Metaverse- and VR-Supported Education in a Digital Breast... | NCT07516041

NCT07516041

Status Module

Description Module

Detailed Description

Breastfeeding is the most ideal method for ensuring infants' healthy growth and nutrition and is a public health priority due to its short- and long-term health benefits. Emerging technologies in the 21st century have added new dimensions to educational processes, and tools such as virtual reality (VR) and the Metaverse support traditional educational methods by offering multimodal learning opportunities. The literature indicates that the use of VR in breastfeeding education is limited, and no Metaverse-based studies have been reported.

This study represents a prospective follow-up of a randomized controlled trial conducted between July 2023 and April 2024 in three hospitals. In the previous study, 53 primiparous pregnant women-who were attending antenatal classes for the first time in their third trimester and had no prior breastfeeding experience-were randomly assigned to an intervention group (n=28) and a control group (n=25). In the new prospective study, 20 mothers from each group were reached, resulting in a total of 40 participants who continued to be followed in their originally assigned groups.

Participants in the intervention group received Metaverse- and VR-supported breastfeeding education in a digital breastfeeding museum consisting of multiple educational rooms. They explored the museum through personalized avatars using VR headsets, accessing educational content that included photo frames, written boards, and instructional videos. The control group continued to receive routine antenatal breastfeeding education at the participating hospitals. In the prospective follow-up, no additional postnatal interventions were applied; data were collected only on long-term outcomes at four postnatal periods: 0-6 months, 6-12 months, 12-18 months, and 18-24 months. Data collection tools included maternal and infant demographic forms, a breastfeeding knowledge questionnaire, the Breastfeeding Motivation Scale, the Breastfeeding Self-Efficacy Scale-Short Form, and the Breastfeeding Problems Assessment Scale. Participants were contacted by phone, and data were collected via online surveys.

This study is the first to prospectively evaluate the long-term effects of Metaverse- and VR-supported digital breastfeeding education on postnatal breastfeeding practices, self-efficacy, and motivation. It provides evidence on the sustained impact of technology-based educational models on breastfeeding behavior.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Routine Antenatal Class Education Program Group	No Intervention	In the previous randomized controlled study, 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. In the prospective follow-up study, no additional postnatal education was provided; only long-term follow-up data were collected at four postpartum periods: 0-6 months, 6-12 months, 12-18 months, and 18-24 months.
Training Supported by Metaverse and VR in the Digital Breastfeeding Museum Group	Experimental	In the previous randomized controlled study, pregnant women in this group received Metaverse- and virtual reality (VR)-supported education in a digital breastfeeding museum. The sole intervention consisted of a digital breastfeeding education program delivered via virtual reality and Metaverse platforms. All content was provided exclusively through head-mounted VR devices, without the need for any pharmacological agents or invasive procedures. The environment was explored by participants using virtual reality (VR) headsets (Meta Quest 2). In the prospective follow-up study, no additional postnatal education was provided; only long-term follow-up data were collected at four postpartum periods: 0-6 months, 6-12 months, 12-18 months, and 18-24 months.	Other: Training Supported by Metaverse and Virtual Reality (VR) in the Digital Breastfeeding Museum Group Device: Virtual Reality Headset (Meta Quest 2)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Training Supported by Metaverse and Virtual Reality (VR) in the Digital Breastfeeding Museum Group	Other	In the previous randomized controlled study, pregnant women in this group received Metaverse- and virtual reality (VR)-supported education in a digital breastfeeding museum. The sole intervention consisted of a digital breastfeeding education program delivered via virtual reality and Metaverse platforms. All content was provided exclusively through head-mounted VR devices, without the need for any pharmacological agents or invasive procedures. The environment was explored by participants using virtual reality (VR) headsets (Meta Quest 2). In the prospective follow-up study, no additional postnatal education was provided; only long-term follow-up data were collected at four postpartum periods: 0-6 months, 6-12 months, 12-18 months, and 18-24 months.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Breastfeeding Motivation Scale	The Breastfeeding Motivation Scale was developed by Kestler-Peleg and colleagues in 2015. It is a 24-item, five-point Likert-type scale with five subscales. Cronbach's alpha coefficients for the subscales range from 0.56 to 0.89. The validity and reliability of the scale for the Turkish population were tested by Mızrak in 2017 among primiparous and multiparous women.The Turkish version of the Breastfeeding Motivation Scale for primiparous women consists of 23 items, five subscales, and uses a four-point Likert format. The subscales are: (1) integrated regulation, (2) intrinsic motivation - identified regulation, (3) introjected regulation - social approval, (4) introjected regulation - social pressure, and (5) external regulation - instrumental needs. The scale does not have a total score; subscale scores are evaluated individually. A higher score on a subscale indicates greater motivation in the domain represented by that subscale.	Assessed during ongoing breastfeeding up to 24 months 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.	0-6 months, 6-12 months, 12-18 months, and 18-24 months postpartum
Breastfeeding Problems Assessment Scale	The Breastfeeding Problems Assessment Scale was developed by Karen Wambach in 1990. The validity and reliability of the Turkish version were established by Uyanık in 2019, with a Cronbach's alpha of 0.776. Turkish form consists only of the first section, containing 18 items across five subscales: mechanical concerns, process concerns, insufficient milk concerns, nipple concerns, and social concerns. Items are scored as follows: 1 = none, 2 = mild, 3 = moderate, 4 = severe, 5 = unbearable. Total scores range from 18 to 90, with higher scores indicating more severe breastfeeding problems. The scale has been reported as a valid tool for the Turkish population. In the present study, Cronbach's alpha was found to be 0.83.

Eligibility Module