Mixed Reality As a Health Literacy Strategy for Breastfeeding Education

Universidad de la Sabana

Status: Completed

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

Treatments: Behavioral: Mixed Reality Breastfeeding Education; Behavioral: Traditional Breastfeeding Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT06800521

MEDESP-27-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Mixed Reality Educational Intervention

Experimental group

Description:

Participants in this arm will receive a mixed reality-based educational intervention, including: Mixed Reality Goggles: Simulating breastfeeding scenarios. Immersive Audio-Visual Materials: Enhancing engagement and understanding. Realistic Breastfeeding Simulations: Providing hands-on practice to build confidence. Delivered in a single session during the third trimester, this intervention aims to improve breastfeeding satisfaction and self-efficacy. Follow-Up: Satisfaction and self-efficacy will be assessed using MBFES and BSES-SF. Exclusive breastfeeding adherence will be monitored during the first postpartum week.

Treatment:

Behavioral: Mixed Reality Breastfeeding Education

Traditional Breastfeeding Counseling

Active Comparator group

Description:

Participants in this arm will receive traditional breastfeeding counseling as part of routine prenatal care. The session includes verbal and visual education by trained healthcare professionals, focusing on breastfeeding techniques, benefits, and solutions to common challenges. Delivered during the third trimester, this approach represents the standard of care. Follow-Up: Breastfeeding satisfaction and self-efficacy will be assessed using MBFES and BSES-SF. Adherence to exclusive breastfeeding will be monitored during the first postpartum week.

Treatment:

Behavioral: Traditional Breastfeeding Counseling