Effect of a Nurse Navigation Program on Breastfeeding Self-Efficacy and Motivation in Primiparous Women

NCT ID: NCT07177664

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-10-01

Brief Summary

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.

Detailed Description

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.

Second Meeting: After 36 weeks, breastfeeding training using a newborn mannequin and educational booklet; post-training reassessment.

Third Meeting: Within seven days postpartum; reinforcement of breastfeeding education and administration of postnatal scales.

Fourth Meeting: End of postpartum 6th week; continued training and scale reassessment.

Fifth Meeting: Fourth postpartum month; conducted online or by phone, infant feeding status assessed.

Sixth Meeting: Sixth postpartum month; online or phone session to evaluate exclusive breastfeeding continuation versus complementary feeding initiation.

Control Group Participants will attend six assessment points corresponding to the intervention group but will receive routine care only. Assessments will be conducted face-to-face, via home visits, or online depending on participant preference.

Data Analysis Data will be coded and analyzed using SPSS version 25. Descriptive statistics will include frequency, percentage, mean, and standard deviation. Normality will be evaluated using skewness and kurtosis coefficients. Appropriate statistical tests will be applied based on data type, including Chi-square, independent samples t-test, Mann-Whitney U, ANOVA, Kruskal-Wallis, paired t-test, Wilcoxon, or Friedman tests. Significance level is p < 0.05. Internal consistency of scales will be assessed with Cronbach's alpha, and effect sizes calculated using Cohen's d or eta-squared for relevant comparisons. All ethical principles will be strictly observed throughout the study.

Conditions

Breastfeeding; Breastfeeding Education

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Breastfeeding Consultation Provided through the Nurse Navigation Program

Intervention Type: OTHER

The navigator nurse will meet with the pregnant woman/mother starting at 28-32 weeks of gestation and continuing until the sixth month postpartum. During these meetings, planned breastfeeding education will be provided, women's questions about breastfeeding will be answered, and counseling will be provided to address any concerns.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Breastfeeding Consultation Provided through the Nurse Navigation Program

The navigator nurse will meet with the pregnant woman/mother starting at 28-32 weeks of gestation and continuing until the sixth month postpartum. During these meetings, planned breastfeeding education will be provided, women's questions about breastfeeding will be answered, and counseling will be provided to address any concerns.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Ayse Aydin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayşe AYDIN

Role: STUDY_DIRECTOR

Ataturk University

Locations

Ataturk University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Ayşe AYDIN

Role: CONTACT

aysea@atauni.edu.tr

+905434668220

Ayşe AYDIN

Role: CONTACT

aysea@ataun.edu.tr

+905434668220

Other Identifiers

Fatma OCAKOGLU

Identifier Type: -

Identifier Source: org_study_id