The Effect of a Nurse Navigation Program on Breastfeeding Self-Efficacy Perception and Breastfeeding Motivation in Primiparous Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Personal Information Form
研究概览
简要总结
Objective: To evaluate the effects of a nurse navigation program on breastfeeding self-efficacy and breastfeeding motivation in primiparous women. The research will be conducted as a randomized controlled trial with a pretest-posttest control group.
详细描述
The study aims to evaluate the effect of a Nurse Navigation Program on breastfeeding self-efficacy perception and breastfeeding motivation in primiparous women. The study population will consist of women aged 18-35 years between the 28th and 32nd weeks of gestation who apply to Yıldızkent, Yenişehir, Adnan Menderes, and Şerif Efendi Family Health Centers between October 2025 and October 2026. Sample size was determined through a priori power analysis using G*Power 3.1.9.4, and repeated measures analysis of variance (ANOVA) was planned. To achieve a power of over 80% at a significance level of 0.05 with a medium effect size, 48 participants were required. Considering potential withdrawal or exclusion, the sample was increased to 100 participants (50 intervention, 50 control). Participants meeting inclusion criteria will be selected by simple random sampling, with allocation to intervention or control groups through randomization. The researcher cannot be blinded, but the statistician will be blinded to group assignment. Data from groups coded as A and B will be analyzed by an independent statistician. The study will follow CONSORT 2010 Flow Diagram guidelines.
Data Collection Data will be collected using the Personal Information Form, Prenatal Breastfeeding Self-Efficacy Scale, Prenatal Breastfeeding Motivation Assessment Checklist, Breastfeeding Self-Efficacy Scale-Short Form, and Primiparous Breastfeeding Motivation Scale. The intervention group will receive structured breastfeeding counseling via the Nurse Navigation Program from the prenatal period until six months postpartum. Scheduled follow-up visits will occur over approximately eight months. The control group will receive routine care only, with data collected in parallel.
Intervention Group
Participants will attend six sessions:
First Meeting: Study orientation, informed consent, baseline assessments including personal information, prenatal self-efficacy, and motivation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Statistics expert, Participant
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being primiparous,
- •Not having a health problem that would prevent breastfeeding,
- •Being in the 28th-32nd weeks of pregnancy,
- •Being between the ages of 18 and 35,
- •Having at least a primary school degree,
- •Residing in the city center of Erzurum,
- •Not having a hearing or vision problem,
- •Not having been diagnosed with a psychiatric illness,
- •Being fluent in Turkish,
- •Being able to use a telephone,
- •Women who voluntarily agreed to participate in the study will be included in the sample.
排除标准
- •Having given birth before 37 weeks of gestation,
- •Having a health problem requiring the newborn to be in intensive care,
- •Having a health problem/birth complication that would prevent breastfeeding during the study period,
- •Withdrawal from the study at the woman's request,
研究组 & 干预措施
Routine Care Group
Data will be collected from the control group at parallel times with the intervention group, which will only receive routine applications without any intervention. In the data collection process, the Personal Information Form, the Prenatal Breastfeeding Self-Efficacy Scale, and the Prenatal Breastfeeding Motivation Table and Breastfeeding Motivation scales developed by the researcher to assess Breastfeeding Motivation will be used in parallel with the intervention group.
Nurse Navigation Program Group
The study includes women meeting inclusion criteria and consenting to participate. For the randomized intervention group, the process will last about eight months.The first meeting at 28-32 weeks gestation will be at the Family Health Center. The Personal Information Form, Prenatal Breastfeeding Self-Efficacy Scale, and researcher-developed Prenatal Breastfeeding Motivation Checklist will be applied as pretests.Each participant will attend at least four face-to-face sessions-two prenatal and two postpartum-with two additional sessions conducted in person or online per preference.Session 1: 28-32 weeks.
S2: After 36 weeks, breastfeeding education and brochure; scales repeated.S3: Within one week postpartum; education reinforced; scales applied.S4: 6th postpartum week; training repeated; scales applied S5: 4th postpartum month, face-to-face or online; breastfeeding continuation assessed.S6: 6th postpartum month, face-to-face or online; exclusive breing or complementary feeding assessed.
干预措施: Breastfeeding Consultation Provided through the Nurse Navigation Program (Other)
结局指标
主要结局
Personal Information Form
时间窗: 18 months
There are 15 questions in this form, prepared by the researchers in line with the literature
Prenatal Breastfeeding Self-Efficacy Scale
时间窗: 18 months
Prenatal Breastfeeding Self-Efficacy Scale was originally developed to assess pregnant women's perceptions of breastfeeding self-efficacy during the prenatal period. Its validity and reliability for the Turkish context were confirmed in a subsequent adaptation study, which reported a Cronbach's alpha coefficient of 0.86. The scale comprises 20 items, each rated on a 5-point Likert scale ranging from 1 ('Not at all sure') to 5 ('Completely sure'). It is unidimensional, meaning it has no sub-dimensions, and is evaluated based on the total score. The possible total scores range from 20 to 100, with higher scores indicating a greater sense of breastfeeding self-efficacy.
Prenatal Breastfeeding Motivation Assessment Scale
时间窗: 18 months
Prenatal Breastfeeding Motivation Assessment Scale was developed by the researcher in the form of a Visual Analog Scale (VAS). Participants are asked to rate their response to the question, "How confident am I that I will be able to breastfeed my baby successfully after birth?" on a scale from 0 = Not confident at all to 10 = Completely confident.
Breastfeeding Self-Efficacy Scale (Short Form)
时间窗: 18 months
The original Breastfeeding Self-Efficacy Scale consists of 33 items. The scale was simplified in 2003, resulting in a 14-item short form, referred to as the 'Breastfeeding Self-Efficacy Scale - Short Form.' The scale was culturally adapted into Turkish, and its psychometric properties were evaluated. To determine validity during the antenatal and postnatal periods, construct validity, linguistic validity, and predictive validity analyses were conducted. This is a 5-point Likert-type scale, with responses ranging from '1 = Not at all confident' to '5 = Always confident.' All items are positively worded. Total scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy. Cronbach's alpha coefficient for the scale is 0.93.
Primiparous Breastfeeding Motivation Scale
时间窗: 18 months
The scale is a four-point Likert-type instrument, originally comprising 24 items across five subdimensions. During its original development, Cronbach's alpha coefficients for the subdimensions ranged from 0.56 to 0.89. The scale was subsequently adapted into Turkish, resulting in a 23-item version with five subdimensions, validated for use with primiparous women. Items are rated on a four-point Likert-type scale from '1 = Strongly disagree' to '4 = Strongly agree.' Scores for each subdimension are interpreted separately, with higher scores indicating higher motivation levels, rather than computing a total score. For the Turkish-adapted version, the overall internal consistency, measured by Cronbach's alpha, was 0.88.
次要结局
未报告次要终点
研究者
Ayse Aydin
Principal Investigator
Ataturk University