Breastfeeding EducationNCT06800521
Mixed Reality as a Health Literacy Strategy for Breastfeeding Education
A study testing Mixed Reality Breastfeeding Education and Traditional Breastfeeding Counseling in people with Breastfeeding Education and Maternal Self-Efficacy, run by Universidad de la Sabana at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Education, Maternal Self-Efficacy, Breastfeeding Satisfaction
- What is being tested?
- Mixed Reality Breastfeeding Education and Traditional Breastfeeding Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jun 2024to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women in their third trimester enrolled in the prenatal care program. Aged 18 years or older, hemodynamically stable, conscious, and oriented.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Mixed Reality as a Health Literacy Strategy for Breastfeeding Education: A Randomized Controlled Trial
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:
Read more
- 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.
Read the 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.
- Being tested
- Mixed Reality Breastfeeding Education, Traditional Breastfeeding Counseling
- Keywords
- Breastfeeding, Health Education, Self-Efficacy, Maternal-Child Health
- Medical subject headings
- Breast Feeding, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Reality Breastfeeding EducationBehavioural
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 CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Traditional Breastfeeding Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The secondary outcome is the percentage of neonates exclusively breastfed during two specific time points:
At Discharge from Rooming-In:
Mothers will report the type of feeding their newborns received during the hospital stay, focusing on exclusive breastfeeding without formula or other supplements.
During the First Week of Life:
A follow-up phone call will collect self-reported data on feeding practices during the first week postpartum, identifying whether the neonate was exclusively breastfed or received other feedings (e.g., formula or water).
Exclusive breastfeeding is defined according to WHO guidelines, where the infant receives only breast milk, with no other liquids or solids except for oral rehydration solutions or medicines. The data will be analyzed to calculate the proportion of neonates exclusively breastfed at these two critical points.
Measured: From enrollment during the third trimester to the end of the first week postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Jun 2024
- Primary completion1 Dec 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de la Sabana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sergio Ivan agudelo Perez, Universidad de la Sabana
- Investigators
- Sergio Agudelo-Pérez, PhD. Assitent Proffesor, Principal investigator, Universidad de la Sabana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800521
- Sponsor's protocol ID
- MEDESP-27-2024
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32961461Montoya-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.
PubMed 40764648
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed Reality as a Health Literacy Strategy for Breastfeeding Education: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06800521
- Acronym / sponsor ID
- MEDESP-27-2024
- Keywords
- Breastfeeding, Health Education, Self-Efficacy, Maternal-Child Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Universidad de la SabanaUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mixed Reality Educational Intervention | Experimental | Behavioral: Mixed Reality Breastfeeding EducationParticipants 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. |
| Traditional Breastfeeding Counseling | Active comparator | Behavioral: Traditional Breastfeeding CounselingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women in their third trimester enrolled in the prenatal care program. Aged 18 years or older, hemodynamically stable, conscious, and oriented.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed Reality Breastfeeding EducationMixed 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. | Behavioural | Mixed Reality Educational Intervention |
| Traditional Breastfeeding CounselingThis 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. | Behavioural | Traditional Breastfeeding Counseling |
Primary outcome
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.
1 secondary outcome
Percentage of Neonates Exclusively Breastfed at Discharge and During the First Week of Life
Time frame: From enrollment during the third trimester to the end of the first week postpartum.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Results publication: PubMed 32961461Tseng 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.
- Derived from this study: PubMed 40764648Montoya-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Agudelo-Pérez, PhD. Assitent Proffesor principal investigator
Universidad de la Sabana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed Reality Breastfeeding Education and Traditional Breastfeeding Counseling in people with Breastfeeding Education and Maternal Self-Efficacy, run by Universidad de la Sabana at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on Maternal Breastfeeding Evaluation Scale (MBFES) (time frame: From enrollment during the third trimester to the end of the first week postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06800521, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.