NCT06623292

Brief Summary

This study is being conducted to examine the effect of a motivational interviewing-based breastfeeding education intervention provided to mothers whose infants are hospitalized in the neonatal intensive care unit on the mothers' breastfeeding motivation and breastfeeding self-efficacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

September 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

September 30, 2024

Last Update Submit

April 24, 2025

Conditions

Keywords

Breastfeeding motivationBreastfeeding self-efficacyMotivational interview

Outcome Measures

Primary Outcomes (2)

  • Breastfeeding Self-Efficacy Scale-Short Form

    The scale is 5-point Likert type. The items of the scale are scored as 1= "I am never sure" and 5 = "I am always sure". All items of the scale are positive. The lowest score is 14 and the highest score is 70. An increase in scale scores indicates an increase in breastfeeding self-efficacy.

    On the first day of the baby's admission to the NICU (pretest), at discharge, 15 days after discharge, one month after discharge

  • Breastfeeding Motivation Scale

    The scale has a 4-point Likert-type scale scoring system. Each item is scored between 1="Strongly Disagree" and 4="Strongly Agree". The score of the sub-dimensions is calculated by averaging the scale sub-dimension scores \[136\]. As the score obtained from the sub-dimension of the scale increases, the motivation representing the sub-dimension also increases.

    On the first day of the baby's admission to the NICU (pretest), at discharge, 15 days after discharge, one month after discharge

Study Arms (2)

Control group

NO INTERVENTION

Mothers in this group will not receive any treatment in the study. Mothers will fill out the "Breastfeeding Self-Efficacy Scale" and "Breastfeeding Motivation Scale" four times: on the first day of the baby's NICU admission, when their baby is discharged, 15 days after discharge and one month later discharge. In addition, a follow-up form will be completed.

Intervention group

EXPERIMENTAL

Mothers in this group will receive motivational interview-based breastfeeding education. Mothers will fill out the "Breastfeeding Self-Efficacy Scale" and the "Breastfeeding Motivation Scale" four times: on the first day of the baby's NICU admission, when their baby is discharged, 15 days after discharge and one month later discharge. In addition, a follow-up form will be completed.

Other: Motivational interviewing-based breastfeeding education

Interventions

This program includes breastfeeding motivational interviewing consisting of a total of 4 sessions and breastfeeding education consisting of one session.

Intervention group

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A baby born at 38-42 weeks gestational week admitted to the NICU,
  • Who started breastfeeding her baby in the NICU,
  • Literate in Turkish,
  • Open to communication and cooperation,
  • Volunteered to participate in the study,
  • Willing to breastfeed your baby,
  • Have a smart phone and internet connection,
  • Mothers who scored 60 or less on the Breastfeeding Self-Efficacy Scale in the pretest

You may not qualify if:

  • Any chronic illness and pregnancy complications,
  • A condition that prevents breastfeeding,
  • The mother has a diagnosed psychiatric illness,
  • Mothers with a history of substance abuse.
  • The presence of an obstacle to oral feeding and sucking in the infant,
  • The baby has genetic, congenital anomalies, neurological, cardiac and metabolic diseases,
  • The baby has undergone surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul Medeniyet University

Kadıköy, Istanbul, 34862, Turkey (Türkiye)

Location

Istanbul Medeniyet University

Istanbul, Kadıköy, 34720, Turkey (Türkiye)

Location

Related Publications (2)

  • Addicks SH, McNeil DW. Randomized Controlled Trial of Motivational Interviewing to Support Breastfeeding Among Appalachian Women. J Obstet Gynecol Neonatal Nurs. 2019 Jul;48(4):418-432. doi: 10.1016/j.jogn.2019.05.003. Epub 2019 Jun 7.

    PMID: 31181186BACKGROUND
  • Franco-Antonio C, Calderon-Garcia JF, Santano-Mogena E, Rico-Martin S, Cordovilla-Guardia S. Effectiveness of a brief motivational intervention to increase the breastfeeding duration in the first 6 months postpartum: Randomized controlled trial. J Adv Nurs. 2020 Mar;76(3):888-902. doi: 10.1111/jan.14274. Epub 2019 Dec 18.

    PMID: 31782535BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Aynur Aytekin Özdemir, PhD

    Istanbul Medeniyet University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be assigned to experimental and control groups using block randomization method. Randomization of mothers will be done according to maternal age and number of births. Maternal age (19-25 years and 26 years and older) and number of births (primiparous and multiparous) variables will be used for block randomization. In order to reach the sample size calculated in the study, strata will be repeated six times (2X2X6) and 24 mothers will be included in each group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 30, 2024

First Posted

October 2, 2024

Study Start

October 15, 2024

Primary Completion

February 15, 2025

Study Completion

February 15, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.

Shared Documents
STUDY PROTOCOL
Time Frame
July through December of 2025
Access Criteria
Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.

Locations