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BreastfeedingNCT06623292

The Effect of Motivational Interviewing-Based Breastfeeding Education on Breastfeeding Motivation and Self-Efficacy

A study testing Motivational interviewing-based breastfeeding education in people with Breastfeeding and Motivation, run by Istanbul Medeniyet University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breastfeeding, Motivation, Self Efficacy
What is being tested?
Motivational interviewing-based breastfeeding education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
2 sitesTurkey (Türkiye)
Study dates
15 Oct 2024to 15 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Istanbul Medeniyet University

    Istanbul, Kadıköy, 34720

  • Istanbul Medeniyet University

    Kadıköy, Istanbul, 34862

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Motivational Interviewing-Based Breastfeeding Education Given to Mothers With Infants in the Neonatal Intensive Care Unit on Breastfeeding Motivation and Breastfeeding Self-Efficacy: A Randomized Controlled Trial

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.

Read the detailed description

Midwives and nurses working in the Neonatal Intensive Care Unit (NICU) are in a unique position to support the breastfeeding process and breastfeeding self-efficacy of mothers whose babies are hospitalized in the NICU. Health care professionals can use a variety of methods to support mothers' breastfeeding self-efficacy and encourage breastfeeding. Individualized interventions, breastfeeding education, and motivational interviewing are some of them. Motivational interviewing is basically a client-centered psychosocial intervention that helps individuals discover and resolve ambivalent feelings about health behaviors, learn new skills, and improve existing skills. In the breastfeeding process, the mother's motivation and positive intention are shown to be important indicators of breastfeeding continuation.

Health education about breastfeeding provided by neonatal intensive care nurses to mothers whose babies are hospitalized in the NICU for various reasons is one of the important initiatives of nurses. The contribution of health education planned with effective educational techniques for both mother and baby is undoubtedly very valuable. However, one of the important variables that should not be forgotten in the success of this education provided by the nurse is motivation, which also affects the self-efficacy of mothers regarding breastfeeding. In order to ensure the readiness of mothers to be educated about the breastfeeding process and breastfeeding of the infant hospitalized in the NICU, it would be appropriate to support the health education planned for mothers whose infants are hospitalized in the NICU with a motivational interviewing intervention. Based on this information, the planned research will examine the effect of motivational interviewing-based breastfeeding education provided to mothers whose infants are hospitalized in the NICU on mothers' breastfeeding motivation and breastfeeding self-efficacy.

Being tested
Motivational interviewing-based breastfeeding education
Keywords
Breastfeeding motivation, Breastfeeding self-efficacy, Motivational interview
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational interviewing-based breastfeeding educationOther

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

Study groups in NCT06623292
Study groupRoleWhat they receive
Control groupNo interventionMothers 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 groupExperimentalMothers 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.
Receives: Other: Motivational interviewing-based breastfeeding education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2024
  2. Study start15 Oct 2024
  3. Primary completion15 Feb 2025
  4. Study completion15 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06623292
Sponsor's protocol ID
26.04.2024-04/05
Status last verified
Apr 2025
First submitted
30 Sep 2024
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 31181186

  • 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.

    PubMed 31782535

  • Unal Aktas E, Aytekin Ozdemir A, Yoruk I. The effect of motivational interviewing-supported breastfeeding education on motivation and self-efficacy in mothers whose full-term infants are hospitalized in the neonatal intensive care unit: A randomized controlled trial. Midwifery. 2026 Jul;158:104810. doi: 10.1016/j.midw.2026.104810. Epub 2026 Apr 5.

    PubMed 41950831

Questions about this trial

What is this clinical trial studying?

A study testing Motivational interviewing-based breastfeeding education in people with Breastfeeding and Motivation, run by Istanbul Medeniyet University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breastfeeding Self-Efficacy Scale-Short Form (time frame: On the first day of the baby's admission to the NICU (pretest), at discharge, 15 days after discharge, one month after discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06623292, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

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