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临床试验/NCT06701227
NCT06701227已完成不适用

In Situ Simulation in Prenatal Breastfeeding Education

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年10月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
Female
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: In Situ Simulation (Other)

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.

结局指标

主要结局

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

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Taison Regis Penariol Natarelli

PhD student

University of Sao Paulo

研究点 (1)

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