Mixed Reality as a Health Literacy Strategy for Breastfeeding Education

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-01-10

Brief Summary

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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.

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Detailed Description

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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

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Breastfeeding Education Maternal Self-Efficacy Breastfeeding Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study uses a parallel assignment model, where participants are randomly assigned to one of two groups: the intervention group receiving a mixed reality-based educational strategy or the control group receiving traditional breastfeeding counseling. Both groups will be followed independently throughout the study period to evaluate and compare outcomes, including breastfeeding satisfaction, self-efficacy, and adherence to exclusive breastfeeding during the first week postpartum. Randomization will ensure comparable baseline characteristics between groups, and the study design allows for the direct evaluation of the intervention's effectiveness.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Due to the nature of the intervention, participants could not be masked to their group assignment. However, the investigators responsible for analyzing the data were masked to the group allocations. This approach ensures that the statistical analysis and interpretation of results remain unbiased, despite the lack of masking at the participant level.

Study Groups

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Mixed Reality Educational Intervention

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.

Group Type EXPERIMENTAL

Mixed Reality Breastfeeding Education

Intervention Type BEHAVIORAL

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.

Traditional Breastfeeding Counseling

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.

Group Type ACTIVE_COMPARATOR

Traditional Breastfeeding Counseling

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes