is evaluated between 0 and 2 points. The total possible score is 10 and there is no cut-off point. As the score increases, it is understood that breastfeeding success is high. .

    first day postpartum

  • Breastfeeding Adaptation Scale

    The Breastfeeding Adaptation Scale was developed by Sun Hee Kim (2009). The Turkish validity and reliability were made by Dinçel and Özdilek (2021). Scale items were rated with a 5-point Likert (1 point: Strongly disagree, 2 points: Disagree, 3 points: Undecided, 4 points: Agree, 5 points: Strongly agree). The items in the 6th sub-dimension of the scale, "breastfeeding discomfort", are reverse coded. The score that can be obtained from the scale varies between 27-135. An increase in the total score indicates a high level of breastfeeding adaptation.

    first day postpartum and thirtieth day postpartum

Study Arms (3)

intervention group 1

OTHER

Receiving breastfeeding skills training and gamified digital foundation training with virtual reality.

Other: virtual reality and digital education

intervention group 2

OTHER

With virtual reality breastfeeding skills training, gamified digital-based breastfeeding training will be provided, and in addition, there will be a lemon oil scent in the environment during virtual reality breastfeeding skills training and in the postpartum period.

Other: virtual reality and digital educationOther: virtual reality and digital education and lemon scent

control group

NO INTERVENTION

No training or intervention will be applied and will receive the hospital's standard treatment, care and education.

Interventions

Breastfeeding education through virtual reality and digital education

intervention group 1intervention group 2

virtual reality and digital education and lemon scent inhalation

intervention group 2

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince breastfeeding is done by women, the study will be conducted with women.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • literate,
  • healthy (no systemic/chronic disease, diagnosed psychiatric or neurological disease, no risky pregnancies, etc.)
  • primiparous pregnant women with singleton pregnancies,
  • planning to breastfeed,
  • having an internet-connected smart phone/tablet/computer and being able to use it actively,
  • competent enough to play games and having no problems with their hands, no breast problems that would make breastfeeding difficult (indentation, missing nipple, sore nipple, etc.),
  • no vision, hearing or communication problems,
  • pregnant women who are not allergic to lemon or lemon oil

You may not qualify if:

  • the occurrence of a situation that prevents sucking
  • the baby is not healthy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri City Hospital

Kayseri, 38000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • ipek turhan, master

    Kayseri City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ipek turhan, master

CONTACT

ipek turhan, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The person administering the surveys will not know which group the participants are in, so blinding will be done.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There are two intervention groups and one control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 9, 2024

Study Start

December 1, 2024

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Since the study has not started, it is not planned to be shared at the moment for the confidentiality of the study idea.

Locations