Clinical trial NCT06701227: Breastfeeding Simulation in Prenatal Education
Official title: In Situ Simulation in Prenatal Breastfeeding Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding Self-Efficacy
Exclusive Breastfeeding
Keywords: Breast Feeding
Simulation Training
Health Education
Prenatal Education
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* Pregnant people registered at a FHU in the city in their third trimester of pregnancy.

Exclusion Criteria:

* Present with a pre-existing health condition that constitutes a permanent contraindication for breastfeeding (people infected with HIV, HTLV1, or HTLV2).

Primary outcomes:
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
timeFrame: At baseline (pre-test), immediately after educational intervention/in situ simulation (immediate post-test) and 2 months after childbirth (follow-up post-test)
measure: 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
timeFrame: At 2 months after delivery
measure: 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
timeFrame: At 2 months after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Jaboticabal
country: Brazil
facility: Municipal Health Department
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Luciana Mara Monti Fonseca, RN, PhD
role: STUDY_CHAIR
References: