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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06344663
Other study ID # KSIU-SBF-ES-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 25, 2024
Est. completion date December 25, 2024

Study information

Verified date March 2024
Source Kahramanmaras Sutcu Imam University
Contact eda sever
Phone +90 532 232 10 96
Email edaseverr@icloud.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Motivational interviewing is a technique used in many fields. No study has been found in national and international databases investigating the effect of motivational interviewing on the perception of insufficient milk, breastfeeding motivation and cortisol level. The study aimed to evaluate the effect of motivational interviews on the perception of insufficient milk, breastfeeding motivation and cortisol level.


Description:

Motivational interviewing; It is an evidence-based and client-centered approach that finds and eliminates the person's complex emotions, motivates, and increases the person's self-efficacy and motivation in the decision-making process. Breast milk is the only physiological baby food that contains the nutrients necessary for babies' absorption in appropriate quantity and quality. It is very important for the mother and baby's health that the mother starts breastfeeding her baby as early as possible and that the baby is fed only breast milk for the first six months. The perception of insufficient milk is defined as the mother thinking that she cannot produce milk or believing that there is too little milk in her breasts. The main reasons are; The mother's stay in the hospital longer than normal during the postpartum period, the mother's separation from her baby, and therefore the late establishment of the emotional bond between the mother and the baby may trigger the perception of insufficient milk. Cortisol is a glucocorticoid steroid hormone that is released in the human body during stress and whose release is regulated through the hypothalamic-pituitary adrenal (HPA) system. Stress and fear of birth cause insufficient milk secretion. Stress and fear in the mother can prevent early skin-to-skin contact between the mother and the baby by affecting the oxytocin hormone.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date December 25, 2024
Est. primary completion date March 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Those aged 18 and over - Those who feed their babies only with breast milk - Do you believe that you produce enough milk to feed your baby?" in the Insufficient Milk Perception Scale. Those who answered "No" to the question - Having given birth at 37>gestational weeks - Having a baby weighing at least 2500 grams - Giving birth vaginally - Primiparous Exclusion Criteria: - Cannot speak Turkish - Mothers who did not agree to participate in the research

Study Design


Related Conditions & MeSH terms


Intervention

Other:
motivational interview
Before starting the interview, mothers will be informed about the interview intervals, duration, how many times it will be held, and that, unlike other interviews, the topic will be determined and the mother's opinions on this subject will be obtained. Each meeting will last approximately 15-30 minutes

Locations

Country Name City State
Turkey Eda Sever Kahramanmaras Onikisubat

Sponsors (1)

Lead Sponsor Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Visual Analog Scale (VAS) Satisfaction Level Rating with Motivational Interviewing Application is a scale developed by Hayes and Patterson in 1921, used to express some values that cannot be measured with numbers. 1 month
Primary Insufficient Milk Perception Scale (ANN) The Insufficient Milk Perception Scale is a scale developed by McCarterSpaulding (2001) to measure mothers' beliefs about whether they produce sufficient milk. It consists of 6 questions 1 month
Secondary Breastfeeding Motivation Scale (EMS) Based on the self-determination theory of the "Breastfeeding Motivation Scale" (EMS), Peleg et al. It was developed by in 2015. After the scale was applied to the sample group, factor analysis was performed and it was determined that it had 5 factors. These factors; It consists of integrated, identified, introjected, external regulation and internal motivation. 1 month
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