NCT07078825

Brief Summary

This randomized controlled study aimed to evaluate the effect of Metaverse- and virtual reality (VR)-supported education provided in a digital breastfeeding museum on breastfeeding knowledge level, self-efficacy, and breastfeeding success in primiparous pregnant women. The study population consisted of primiparous women who applied for the first time to the antenatal classes of three hospitals in Turkey between July 2023 and April 2024 during their third trimester and had no prior breastfeeding experience. A total of 53 primiparous pregnant women were randomly assigned to the intervention group (n=28) and the control group (n=25). While the intervention group received Metaverse- and VR-supported breastfeeding education in the digital breastfeeding museum, the control group received standard antenatal education provided in routine antenatal classes. Data were collected using a questionnaire assessing participant satisfaction and breastfeeding knowledge, the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), and the LATCH Breastfeeding Assessment Tool. Assessments were performed at three time points: before the intervention, after the intervention, and postpartum.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

July 12, 2025

Last Update Submit

July 22, 2025

Conditions

Keywords

Breastfeeding Knowledge Level, Breastfeeding Success

Outcome Measures

Primary Outcomes (3)

  • Breastfeeding Knowledge Score

    In order to assess mothers' breastfeeding knowledge levels, a 25-item knowledge questionnaire was developed based on a review of the literature. Each question was scored on a 4-point scale, with the total score ranging from 0 to 100. Participants' responses to the questionnaire were evaluated by assigning points only to correct answers. Incorrect, "I don't know," or unanswered items were not scored. Each participant's total knowledge score was calculated based on the number of correct responses, and the knowledge level was treated as a continuous variable. In this study, no cut-off point was defined to categorize participants as "knowledgeable" or "not knowledgeable"; therefore, knowledge level was interpreted based on the increase in total score.

    Immediately before the education, immediately after the education, and within the first 24 hours postpartum

  • Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF) Score

    The Breastfeeding Self-Efficacy Scale is used to assess how confident mothers feel about their ability to breastfeed. The original scale was developed in 1999. In 2003, the scale was shortened to a 14-item version known as the Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF), which is recommended for use in research and practice. The BSES-SF is a 5-point Likert-type scale, with responses ranging from 1 ("Not at all confident") to 5 ("Always confident"). The minimum possible score is 14, and the maximum is 70. Higher scores indicate higher levels of breastfeeding self-efficacy. The Turkish validity and reliability study of the scale was conducted in 2010. In this study, the Cronbach's alpha coefficient was reported as 0.86.

    Immediately before the education, immediately after the education, and within the first 24 hours postpartum

  • LATCH Breastfeeding Assessment Tool Score

    The LATCH Breastfeeding Assessment Tool is used to evaluate whether breastfeeding mothers are correctly breastfeeding their infants. The acronym LATCH represents five assessment criteria based on the initial letters of the following components: * L (Latch on the breast): How well the infant latches onto the breast * A (Audible swallowing): Audible swallowing sounds from the infant * T (Type of nipple): The type of the mother's nipple * C (Comfort breast/nipple): The mother's level of breast/nipple comfort * H (Hold): The mother's positioning and ability to hold the baby during breastfeeding Each item is scored on a scale from 0 to 2, with a maximum total score of 10. Higher scores indicate greater breastfeeding success. The reliability of the Turkish version of the scale was reported with a Cronbach's alpha coefficient of 0.95.

    Within the first 24 hours postpartum

Study Arms (2)

Routine Antenatal Class Education Program Group

NO INTERVENTION

No additional intervention was administered to the pregnant women in this group; they only received the routine breastfeeding education provided by the antenatal education program.

Training Supported by Metaverse and VR in the Digital Breastfeeding Museum Group

EXPERIMENTAL

The pregnant women in this group received training supported by Metaverse and virtual reality (VR) in the digital breastfeeding museum. No additional drugs or medical devices were used throughout the study. The sole intervention consisted of a digital breastfeeding educational program delivered via virtual reality and Metaverse platforms. All content was accessed exclusively through head-mounted displays, without the need for any pharmacological agents or invasive procedures.The environment was explored by participants using virtual reality (VR) headsets (Meta Quest 2).

Other: Training Supported by Metaverse and Virtual Reality (VR) in the Digital Breastfeeding Museum Group

Interventions

The pregnant women in this group received training supported by Metaverse and virtual reality (VR) in the digital breastfeeding museum. The training began when pregnant women wore VR headsets (Meta Quest 2) and entered the digital museum using hand controllers. To prevent physical risks like falling or bumping, they navigated the environment safely from where they were seated. Educational content was accessed via personalized avatars. Participants moved between rooms by walking virtually or clicking on circular transition portals. The researcher provided guidance when needed. Video durations varied by topic, totaling around 40 minutes. Mothers could rewatch videos and pause/resume the training on the same day. They engaged with visual, auditory, and written materials, spending approximately one hour in the museum.

Training Supported by Metaverse and VR in the Digital Breastfeeding Museum Group

Eligibility Criteria

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

You may qualify if:

  • Primiparous pregnant women who have never given live birth or had any breastfeeding experience and who were attending antenatal classes for the first time during their third trimester,
  • Pregnant women who voluntarily agreed to participate in the study,
  • Pregnant women aged 18 years or older,
  • Pregnant women who are literate in Turkish,
  • Mothers who gave birth to newborns with normal gestational age and birth weight.

You may not qualify if:

  • Pregnant women with physical conditions preventing them from breastfeeding,
  • Pregnant women with any condition that would prevent them from completing the questionnaire (e.g., intellectual disability, illiteracy),
  • Pregnant women who have difficulty communicating (e.g., with hearing, speech, or visual impairments),
  • Pregnant women with any illness that may affect milk secretion or breastfeeding (e.g., cancer, active tuberculosis),
  • Pregnant women taking medications that may interfere with breastfeeding,
  • Mothers whose newborns have conditions that could interfere with sucking (e.g., cleft lip/palate, being on mechanical ventilation, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa, Nilufer, 16059

Bursa, Nilufer, 16059, Turkey (Türkiye)

Location

Related Publications (1)

  • Kilic U, Arar M, Oruc MA. The effect of virtual reality on the breastfeeding process: a randomized controlled study. J Perinatol. 2024 Nov;44(11):1611-1616. doi: 10.1038/s41372-024-02077-0. Epub 2024 Jul 31.

    PMID: 39085438BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistician performing the data analysis was blinded to the participants' group assignments to prevent bias. No masking was applied; both participants and researchers were aware of the intervention.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study was designed as a randomized controlled trial consisting of two parallel groups: an intervention group receiving Metaverse- and VR-supported education in the digital breastfeeding museum, and a control group receiving standard antenatal class education.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

July 12, 2025

First Posted

July 22, 2025

Study Start

July 1, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data (IPD) may be shared upon reasonable request."

Available IPD Datasets

Publication (39085438)Access

Locations