MotivationNCT06344663
Motivational Interviewing Inadequate Milk and Cortisol
An observational study of Motivation, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Motivation
- What is being tested?
- motivational interview
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2024to 25 Dec 2024
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Mothers with the perception of insufficient milk
Who may be able to join
- 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
Who cannot join
- Cannot speak Turkish
- Mothers who did not agree to participate in the research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Eda Sever
Kahramanmaraş, Onikişubat, 46370
eda sever, +90 531 232 10 96, edaseverr@icloud.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Motivation
- Being tested
- motivational interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. Receives: Other: motivational interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. A minimum score of 0 and a maximum score of 50 can be obtained from this scale. A high score indicates that the mother's perception of adequate milk is high
Measured: 1 month
Secondary outcomes (1)
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. No total score is obtained from the scale. As the score obtained from the sub-dimension of the scale increases, the motivation representing that sub-dimension also increases
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start25 Mar 2024
- Primary completion25 Mar 2024
- Study completion25 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MotivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra KARATAŞ OKYAY, Kahramanmaras Sutcu Imam University
- Investigators
- Esra Karataş Okyay, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344663
- Sponsor's protocol ID
- KSIU-SBF-ES-02
- Status last verified
- Jul 2024
- First submitted
- 27 Mar 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviews to Mothers With Insufficient Milk Perception on Breastfeeding Motivation and Cortisol Level
- ClinicalTrials.gov ID
- NCT06344663
- Acronym / sponsor ID
- KSIU-SBF-ES-02
- Conditions
- Motivation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Dec 2024 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| intervention group | – | Other: motivational interviewBefore 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Mothers with the perception of insufficient milk
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Cannot speak Turkish
- Mothers who did not agree to participate in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motivational interviewBefore 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 | Other | intervention group |
Primary outcome
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. A minimum score of 0 and a maximum score of 50 can be obtained from this scale. A high score indicates that the mother's perception of adequate milk is high
1 secondary outcome
Breastfeeding Motivation Scale (EMS)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Karataş Okyay principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motivation, run by Kahramanmaras Sutcu Imam University at 1 site 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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact eda sever (+90 532 232 10 96, edaseverr@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insufficient Milk Perception Scale (ANN) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2024.