Breastfeeding Self-EfficacyNCT06701227
Breastfeeding Simulation in Prenatal Education
A study testing In Situ Simulation in people with Breastfeeding Self-Efficacy and Exclusive Breastfeeding, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Breastfeeding education should be initiated during pregnancy. Simulation is an effective educational technique that has been little explored in the context of prenatal education. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breastfeeding Self-Efficacy, Exclusive Breastfeeding
- What is being tested?
- In Situ Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Oct 2022to 24 Nov 2023
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant people registered at a FHU in the city in their third trimester of pregnancy.
Who cannot join
- Present with a pre-existing health condition that constitutes a permanent contraindication for breastfeeding (people infected with HIV, HTLV1, or HTLV2).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Situ Simulation in Prenatal Breastfeeding Education
Breastfeeding education should be initiated during pregnancy. Simulation is an effective educational technique that has been little explored in the context of prenatal education.
This study aims to evaluate the feasibility and effectiveness of an in situ simulation scenario about breastfeeding, as a prenatal educational intervention at home, on breastfeeding self-efficacy and related outcomes.
Read the detailed description
According to the World Health Organization, breastfeeding should be initiated within the first hour of life, being exclusive for children up to six months of age, complemented and continued for up to two years or more. However, despite the countless benefits of human milk for both maternal and child health and for society as a whole, establishing and maintaining breastfeeding, in accordance with international guidelines, is still a challenge. Low breastfeeding rates can be observed in several countries around the world.
Breastfeeding education should be initiated during prenatal care. Studies indicate that high quality education throughout prenatal care is a protective factor for the success of breastfeeding. However, pregnant people are not always properly advised about breastfeeding. Most of the times, breastfeeding education in prenatal care is carried out through traditional teaching methods, which are more based on behavioral education and do not encourage an individual's autonomy in the teaching-learning process.
On the other hand, experiential learning is more related to constructive education, by encouraging the co-creation of a learning environment, where the teacher/nurse becomes a facilitator based on the learner's needs. Clinical simulation is an educational technique that promotes an active learning experience, through the imitation of reality in a safe and controlled environment, being able to increase participant's knowledge, skills, confidence, and clinical judgment. Among the existing simulation modalities, in situ simulation stands out as the one that takes place in the real environment (hospitals, outpatient clinics, and community). In situ simulation has several specific advantages from an educational and economic point of view.
Simulation has already been used in breastfeeding teaching. Some studies describe and evaluate the use of simulation-based education to teach breastfeeding to undergraduate and postgraduate students, as well as for lactation support providers training. Multiple types of simulation have been used to teach breastfeeding, including hybrid simulation, Objective Structured Clinical Examination, telesimulation and virtual simulation.
However, there is little literature exploring the use of simulation for the education of patients. Usually, experiences using simulators to teach pregnant and postpartum people about breastfeeding do not consist of structured and validated scenarios, focusing only on demonstrating the breastfeeding technique with low-fidelity simulators. There are no studies in the literature about in situ simulation scenarios created specifically for patients and implemented in the community.
Based on Bandura's theory of self-efficacy, first, it is necessary for pregnant people to believe that they are capable of breastfeeding and then seek resources, internal or external, to assist them in this practice. The following sources of information support breastfeeding self-efficacy: personal experience; observational or vicarious experience; verbal persuasion and emotional and physiological state, with personal experience considered the main source of information for self-efficacy. Therefore, a simulation scenario could be able to promote a personal breastfeeding experience for pregnant people, although simulated, yet highly realistic.
Therefore, this study aims to evaluate the feasibility and effectiveness of an in situ simulation scenario about breastfeeding, previously created and validated with experts, specifically for pregnant people, as a prenatal educational intervention at home, on breastfeeding self-efficacy and related outcomes (exclusive breastfeeding rate and breastfeeding related difficulties at 2 months after childbirth).
- Being tested
- In Situ Simulation
- Keywords
- Breast Feeding, Simulation Training, Health Education, Prenatal Education
- 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.
In Situ SimulationOther
The simulation scenario included briefing (5 min), scenario (10 min), and debriefing (20 min).
Materials and Simulators: neonatal mannequin, with its crying controlled by a smartphone; breastfeeding simulator that had the function of ejecting liquid imitating human milk.
Team: One facilitator and one actor playing a Community Health Worker.
| Study group | Role | What they receive |
|---|---|---|
| In Situ Simulation | Experimental | The educational intervention consists of applying the in situ simulation scenario entitled "Breastfeeding the Newborn", previously structured and validated among experts, through individual home visits, with pregnant people. Receives: Other: In Situ Simulation |
| Routine Prenatal Care | No intervention | Routine prenatal guidance on breastfeeding. Currently, prenatal education provided by the Unified Health System (UHS) is being carried out through individual counseling during prenatal consultations and in groups for pregnant people organized by the FHUs and also by the local maternity hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of breastfeeding self-efficacy measured by applications of the Brazilian-Portuguese version of the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) from baseline to 2 months after delivery
The BSES-SF is a scale consisting of 14 items, using a 5-point Likert scale, that measures a person's self-confidence in their abilities to breastfeed. The total score can range from 14 to 70 points, with 14 representing the lowest level of self-efficacy and 70 the highest possible, further divided into: low efficacy (14-32 points), medium efficacy (33-51 points), and high efficacy (52-70 points) (Dennis, 2003). The results will be presented as the mean scores of the BSES-SF, which will be statistically analyzed and compared
Measured: At baseline (pre-test), immediately after educational intervention/in situ simulation (immediate post-test) and 2 months after childbirth (follow-up post-test)
Exclusive breastfeeding rate (number of babies who are being fed exclusively with breast milk, and no other liquids or solids, except in specific cases such as vitamins, mineral supplements, or medications) by a self-developed questionnaire
The self-developed questionnaire was reviewed by 2 experts in clinical simulation and breastfeeding, and it was administered by the principal investigator to the study participants
Measured: At 2 months after delivery
Breastfeeding difficulties (number of lactating people who faced difficulties such as nipple trauma, breast engorgement, mastitis, breast abscess, low milk production, ineffective sucking and others) by a self-developed questionnaire
The self-developed questionnaire was reviewed by 2 experts in clinical simulation and breastfeeding, and it was administered by the principal investigator to the study participants
Measured: At 2 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start26 Oct 2022
- Primary completion22 May 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding Self-EfficacyStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taison Regis Penariol Natarelli, University of Sao Paulo
- Investigators
- Luciana Mara Monti Fonseca, RN, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701227
- Sponsor's protocol ID
- 4.324.588
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Situ Simulation in Prenatal Breastfeeding Education
- ClinicalTrials.gov ID
- NCT06701227
- Acronym / sponsor ID
- 4.324.588
- Keywords
- Breast Feeding, Simulation Training, Health Education, Prenatal Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 22 Nov 2024 (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.
Breastfeeding education should be initiated during pregnancy. Simulation is an effective educational technique that has been little explored in the context of prenatal education.
This study aims to evaluate the feasibility and effectiveness of an in situ simulation scenario about breastfeeding, as a prenatal educational intervention at home, on breastfeeding self-efficacy and related outcomes.
Detailed description
According to the World Health Organization, breastfeeding should be initiated within the first hour of life, being exclusive for children up to six months of age, complemented and continued for up to two years or more. However, despite the countless benefits of human milk for both maternal and child health and for society as a whole, establishing and maintaining breastfeeding, in accordance with international guidelines, is still a challenge. Low breastfeeding rates can be observed in several countries around the world.
Breastfeeding education should be initiated during prenatal care. Studies indicate that high quality education throughout prenatal care is a protective factor for the success of breastfeeding. However, pregnant people are not always properly advised about breastfeeding. Most of the times, breastfeeding education in prenatal care is carried out through traditional teaching methods, which are more based on behavioral education and do not encourage an individual's autonomy in the teaching-learning process.
On the other hand, experiential learning is more related to constructive education, by encouraging the co-creation of a learning environment, where the teacher/nurse becomes a facilitator based on the learner's needs. Clinical simulation is an educational technique that promotes an active learning experience, through the imitation of reality in a safe and controlled environment, being able to increase participant's knowledge, skills, confidence, and clinical judgment. Among the existing simulation modalities, in situ simulation stands out as the one that takes place in the real environment (hospitals, outpatient clinics, and community). In situ simulation has several specific advantages from an educational and economic point of view.
Simulation has already been used in breastfeeding teaching. Some studies describe and evaluate the use of simulation-based education to teach breastfeeding to undergraduate and postgraduate students, as well as for lactation support providers training. Multiple types of simulation have been used to teach breastfeeding, including hybrid simulation, Objective Structured Clinical Examination, telesimulation and virtual simulation.
