Breastfeeding Simulation in Prenatal Education

NCT06701227 | Completed

• 1 other identifier: 4.324.588
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding Self-Efficacy; Exclusive Breastfeeding

Keywords

Breast Feeding; Simulation Training; Health Education; Prenatal Education

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  At 2 months after delivery

Study Arms (2)

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.

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.

Interventions

In Situ Simulation 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.

In Situ Simulation

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Municipal Health Department

Jaboticabal, São Paulo, 14870-590, Brazil

Location

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

• Luciana Mara Monti Fonseca, RN, PhD

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 22, 2024
• Study Start: October 26, 2022
• Primary Completion: May 22, 2023
• Study Completion: November 24, 2023
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)