Breastfeeding Simulation in Prenatal Education

NCT ID: NCT06701227

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2023-11-24

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).

Conditions

Breastfeeding Self-Efficacy; Exclusive Breastfeeding

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

In Situ Simulation

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.

Group Type: EXPERIMENTAL

In Situ Simulation

Intervention Type: OTHER

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.

Routine Prenatal Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

In Situ Simulation

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.

Intervention Type: OTHER

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).

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Taison Regis Penariol Natarelli

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luciana Mara Monti Fonseca, RN, PhD

Role: STUDY_CHAIR

University of Sao Paulo

Locations

Municipal Health Department

Jaboticabal, São Paulo, Brazil

Countries

Brazil

Other Identifiers

4.324.588

Identifier Type: -

Identifier Source: org_study_id