Mixed Reality As a Health Literacy Strategy for Breastfeeding Education: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de la Sabana
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Score on Maternal Breastfeeding Evaluation Scale (MBFES)
Study Overview
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:
- Does the mixed reality strategy increase maternal satisfaction with breastfeeding as measured by the Maternal Breastfeeding Evaluation Scale (MBFES)?
- 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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).
Arms & Interventions
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.
Intervention: Mixed Reality Breastfeeding Education (Behavioral)
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.
Intervention: Traditional Breastfeeding Counseling (Behavioral)
Outcomes
Primary Outcomes
Score on Maternal Breastfeeding Evaluation Scale (MBFES)
Time Frame: 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)
Time Frame: 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 Outcomes
- 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.)
Investigators
sergio Ivan agudelo Perez
Assistant Professor
Universidad de la Sabana