- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06623292
The Effect of Motivational Interviewing-Based Breastfeeding Education on Breastfeeding Motivation and Self-Efficacy
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kadıköy
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Istanbul, Kadıköy, Turkey, 34720
- Istanbul Medeniyet University
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İ̇stanbul
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Kadıköy, İ̇stanbul, Turkey, 34862
- Istanbul Medeniyet University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group
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.
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Experimental: Intervention group
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.
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This program includes breastfeeding motivational interviewing consisting of a total of 4 sessions and breastfeeding education consisting of one session.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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On the first day of the baby's admission to the NICU (pretest), at discharge, 15 days after discharge, one month after discharge
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Breastfeeding Motivation Scale
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
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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.
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On the first day of the baby's admission to the NICU (pretest), at discharge, 15 days after discharge, one month after discharge
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Aynur Aytekin Özdemir, PhD, Istanbul Medeniyet University
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 26.04.2024-04/05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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