Mother Fetus RelationsNCT06240676
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
A study testing AWARENESS-BASED COGNITIVE THERAPY in people with Mother Fetus Relations and Health Behavior, run by Kafkas University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mother Fetus Relations, Health Behavior
- What is being tested?
- AWARENESS-BASED COGNITIVE THERAPY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 20 Jun 2024
- Phase
- Interventional
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Mothers with babies who have started supplementary feeding
- Having any health problems in mother and baby
- Premature baby
- Having given birth prematurely
- Illiteracy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kafkas Universty
Kars, 36100
Rukiye TÜRK DELİBALTA, 05313740528, rahsantur@gmail.com
About this study
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.
Read the 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.
- Conditions
- Mother Fetus Relations, Health Behavior
- Being tested
- AWARENESS-BASED COGNITIVE THERAPY
- Keywords
- Breast Milk, Cortisol Hormone, Conscious Awareness, Stress
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWARENESS-BASED COGNITIVE THERAPYBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 MONTHS
Secondary outcomes (1)
circadian rhythm of the newborn
Post-breastfeeding circadian rhythms (sleep-wakefulness) of babies of trained mothers will be evaluated through a sleep diary.
Measured: 4 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 Apr 2024 (estimated)
- Primary completion20 Jun 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mother Fetus RelationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- THE FEMALE MILK OF TWO GROUPS WILL BE COMPARED WITH EDUCATIONAL AND NON-EDUCATIONAL
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şevin Akgün, Kafkas University
- Investigators
- Rukiye TÜRK DELİBALTA, Study director, Kafkas University Faculty Of Health SciencesŞevin POLAT, Principal investigator, Kafkas University Faculty Of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240676
- Sponsor's protocol ID
- KAU-HEM-SA-01
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28.
PubMed 27687118Zollars 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.
PubMed 31685171Parsons 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.
PubMed 28527330Ziomkiewicz 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.
PubMed 34078999Italianer 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.
PubMed 32759654van 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.
PubMed 27629575Nagel 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.
PubMed 34937662
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06240676
- Acronym / sponsor ID
- KAU-HEM-SA-01
- Conditions
- Mother Fetus Relations, Health Behavior
- Keywords
- Breast Milk, Cortisol Hormone, Conscious Awareness, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 5 Feb 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- THE FEMALE MILK OF TWO GROUPS WILL BE COMPARED WITH EDUCATIONAL AND NON-EDUCATIONAL
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: AWARENESS-BASED COGNITIVE THERAPYAfter 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. |
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Mothers with babies who have started supplementary feeding
- Having any health problems in mother and baby
- Premature baby
- Having given birth prematurely
- Illiteracy
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 |
|---|---|---|
| AWARENESS-BASED COGNITIVE THERAPYA 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. | Behavioural | experimental group |
Primary outcome
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.
1 secondary outcome
circadian rhythm of the newborn
Time frame: 4 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Results publication: PubMed 27687118Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28.
- Results publication: PubMed 31685171Zollars 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.
- Results publication: PubMed 28527330Parsons 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.
- Results publication: PubMed 34078999Ziomkiewicz 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.
- Results publication: PubMed 32759654Italianer 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.
- Results publication: PubMed 27629575van 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.
- Results publication: PubMed 34937662Nagel 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.
- Individual participant dataSharing planned: No. 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.
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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.
Rukiye TÜRK DELİBALTA study director
Kafkas University Faculty Of Health Sciences
Şevin POLAT principal investigator
Kafkas University Faculty Of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AWARENESS-BASED COGNITIVE THERAPY in people with Mother Fetus Relations and Health Behavior, run by Kafkas 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 6 inclusion and 5 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 5 Feb 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 SEVİN POLAT (05438082242 ext. 2396, sevin.akgun@erzurum.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring breast milk cortisol value (time frame: 4 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06240676, which also lists 7 linked publications.
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 5 Feb 2024.