Mixed Reality As a Health Literacy Strategy for Breastfeeding Education

Not Applicable

Completed

• Conditions: Breastfeeding Education; Maternal Self-Efficacy; Breastfeeding Satisfaction

• Registration Number: NCT06800521
• Lead Sponsor: Universidad de la Sabana

Brief 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.

Study Timeline

• Study Start: 2024-06-01
• Primary Completion: 2024-12-01
• Status Verified: 2025-01
• Study Completion: 2025-01-10
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-01-30
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

Pregnant women in their third trimester enrolled in the prenatal care program. Aged 18 years or older, hemodynamically stable, conscious, and oriented.

Exclusion Criteria

Pregnant or postpartum women and newborns with contraindications for breastfeeding (e.g., HIV positive, HTLV 1 or 2 positive, or undergoing chemotherapy for cancer).

Pregnant or postpartum women with intellectual or sensory disabilities. Newborns with congenital, anatomical malformations, or conditions that affect breastfeeding.

Admission of the mother or newborn to the neonatal intensive care unit (NICU).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Score on Maternal Breastfeeding Evaluation Scale (MBFES)	From enrollment during the third trimester to the end of the first week postpartum	Maternal Breastfeeding Evaluation Scale (MBFES): This scale includes 30 items assessing maternal enjoyment, satisfaction, infant growth, and maternal lifestyle. Responses are scored on a scale from 1 (strongly disagree) to 5 (strongly agree), with reverse scoring for negatively worded items. Total scores range from 30 to 150, with higher scores indicating greater breastfeeding satisfaction.
Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF)	From enrollment during the third trimester to the end of the first week postpartum	Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF): This scale consists of 14 items evaluating maternal confidence, effort, thought patterns, and physical and psychological well-being. Responses range from 1 (never) to 5 (always), with total scores ranging from 14 to 70. Higher scores indicate greater self-efficacy in breastfeeding.

Secondary Outcome Measures

Name	Time	Method
Percentage of Neonates Exclusively Breastfed at Discharge and During the First Week of Life	From enrollment during the third trimester to the end of the first week postpartum.	The secondary outcome is the percentage of neonates exclusively breastfed during two specific time points: At Discharge from Rooming-In: Mothers will report the type of feeding their newborns received during the hospital stay, focusing on exclusive breastfeeding without formula or other supplements.; During the First Week of Life: A follow-up phone call will collect self-reported data on feeding practices during the first week postpartum, identifying whether the neonate was exclusively breastfed or received other feedings (e.g., formula or water).; Exclusive breastfeeding is defined according to WHO guidelines, where the infant receives only breast milk, with no other liquids or solids except for oral rehydration solutions or medicines. The data will be analyzed to calculate the proportion of neonates exclusively breastfed at these two critical points.

Trial Locations

Locations (1)

Hospital de Sopo; 🇨🇴 Sopo, Cundinamarca, Colombia