The Effect Of Baby Smell On The Amount Of Breast Milk, Salivary Cortisol Level And Mother Baby At… (NCT06096961) | Clinical Trial Compass
UnknownNot Applicable
The Effect Of Baby Smell On The Amount Of Breast Milk, Salivary Cortisol Level And Mother Baby Attachment
Turkey (Türkiye)60 participantsStarted 2023-11-01
Plain-language summary
The goal of this \[type of study: randomized controlled clinical trial\] is to \[determine the effect of applying the scent of premature newborns who cannot be breastfed to the mother on the mother's milk amount, salivary cortisol level and mother-infant attachment.\] in \[mothers of premature babies\]. The main question\[s\] it aims to answer are:
* \[Hypothesis 1: There is a difference in the amount of milk of the mother.\]
* \[Hypothesis 2: There is a difference in the level of cortisol in the mother's saliva.\]
* \[Hypothesis 3: There is a difference in terms of mother-baby attachment level.\] Participants will \[Participants will express milk and record the amount of milk.\].
If there is a comparison group: Researchers will compare \[control and experimental groups\] to see if \[difference in amount of milk, cortisol level, baby attachment\].
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Mother's acceptance of the application
* Ability to communicate with the mother (being literate, speaking Turkish, etc.)
* Gestational week being 34 weeks or less
* The newborn is in the NICU
Exclusion Criteria:
* The newborn's gestational age is over 34 weeks
* The mother is breastfeeding her baby
* Being a smoker (Ahmed et al. 2019)
* The mother is unable to express milk due to a serious chronic disease or pregnancy complication.
* The mother has a breast problem that may affect milk expression (cracked, mastitis, collapse, etc.).
* If the mother uses milk-boosting drinks or food
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
amount of breast milk
Timeframe: Mothers participating in the study will express their milk every three hours for four days and record the amount of milk.