NCT06800521

Mixed Reality as a Health Literacy Strategy for Breastfeeding Education

Mixed Reality as a Health Literacy Strategy for Breastfeeding Education: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Universidad de la Sabana · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this randomized controlled trial is to evaluate whether a mixed reality-based educational strategy improves breastfeeding satisfaction and self-efficacy in pregnant women compared to traditional counseling. The study will involve women in their third trimester of pregnancy who are attending prenatal care in Sopó, Colombia. The main questions it aims to answer are: 1. Does the mixed reality strategy increase maternal satisfaction with breastfeeding as measured by the Maternal Breastfeeding Evaluation Scale (MBFES)? 2. Does the mixed reality strategy enhance breastfeeding self-efficacy as measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)? Researchers will compare the mixed reality intervention to traditional counseling to see if it leads to higher satisfaction, self-efficacy, and adherence to exclusive breastfeeding during the first week of life. Participants will: Receive either traditional counseling or the mixed reality educational intervention. Complete self-reported surveys on breastfeeding satisfaction and self-efficacy at one week and one month postpartum. Participate in follow-up calls to report breastfeeding practices, specifically adherence to exclusive breastfeeding during the first week postpartum. This study aims to provide new insights into using innovative educational strategies to improve breastfeeding outcomes.

Detailed description

This study is a randomized controlled trial designed to assess the impact of a mixed reality-based educational intervention on breastfeeding satisfaction and self-efficacy in pregnant women during their third trimester. The research will be conducted in Sopó, Colombia, where breastfeeding rates remain below recommended levels. The study aims to address key barriers, including maternal uncertainty and lack of confidence, which often hinder exclusive breastfeeding practices. Participants will be randomly assigned to one of two groups: Mixed Reality Intervention Group: This group will receive the traditional breastfeeding counseling offered during prenatal classes, supplemented by an innovative mixed reality educational strategy. This technology blends real-world scenarios with virtual elements, providing participants with a simulated breastfeeding experience. The intervention includes the use of mixed reality goggles, realistic breastfeeding mannequins, and immersive audio-visual tools to enhance learning and build confidence. Traditional Counseling Group: This group will receive standard breastfeeding counseling as part of their routine prenatal care. The primary outcomes of the study include: Breastfeeding Satisfaction: Assessed using the Maternal Breastfeeding Evaluation Scale (MBFES), which evaluates maternal enjoyment, satisfaction with breastfeeding, and perceptions of the baby's growth and lifestyle adjustments. Breastfeeding Self-Efficacy: Measured using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), focusing on maternal confidence, intention, and perceived capability to breastfeed successfully. The secondary outcome will evaluate the percentage of newborns exclusively breastfed during the first week of life, measured through self-reported data collected via follow-up phone calls. The study seeks to leverage the advantages of mixed reality technology to provide a practical, immersive, and emotionally engaging learning experience. It is anticipated that this approach will better prepare mothers for the challenges of breastfeeding, increase their confidence, and ultimately improve adherence to exclusive breastfeeding practices. By comparing these two approaches, the trial aims to generate evidence that could inform future educational strategies, both locally and globally, for promoting breastfeeding and improving maternal and infant health outcomes.

Conditions

• Breastfeeding Education
• Maternal Self-Efficacy
• Breastfeeding Satisfaction

Interventions

Type	Name	Description
BEHAVIORAL	Mixed Reality Breastfeeding Education	Mixed Reality Breastfeeding Education: This intervention includes an innovative mixed reality-based educational strategy combined with traditional breastfeeding counseling. Participants use mixed reality goggles to experience immersive breastfeeding scenarios, interact with audio-visual materials tailored for breastfeeding education, and engage with realistic breastfeeding simulations. The session is delivered once during the third trimester of pregnancy and lasts approximately 90 minutes. This intervention is designed to improve maternal confidence, satisfaction, and adherence to exclusive breastfeeding through an engaging and practical learning environment.
BEHAVIORAL	Traditional Breastfeeding Counseling	This intervention involves standard prenatal breastfeeding education provided by trained healthcare professionals. Participants receive verbal and visual explanations of breastfeeding techniques, benefits, and solutions to common challenges. Delivered in a single session during the third trimester of pregnancy, the session lasts approximately 60 minutes and represents the current standard of care in breastfeeding education.

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-12-01
• Completion: 2025-01-10
• First posted: 2025-01-30
• Last updated: 2025-01-30

Locations

1 site across 1 country: Colombia