Clinical trial NCT06800521: Mixed Reality as a Health Literacy Strategy for Breastfeeding Education
Official title: Mixed Reality as a Health Literacy Strategy for Breastfeeding Education: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding Education
Maternal Self-Efficacy
Breastfeeding Satisfaction
Keywords: Breastfeeding
Health Education
Self-Efficacy
Maternal-Child Health
Lead sponsor: Universidad de la Sabana
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Score on Maternal Breastfeeding Evaluation Scale (MBFES)
timeFrame: From enrollment during the third trimester to the end of the first week postpartum
measure: Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF)
timeFrame: From enrollment during the third trimester to the end of the first week postpartum
Secondary outcomes:
measure: Percentage of Neonates Exclusively Breastfed at Discharge and During the First Week of Life
timeFrame: From enrollment during the third trimester to the end of the first week postpartum.
Other outcomes:
Locations:
city: Sopo
country: Colombia
facility: Hospital de Sopo
state: Cundinamarca
Study officials:
affiliation: Universidad de la Sabana
name: Sergio Agudelo-Pérez, PhD. Assitent Proffesor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tseng JF, Chen SR, Au HK, Chipojola R, Lee GT, Lee PH, Shyu ML, Kuo SY. Effectiveness of an integrated breastfeeding education program to improve self-efficacy and exclusive breastfeeding rate: A single-blind, randomised controlled study. Int J Nurs Stud. 2020 Nov;111:103770. doi: 10.1016/j.ijnurstu.2020.103770. Epub 2020 Sep 3.