- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06344663
Motivational Interviewing Inadequate Milk and Cortisol
March 27, 2024 updated by: Esra KARATAŞ OKYAY, Kahramanmaras Sutcu Imam University
The Effect of Motivational Interviews to Mothers With Insufficient Milk Perception on Breastfeeding Motivation and Cortisol Level
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.
Study Overview
Detailed 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.
Study Type
Observational
Enrollment (Estimated)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: eda sever
- Phone Number: +90 532 232 10 96
- Email: edaseverr@icloud.com
Study Locations
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Onikişubat
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Kahramanmaraş, Onikişubat, Turkey, 46370
- Recruiting
- Eda Sever
-
Contact:
- eda sever
- Phone Number: +90 531 232 10 96
- Email: edaseverr@icloud.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Mothers with the perception of insufficient milk
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
control group
Mothers who will be included in the control group will be interviewed twice in total.
Pretest data will be obtained by applying the "Personal Information Form", "Insufficient Milk Perception Scale" and "Breastfeeding Motivation Scale" during the first interview.
A sample of the mothers' saliva will be taken to measure cortisol values.
Four weeks after the pre-test data are obtained, post-test data will be obtained by applying the "Insufficient Milk Perception Scale" and "Breastfeeding Motivation Scale".
Finally, a saliva sample will be taken to check the cortisol value again.
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|
intervention group
Before starting the motivational interviews, pre-test data will be obtained by applying the "Personal Information Form", "Insufficient Milk Perception Scale" and "Breastfeeding Motivation Scale" to the mothers in the intervention group.
Afterwards, a sample of the mothers' saliva will be taken to measure their cortisol levels.
A total of 4 sessions of motivational interviews will be held for infertile women, 1 session per week for four weeks.
At the end of four weeks, post-test data will be obtained by applying the "Insufficient Milk Perception Scale" and "Breastfeeding Motivation Scale".
A sample of the mothers' saliva will be taken to measure cortisol levels again.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insufficient Milk Perception Scale (ANN)
Time Frame: 1 month
|
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
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1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breastfeeding Motivation Scale (EMS)
Time Frame: 1 month
|
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.
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1 month
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: 1 month
|
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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Esra Karataş Okyay, Kahramanmaras Sutcu Imam University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 25, 2024
Primary Completion (Actual)
March 25, 2024
Study Completion (Estimated)
December 25, 2024
Study Registration Dates
First Submitted
March 27, 2024
First Submitted That Met QC Criteria
March 27, 2024
First Posted (Actual)
April 3, 2024
Study Record Updates
Last Update Posted (Actual)
April 3, 2024
Last Update Submitted That Met QC Criteria
March 27, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- KSIU-SBF-ES-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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