The Effect Of Baby Smell On The Amount Of Breast Milk, Salivary Cortisol Level And Mother Baby Attachment

October 20, 2023 updated by: Öykü Bali, Eskisehir Osmangazi University

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

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].

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

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 Locations

  • Turkey
      • Eskişehir, Turkey, 26000
        • Eskisehir Osmangazi University
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mothers using baby scent
Mothers in the experimental group will be given baby clothes that their babies will wear for 12 hours and will be asked to smell these clothes during the milking process. The work will continue for four days. Saliva cortisol test and mother-infant attachment scale will be applied on the first day and the last day.
Behavioral: Baby smell
Mothers in the experimental group will be given baby clothes that their babies will wear for 12 hours and will be asked to smell these clothes during the milking process.
No Intervention: Mothers who do not use baby scent
Mothers in the control group will express milk without any intervention. The works will continue for 4 days. Saliva cortisol test and mother-baby attachment scale will be applied on the first day and the last day.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mother baby attachment scale
Time Frame: The mother-infant attachment scale will be applied to the mothers participating in the study on the first and fourth day of the study.
This scale, which can be applied from the first day after birth and shows the relationship between the mother's mood and the bond established, allows the mother to express the feelings she feels towards her baby with a single word. The scale, whose original name is "Mother-to-Infant Bonding Scale", was developed by Taylor et al. in 2005. It was adapted into Turkish by Aydemir and Alparslan (2008). The scale is a 4-point Likert type and consists of eight items. Responses consist of four options and are scored between 0 and 3. Since they express positive emotion, the first, fourth and sixth items are scored as 0, 1, 2, 3, and since they express negative emotion, the second, third, fifth, seventh and eighth items are scored as 3, 2, 1, 0. The lowest score that can be obtained is 0, the highest score is 24.
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
Time Frame: Saliva cortisol test will be applied to the mothers participating in the study on the first and fourth day of the study.
Saliva cortisol test will be applied to the mothers participating in the study on the first and fourth day of the study.

Collaborators and Investigators

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

Sponsor

Eskisehir Osmangazi University

Investigators

  • Study Director: AYFER ACIKGOZ, Eskisehir Osmangazi University

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

Helpful Links

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)

November 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OYKUCALISMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. thesis
    Information comments: Kara, A. (2022). Bebekleri yenidoğan yoğun bakım ünitesi'nde yatan annelerde bebek kokusunun anksiyete ve süt miktarına etkisi [Yüksek Lisans Tezi, Marmara Üniversitesi Sağlık Bilimleri Enstitüsü]. YÖK Ulusal Tez Merkezi.
  2. thesis
    Information comments: Turhan İ. (2020). Bebeği yenidoğan ünitesinde yatan annelere bebeğinin video görüntüsünün izletilmesinin anne sütü ve maternal bağlanmaya etkisi [Yüksek Lisans Tezi, Erciyes Üniversitesi Sağlık Bilimleri Enstitüsü]. YÖK Ulusal Tez Merkezi.
  3. thesis
    Information comments: Varişoğlu, Y. (2019). Yenidoğan yoğun bakım ünitesinde prematüre bebeği olan annelere dinletilen müziğin anne sütü üretimine etkisi. [Doktora Tezi, İstanbul Üniversitesi Cerrahpaşa Lisansüstü Eğitim Enstitüsü]. YÖK Ulusal Tez Merkezi.

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.

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