Motivational Interviewing Inadequate Milk and Cortisol

July 7, 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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Onikişubat
      • Kahramanmaraş, Onikişubat, Turkey, 46370
        • Recruiting
        • Eda Sever
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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. 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 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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. 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
1 month

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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. In the satisfaction rating scale, which was created by taking the Visual Analog Scale as an example, the mother's satisfaction level will be marked on this line by writing "not at all satisfied" on one end and "very satisfied" on the other end.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kahramanmaras Sutcu Imam University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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