However, there is little literature exploring the use of simulation for the education of patients. Usually, experiences using simulators to teach pregnant and postpartum people about breastfeeding do not consist of structured and validated scenarios, focusing only on demonstrating the breastfeeding technique with low-fidelity simulators. There are no studies in the literature about in situ simulation scenarios created specifically for patients and implemented in the community.
Based on Bandura's theory of self-efficacy, first, it is necessary for pregnant people to believe that they are capable of breastfeeding and then seek resources, internal or external, to assist them in this practice. The following sources of information support breastfeeding self-efficacy: personal experience; observational or vicarious experience; verbal persuasion and emotional and physiological state, with personal experience considered the main source of information for self-efficacy. Therefore, a simulation scenario could be able to promote a personal breastfeeding experience for pregnant people, although simulated, yet highly realistic.
Therefore, this study aims to evaluate the feasibility and effectiveness of an in situ simulation scenario about breastfeeding, previously created and validated with experts, specifically for pregnant people, as a prenatal educational intervention at home, on breastfeeding self-efficacy and related outcomes (exclusive breastfeeding rate and breastfeeding related difficulties at 2 months after childbirth).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In Situ Simulation | Experimental | Other: In Situ SimulationThe educational intervention consists of applying the in situ simulation scenario entitled "Breastfeeding the Newborn", previously structured and validated among experts, through individual home visits, with pregnant people. |
| Routine Prenatal Care | No intervention | –Routine prenatal guidance on breastfeeding. Currently, prenatal education provided by the Unified Health System (UHS) is being carried out through individual counseling during prenatal consultations and in groups for pregnant people organized by the FHUs and also by the local maternity hospital. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant people registered at a FHU in the city in their third trimester of pregnancy.
Key exclusion criteria (1 listed)
- Present with a pre-existing health condition that constitutes a permanent contraindication for breastfeeding (people infected with HIV, HTLV1, or HTLV2).
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 |
|---|---|---|
| In Situ SimulationThe simulation scenario included briefing (5 min), scenario (10 min), and debriefing (20 min). Materials and Simulators: neonatal mannequin, with its crying controlled by a smartphone; breastfeeding simulator that had the function of ejecting liquid imitating human milk. Team: One facilitator and one actor playing a Community Health Worker. | Other | In Situ Simulation |
Primary outcome
Change of breastfeeding self-efficacy measured by applications of the Brazilian-Portuguese version of the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) from baseline to 2 months after delivery
Time frame: At baseline (pre-test), immediately after educational intervention/in situ simulation (immediate post-test) and 2 months after childbirth (follow-up post-test)
The BSES-SF is a scale consisting of 14 items, using a 5-point Likert scale, that measures a person's self-confidence in their abilities to breastfeed. The total score can range from 14 to 70 points, with 14 representing the lowest level of self-efficacy and 70 the highest possible, further divided into: low efficacy (14-32 points), medium efficacy (33-51 points), and high efficacy (52-70 points) (Dennis, 2003). The results will be presented as the mean scores of the BSES-SF, which will be statistically analyzed and compared
Exclusive breastfeeding rate (number of babies who are being fed exclusively with breast milk, and no other liquids or solids, except in specific cases such as vitamins, mineral supplements, or medications) by a self-developed questionnaire
Time frame: At 2 months after delivery
The self-developed questionnaire was reviewed by 2 experts in clinical simulation and breastfeeding, and it was administered by the principal investigator to the study participants
Breastfeeding difficulties (number of lactating people who faced difficulties such as nipple trauma, breast engorgement, mastitis, breast abscess, low milk production, ineffective sucking and others) by a self-developed questionnaire
Time frame: At 2 months after delivery
The self-developed questionnaire was reviewed by 2 experts in clinical simulation and breastfeeding, and it was administered by the principal investigator to the study participants
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 22 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Luciana Mara Monti Fonseca, RN, PhD study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In Situ Simulation in people with Breastfeeding Self-Efficacy and Exclusive Breastfeeding, run by University of Sao Paulo at 1 site in Brazil.
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 1 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 22 Nov 2024. 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 Brazil. 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?
Change of breastfeeding self-efficacy measured by applications of the Brazilian-Portuguese version of the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) from baseline to 2 months after delivery (time frame: At baseline (pre-test), immediately after educational intervention/in situ simulation (immediate post-test) and 2 months after childbirth (follow-up post-test)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2024.