Effect of a breastfeeding educational intervention: a randomized controlled trial*

Objective: to assess the effect of a breastfeeding educational intervention on the counseling provided to postpartum women. Method: this is a randomized controlled trial including 104 postpartum women (intervention group = 52 and control group = 52) from a private hospital, whose educational intervention was based on the pragmatic theory and on the use of a soft-hard technology called Breastfeeding Educational Kit (Kit Educativo para Aleitamento Materno, KEAM). Women were followed-up for up to 60 days after childbirth. Chi-Squared Test, Fischer’s Exact Test, and Generalized Estimating Equation were used, with a significance level of 5% (p-value <0.05). The analyses were performed using the Statistical Package for the Social Sciences, version 24. Results: the postpartum women in the intervention group had fewer breastfeeding difficulties and a higher percentage of exclusive breastfeeding at all time points compared with those in the control group. Conclusion: the educational intervention based on active methodologies and stimulating instructional resources was effective in developing greater practical mastery among postpartum women with regard to adherence and maintenance of exclusive breastfeeding. Registry REBEC RBR – 8p9v7v.


Introduction
The World Health Organization (1) recommends exclusive breastfeeding (EBF) up to six months of the infant's life and supplemental breastfeeding up to two years of age and beyond, since it is directly related to health promotion and prevention of infant morbidity and mortality. However, many women face difficulties regarding the practical management of breastfeeding and/or associated with external factors, which implies the discontinuation of this protective behavior.
Thus, the implementation of innovative strategies and technological resources in the field of health education may greatly contribute to women's learning in order to strengthen engagement in preventive behaviors and to promote BF.
In this sense, it is understood that the concept of Health Technologies encompasses any form of intervention used to promote, prevent, diagnose, or treat diseases, as well as to promote rehabilitation or short-, medium-, and long-term care, including devices, procedures, medications, materials, programs, and care protocols, in addition to organizational, educational, information, and support systems, through which health care is provided to the population (2) .
Nurses are understood as having a key role in the use of these Health Technologies to achieve the best indicators in BF promotion. This is a dual challenge in facing barriers and in encouraging good BF practices mediated by different scientific knowledge, research methods, and educational processes conducted by the nursing team (3) .
To that end, Health Technologies were classified as soft, soft-hard, and hard (4) . Soft technology is related to interpersonal relations, welcoming, and creation of bonds. Soft-hard technology is related to well-structured knowledge, such as work process or certain fields of knowledge. Finally, hard technology is characterized by concrete materials, such as machines, equipment, and organizational structures (4) .
This study used a soft-hard technology (4) based on John Dewey's pragmatic theory, with the aim of implementing an educational action focused on learner's experience and valuation of practices (5)(6)(7) .
This educational approach is known to be related to The study included pregnant women whose infants were below 60 days of age, according to the following inclusion criteria: having a landline or cell phone and practicing EBF during hospitalization in the roomingin facility. The exclusion criteria were the following: medium-and high-risk mothers and infants, or preterm infants who were not able to be breastfed, as well as postpartum women with communication difficulties, e.g., with a hearing disability or who did not speak Portuguese.
Randomization was performed with numbered, opaque, and sealed envelopes indicating the group to which each woman would be allocated, which were opened by the women themselves or by a companion.
The sample size was estimated by a pilot test (52 subjects in each group), totaling 104 participants.
The data were described as absolute frequencies and percentages for the qualitative variables, and as position and dispersion measures for the quantitative variables.
(3) Illustrative card on correct baby's latch-on: used to illustrate the correct latch-on of the nippleareolar area and adequate opening of baby's mouth to grab most of the areola.
(4) Didactic breast: used to illustrate the internal and external anatomy of the breast, types of nipple, and to teach how to do a circular massage, to extract BM manually, and to use the own mother's colostrum on the nipples after feedings (used exclusively by the researcher in the demonstration).  the milk (fridge/freezer), to defrost it in warm water ("Bain-Marie"), emphasizing that BM should not be boiled or heated in the microwave, and to provide BM in the cup.
The data were collected at two different stages: in the first stage, the procedure was carried out by the main researcher during postpartum at the maternity ward, from 24 to 72 hours after childbirth. In the second stage, after the women's hospital discharge, another professional trained by the researcher performed the blinding, monitoring data from the two groups on the following: type of breastfeeding, difficulties found during breastfeeding, and whether the mother was receiving support at home and, if she was, what and from who was this support, at three different time points (days 10, 30 and 60). This researcher was blind as to which group they belonged, thus preventing possible biases that could arise from a previous contact with the researcher.

Results
The study included 104 postpartum women from a private health institution in the state of São Paulo, Brazil, of whom 52 were allocated to the IG and 52 to the CG.
The women in the IG showed a higher percentage of EBF compared to those in the CG at all time points, with statistical significance (p<0.05). At day 10, there was a higher percentage of EBF than at days 30 or 60 (Table 1). There was statistical significance with regard to maintaining BF for a longer time and a lower percentage of difficulties at the study time points in the group that underwent the intervention with the KEAM in the maternity ward before hospital discharge compared with the CG (Table 2).  (16) .
It is increasingly evident that there is a need for implementing the use of didactic materials and devices capable of assisting and reinforcing the guidelines provided by Nursing and/or health care professionals on the practical management of BF in health institutions, in view of the significant results shown in the present study.
Another key aspect of this study was the fact the educational intervention was based on the pragmatic theory,

Discussion
Although EBF rates have increased in Brazil, it is observed that they are still much lower than the recommended ones in the last three decades (10) . It is known that the BF practice is possible for almost all mothers, but there are several difficulties that contribute to early BF discontinuation (11) .
Among the most prevalent difficulties found in the present study, most were similar in both groups, but there was a statistically significant lower percentage of difficulties in the IG at the analyzed time points compared to the CG, which may have some influence on the maintenance of EBF. Several studies (12)(13)(14)(15) Souza EFC, Pina-Oliveira AA, Shimo AKK.
which provided postpartum women with an opportunity to have a practical experience mediated by the KEAM so that they could manipulate the didactic materials, value illustrative items, and clarify doubts, in order to improve control over their difficulties, desires, and strengths.
These practices showed to be effective in adherence and