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Clinical Trials/NCT06096961
NCT06096961
Not Yet Recruiting
N/A

The Effect Of Baby Smell On The Amount Of Breast Milk, Salivary Cortisol Level And Mother Baby Attachment: A Randomized Controlled Study

Eskisehir Osmangazi University1 site in 1 country60 target enrollmentNovember 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mother-Infant Interaction
Sponsor
Eskisehir Osmangazi University
Enrollment
60
Locations
1
Primary Endpoint
amount of breast milk
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief 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].

Detailed Description

The study was planned as a randomized controlled study to determine the effect of applying the scent of non-breastfeedable premature newborns to the mother on the mother's milk quantity, salivary cortisol level and mother-baby bonding. The study is planned to be conducted with the mothers of premature infants whose babies are hospitalized in the Neonatal Intensive Care Unit of Bursa City Hospital. There will be two groups in the study: study and control group. For each group, 30 mothers will be included in the study. The study will continue for four days. The mothers in the experimental group will be given the gowns that their babies wear for 12 hours and they will be asked to smell these gowns during the milking process. On the 1st day, mothers in both groups will be trained on expressing and storing breast milk (frequency of expressing milk, appropriate speed of the pump, milk storage bags, room temperature, storage times in the refrigerator and freezer). All mothers will be ensured to express their milk with the same milk pumps. Mothers will be provided with a syringe to measure their milk. The mothers will be asked to express their milk at three-hour intervals and record the amount measured. Mothers in the experimental group will be asked to smell their babies' scented clothes during the milking process. A sample will be taken from the mothers to look at the cortisol level in saliva. Data collection forms will be filled in. On the 2nd and 3rd day, mothers will be asked to express their milk at three-hour intervals and record the amount they measured on the mother follow-up form. The mothers in the experimental group will be asked to smell their babies' smelly clothes during the milking process. On the 4th day, mothers will be asked to express their milk at three-hour intervals and record the amount they measured on the mother follow-up form. The mothers in the experimental group will be asked to smell their babies' scented clothes during the milking process. The mothers will be sampled again to check the cortisol level in saliva. Mother-infant attachment scale will be applied.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
April 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Eskisehir Osmangazi University
Responsible Party
Principal Investigator
Principal Investigator

Öykü Bali

Principal Investigator

Eskisehir Osmangazi University

Eligibility Criteria

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

Outcomes

Primary Outcomes

amount of breast milk

Time Frame: Mothers participating in the study will express their milk every three hours for four days and record the amount of milk.

Secondary Outcomes

  • mother baby attachment scale(The mother-infant attachment scale will be applied to the mothers participating in the study on the first and fourth day of the study.)
  • salivary cortisol level(Saliva cortisol test will be applied to the mothers participating in the study on the first and fourth day of the study.)

Study Sites (1)

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