Mixed Reality as a Health Literacy Strategy for Breastfeeding Education

NCT06800521 | Completed

• 1 other identifier: MEDESP-27-2024
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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. 1.Does the mixed reality strategy increase maternal satisfaction with breastfeeding as measured by the Maternal Breastfeeding Evaluation Scale (MBFES)?
2. 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.

Conditions

Breastfeeding Education; Maternal Self-Efficacy; Breastfeeding Satisfaction

Keywords

Breastfeeding; Health Education; Self-Efficacy; Maternal-Child Health

Outcome Measures

Primary Outcomes (2)

• Score on Maternal Breastfeeding Evaluation Scale (MBFES)

  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.

  From enrollment during the third trimester to the end of the first week postpartum

• Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF)

  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.

  From enrollment during the third trimester to the end of the first week postpartum

Secondary Outcomes (1)

• 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.

Study Arms (2)

Mixed Reality Educational Intervention

EXPERIMENTAL

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.

Behavioral: Mixed Reality Breastfeeding Education

Traditional Breastfeeding Counseling

ACTIVE COMPARATOR

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.

Behavioral: Traditional Breastfeeding Counseling

Interventions

Mixed Reality Breastfeeding Education 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.

Mixed Reality Educational Intervention

Traditional Breastfeeding Counseling 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.

Traditional Breastfeeding Counseling

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identified females who are pregnant and meet the inclusion criteria are eligible to participate in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad de la Sabana: lead

Study Sites (1)

Hospital de Sopo

Sopó, Cundinamarca, 251007, Colombia

Location

Related Publications (2)

• 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.

  PMID: 32961461 BACKGROUND

• Montoya-Moncada A, Cuero-Rios L, Rodriguez-Morales F, Perdigon M, Agudelo-Perez S. Exploring the role of mixed reality education in maternal self efficacy and satisfaction with breastfeeding. Sci Rep. 2025 Aug 5;15(1):28484. doi: 10.1038/s41598-025-14319-y.

  PMID: 40764648 DERIVED

MeSH Terms

Conditions

Breast Feeding; Health Education

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Sergio Agudelo-Pérez, PhD. Assitent Proffesor

  Universidad de la Sabana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 30, 2025
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 10, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

CO (1)