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

NCT07177664 | Not Yet Recruiting

• 1 other identifier: Fatma OCAKOGLU
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding; Breastfeeding Education

Keywords

breastfeeding; Breastfeeding Self-Efficacy; Breastfeeding Motivation; Primiparous Women; Nurse Navigation Program; Breastfeeding Counseling

Outcome Measures

Primary Outcomes (5)

• Personal Information Form

  There are 15 questions in this form, prepared by the researchers in line with the literature

  18 months

• Prenatal Breastfeeding Self-Efficacy Scale

  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.

  18 months

• Prenatal Breastfeeding Motivation Assessment Scale

  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.

  18 months

• Breastfeeding Self-Efficacy Scale (Short Form)

  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.

  18 months

• Primiparous Breastfeeding Motivation Scale

  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.

  18 months

Study Arms (2)

Nurse Navigation Program Group

EXPERIMENTAL

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.

Other: Breastfeeding Consultation Provided through the Nurse Navigation Program

Routine Care Group

NO INTERVENTION

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.

Interventions

Breastfeeding Consultation Provided through the Nurse Navigation Program 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.

Nurse Navigation Program Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: being in the 28th to 32nd week of pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Ayşe AYDIN

  Ataturk University

  STUDY DIRECTOR

Central Study Contacts

Ayşe AYDIN

CONTACT

+905434668220; aysea@atauni.edu.tr

Ayşe AYDIN

CONTACT

+905434668220; aysea@ataun.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Statistics expert, Participant
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 17, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)