NCT06313034

Brief Summary

This study aimed to determine the effect of breastfeeding education given to mothers who gave birth vaginally using motivational interviewing technique on breastfeeding motivation, self-efficacy and attachment. The study will be conducted as a single-blind, randomized controlled trial.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

March 5, 2024

Last Update Submit

March 9, 2024

Conditions

Keywords

AttachmentBreastfeeding MotivationBreastfeeding Self-EfficacyMotherMotivational Interview

Outcome Measures

Primary Outcomes (4)

  • Mother Introductory Information Form

    It was prepared in line with the literature. The form consists of a total of 27 questions, including information about socio-demographic information, obstetric, newborn characteristics.breastfeeding characteristics

    one day

  • Primipara Breastfeeding Motivation Scale

    It was developed to determine the factors affecting breastfeeding motivation in primiparous women. The scale is a 7-point Likert type, consisting of a total of 29 items and 4 sub-dimensions. These sub-dimensions; the value placed on breastfeeding, self-efficacy, perceived midwife support and expectation of success. There is no cut-off value and total score in the evaluation of the scale. As the score obtained from each sub-dimension increases, the breastfeeding motivation level of that sub-dimension increases.

    Three months

  • Breastfeeding Self-Efficacy Scale Short Form

    The scale is a 5-point Likert type and consists of 14 questions in total. The lowest score that can be obtained from the scale is 14 and the highest score is 70. High scores are interpreted as high breastfeeding self-efficacy.

    Three months

  • Mother-Baby Attachment Scale

    The scale has a total of 8 items and is a 4-point Likert type. Responses are scored between 0-3. In the evaluation, items with positive emotion expressions (1, 4, 6.) were scored as 0, 1, 2, 3, while items with negative emotion expressions (2, 3, 5, 7, 8.) were scored as 3, 2, 1,0. It is scored as. The lowest score that can be obtained from the scale is 0 and the highest score is 24. As the score obtained from the scale increases, the level of mother-infant attachment decreases

    Three months

Study Arms (2)

experimental group

EXPERIMENTAL

Breastfeeding education will be given to mothers in the experimental group in 4 individual and face-to-face sessions based on motivational interviewing technique. The first session of breastfeeding training based on motivational interviewing technique will be held in the delivery room where the mother is hospitalized before being discharged from the hospital. Other sessions will be held according to the monitoring frequency recommended in the Postnatal Care Management Guide of the Ministry of Health of the Republic of Turkey (2018). These will be done at the health institution where the mother receives service. Second session; Between the 2th and 5th postpartum day Third session; Between the 13th and 17th postpartum day Fourth session; Between the 30th and 42th postpartum day The duration of each motivational interview is planned to be between 30-40 minutes on average.

Behavioral: Breastfeeding education based on motivational interviewing technique

control group

NO INTERVENTION

Before discharge, mothers in the control group will be given routine breastfeeding training by the midwife working in the delivery room in accordance with the mother/baby friendly hospital protocol.

Interventions

Breastfeeding education based on motivational interviewing technique; Breast milk properties, benefits to mother and baby, breastfeeding positions, the relationship between breastfeeding and attachment, signs of hunger in the newborn, Breastfeeding frequency, duration and termination, Breast milk expressing methods, Expressions showing that the newborn has enough milk, Breast milk storage will cover the topics. These topics will be given based on motivational interviewing technique. According to the motivational interviewing technique, the mother's "intention, importance and confidence-sufficiency" regarding breastfeeding will be determined and firstly, an agenda will be created on "issues related to breastfeeding with the mother". Each session will be conducted by following the "open-ended questioning, verification, reflective listening and summarizing" approaches of the motivational interviewing technique.

experimental group

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Maternal criteria;
  • Agreeing to participate in the research
  • Being 20 years or older
  • Having had a vaginal birth
  • being primiparous
  • Being at least a primary school graduate
  • Ability to speak Turkish
  • Not having any condition that would prevent communication
  • No medical breast problem
  • Criteria for the baby;
  • Being born at term (38-41 gestational weeks)
  • There is no congenital anomaly such as cleft palate or lip of the newborn that may prevent sucking.
  • Birth weight over 2500 grams

You may not qualify if:

  • Maternal criteria;
  • Having a chronic disease that prevents breastfeeding
  • Having major breast problems that will prevent breastfeeding
  • The mother has a diagnosed psychiatric disease
  • Having 2 or more live newborns in this birth
  • Criteria for the baby;
  • Premature birth (37th gestational week and before)
  • Having a congenital disease
  • Being in the risk group/being diagnosed with a disease in the newborn screening program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gümüşhane University

Gümüşhane, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • ÖZGE PALANCI AY

    Gümüşhane Universıty

    PRINCIPAL INVESTIGATOR
  • SONGÜL AKTAŞ

    Karadeniz Technical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ÖZGE PALANCI AY

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
While it is known by the researcher whether the mothers are in the experimental or control group, it is not known by the mother.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The sample of the research will consist of mothers who gave primary vaginal birth (40 experimental group and 40 control group)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 15, 2024

Study Start

May 1, 2023

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations