Examining the Effect of Breastfeeding Education Given to Mothers Based on Postpartum Awareness Practices on Breast Milk and Cortisol Hormone at the Newborn Circadian Level

January 26, 2024 updated by: Şevin Akgün, Kafkas University
In addition to being an easily accessible and ready-made food for babies in the first years of life, breast milk plays a major role in transmitting information about the time of day to newborn babies and therefore in the formation of the circadian rhythm, thanks to the hormones and various immune elements it contains.The main theme of mindfulness-based programs is mind and body meditation by focusing on the present moment, directing perception to inner experiences and observing these experiences.Regular practice of this type of meditation contributes greatly to increasing happiness and developing positive attitudes such as insight, compassion, awareness and stress management.Cortisol is the main stress hormone in the human body and is therefore a promising benchmark for investigating the effects of mindfulness programs. The purpose of mindfulness-based breastfeeding training to be given to mothers; It is to contribute to a healthy and safe postpartum period and breastfeeding experience for the mother and the newborn by minimizing the negative effects of the postpartum stress level in the mother and the cortisol hormone levels transferred from the mother's milk to the baby on the circadian rhythm.For this purpose, the sample size was planned to be a total of 54 people, 27 people per group, in the experimental design, with G power 3.1 analysis. The research will be conducted on healthy breastfeeding mothers who applied to Erzurum City Hospital and Kars Selim District State Hospital between 15.05.2023 and 15.06.2024.Subjects to be included in the study will be randomly selected among the pregnant women who applied to the clinic according to meeting the inclusion criteria. Breastfeeding: 'The Key to Sustainable Development'. For this reason, it is planned that the determination of the relationship between breast milk and circadian rhythm can be supported by cognitive methods, it will be important in terms of promoting breastfeeding and achieving development goals in a short time, and it is planned to contribute to the literature.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In addition to being an easily accessible and ready-made food for babies in the first years of life, breast milk plays a major role in the transmission of information about the time of day to newborn babies, and therefore in the formation of circadian rhythm, thanks to the hormones and various immune elements it contains . Breast milk is the best way to convey information such as what time of day it is, when to go to sleep and when to wake up . Apart from this, transferring this information to the newborn in a unique way and ensuring its continuity is not as effective and easy as breast milk. The fact that the melatonin hormone, which rises in the breast milk in the evening hours, stimulates the smooth muscles and creates a resting effect, the increase in activity and the awakening state due to the effect of the cortisol hormone in the breast milk in the first hours of the day, ensures the formation of a regular sleep rhythm in the newborn.

Circadian rhythm regulates various physiological and psychological events in living organisms, such as sleep/wake rhythms, body temperature, blood pressure, hormone (melatonin, cortisol, etc.) synthesis and release, in a total period of 24 hours . Circadian rhythm continues to develop in the first three months of life. It is essential for the temporal adaptation process of the newborn and especially for mother-infant coordination . Delay or disruption of this situation negatively affects the neurocognitive development of the baby and causes metabolic problems as well as sleep problems . The most commonly used biological phase markers to examine circadian rhythm; cortisol and melatonin, whose oscillations are quite rhythmic . Cortisol acts through glucocorticoid receptors in almost all mammalian cells, helping to regulate the genetic clock in cells.Cortisol and melatonin levels in breast milk show parallelism with the levels of these hormones in the mother's plasma . The increase in cortisol levels in the first hours of the day and the increase in their rates in breast milk may affect the circadian rhythm negatively, instead of decreasing it in the following hours as a result of the continuity of the stress situation in the mother .

The main theme of mindfulness-based programs is mind and body meditation, which is formed by focusing on the present moment, directing the perception to inner experiences and observing these experiences . Regular practice of this type of meditation greatly contributes to increasing happiness and the development of positive attitudes such as insight, compassion, awareness, and stress management . Cortisol is the main stress hormone in the human body and is therefore a promising benchmark for investigating the effects of Mindfulness-Based Stress Reduction programs . In conjunction with other biological measures, the use of cortisol levels as a physiological marker of stress may be useful to confirm the self-reported benefits attributed to this program .

Among the recent studies on breast milk content on mothers and babies, cognitive-based approaches are preferred because they do not require intervention and have a low probability of posing a risk for the mother and baby, because they are easily accessible, and it is planned to obtain results that will contribute to the literature.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

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 Backup

Study Locations

  • Turkey
      • Kars, Turkey, 36100
        • Kafkas Universty
        • 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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being between the ages of 18-35
  • Having given birth at term (C/S and vaginal)
  • Having a baby who is exclusively breastfed
  • Not participating in any previous cognitive-based program
  • Being at least literate
  • No communication problems

Exclusion Criteria:

  • Mothers with babies who have started supplementary feeding
  • Having any health problems in mother and baby
  • Premature baby
  • Having given birth prematurely
  • Illiteracy

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
After the 3rd month postpartum, mothers who are given classical breastfeeding training by the researcher will then be given a breastfeeding training based on mindfulness therapy methods. After the classical breastfeeding training, a pre-test will be applied and then mindfulness-based training will be started. The effectiveness of the training will also be determined within the group with the post-test to be applied after the training. A sleep diary will be applied to the newborn. After breastfeeding, how many hours of sleep and body temperature will be noted.
Behavioral: AWARENESS-BASED COGNITIVE THERAPY
A 6-week training program based on mindfulness practices will be applied to the experimental group determined by the single-blind method, after the 3rd month after birth. In order to observe the change in the experimental group, breast milk will be taken for pre-test (morning and evening) before training. After 6 weeks of training, a cortisol test will be performed by taking breast milk at 09:00 in the morning and 09:00 in the evening. Taken milk will be stored in the deep freezer for 1 week at -18 degrees. After the samples are prepared for testing under appropriate conditions (centrifuge), biochemical measurements will be made and recorded with the help of the SUNREDBIO brand human cortisol kit (the serial number is not known since we did not purchase the cortisol kit).A sleep diary will be used to measure newborn circadian rhythm.
No Intervention: control group
From mothers whose information was collected during pregnancy, only breast milk will be taken for 1 week without any intervention in the 3rd month after birth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measuring breast milk cortisol value
Time Frame: 4 MONTHS
After 6 weeks of mindfulness-based breastfeeding training, the morning and evening values of the cortisol hormone in breast milk will be measured and compared with the breast milk of the group that was not trained.
4 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
circadian rhythm of the newborn
Time Frame: 4 MONTHS
Post-breastfeeding circadian rhythms (sleep-wakefulness) of babies of trained mothers will be evaluated through a sleep diary.
4 MONTHS

Collaborators and Investigators

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

Sponsor

Kafkas University

Investigators

  • Study Director: Rukiye TÜRK DELİBALTA, Kafkas University Faculty of Health Sciences
  • Principal Investigator: Şevin POLAT, Kafkas University Faculty of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

April 15, 2024

Primary Completion (Estimated)

June 20, 2024

Study Completion (Estimated)

June 20, 2024

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KAU-HEM-SA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For my study titled 'Investigation of the Effects of Breastfeeding Education Given to Mothers Based on Postpartum Mindfulness Practices on the Cortisol Hormone in Breast Milk and Newborn Circadian Levels', a signed document is obtained from the voluntary participants who participate in the study, stating that any information to be used in this study will not be shared with a third party.

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.

Clinical Trials on Health Behavior

Clinical Trials on AWARENESS-BASED COGNITIVE THERAPY

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe