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

NCT06240676 | Unknown

• 1 other identifier: KAU-HEM-SA-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mother Fetus Relations; Health Behavior

Keywords

Breast Milk, Cortisol Hormone, Conscious Awareness, Stress

Outcome Measures

Primary Outcomes (1)

• measuring breast milk cortisol value

  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 Outcomes (1)

• circadian rhythm of the newborn

  4 MONTHS

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

AWARENESS-BASED COGNITIVE THERAPY BEHAVIORAL

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.

experimental group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: mothers and expectant mothers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kafkas University: lead

Study Sites (1)

Kafkas Universty

Kars, 36100, Turkey (Türkiye)

Location

Related Publications (7)

• Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28.

  PMID: 27687118 RESULT

• Zollars I, Poirier TI, Pailden J. Effects of mindfulness meditation on mindfulness, mental well-being, and perceived stress. Curr Pharm Teach Learn. 2019 Oct;11(10):1022-1028. doi: 10.1016/j.cptl.2019.06.005. Epub 2019 Aug 7.

  PMID: 31685171 RESULT

• Parsons CE, Crane C, Parsons LJ, Fjorback LO, Kuyken W. Home practice in Mindfulness-Based Cognitive Therapy and Mindfulness-Based Stress Reduction: A systematic review and meta-analysis of participants' mindfulness practice and its association with outcomes. Behav Res Ther. 2017 Aug;95:29-41. doi: 10.1016/j.brat.2017.05.004. Epub 2017 May 10.

  PMID: 28527330 RESULT

• Ziomkiewicz A, Babiszewska M, Apanasewicz A, Piosek M, Wychowaniec P, Cierniak A, Barbarska O, Szoltysik M, Danel D, Wichary S. Psychosocial stress and cortisol stress reactivity predict breast milk composition. Sci Rep. 2021 Jun 2;11(1):11576. doi: 10.1038/s41598-021-90980-3.

  PMID: 34078999 RESULT

• Italianer MF, Naninck EFG, Roelants JA, van der Horst GTJ, Reiss IKM, Goudoever JBV, Joosten KFM, Chaves I, Vermeulen MJ. Circadian Variation in Human Milk Composition, a Systematic Review. Nutrients. 2020 Aug 4;12(8):2328. doi: 10.3390/nu12082328.

  PMID: 32759654 RESULT

• van der Voorn B, de Waard M, van Goudoever JB, Rotteveel J, Heijboer AC, Finken MJ. Breast-Milk Cortisol and Cortisone Concentrations Follow the Diurnal Rhythm of Maternal Hypothalamus-Pituitary-Adrenal Axis Activity. J Nutr. 2016 Nov;146(11):2174-2179. doi: 10.3945/jn.116.236349. Epub 2016 Sep 14.

  PMID: 27629575 RESULT

• Nagel EM, Howland MA, Pando C, Stang J, Mason SM, Fields DA, Demerath EW. Maternal Psychological Distress and Lactation and Breastfeeding Outcomes: a Narrative Review. Clin Ther. 2022 Feb;44(2):215-227. doi: 10.1016/j.clinthera.2021.11.007. Epub 2021 Dec 20.

  PMID: 34937662 RESULT

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Rukiye TÜRK DELİBALTA

  Kafkas University Faculty Of Health Sciences

  STUDY DIRECTOR

• Şevin POLAT

  Kafkas University Faculty Of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SEVİN POLAT

CONTACT

05438082242; sevin.akgun@erzurum.edu.tr

Rukiye TÜRK DELİBALTA

CONTACT

05313740528; rahsantur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be given the option of two envelopes, one of which is experiment and the other is control. Participants will be asked to choose one of the two envelopes when applying to the obstetrics clinic of the hospital.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: THE FEMALE MILK OF TWO GROUPS WILL BE COMPARED WITH EDUCATIONAL AND NON-EDUCATIONAL

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 5, 2024
• Study Start: April 15, 2024
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)