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

Primary Purpose

Mother-Infant Interaction, Premature Birth

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Baby smell
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mother-Infant Interaction focused on measuring mother milk, stress, mother baby bonding, premature

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Eskisehir Osmangazi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mothers using baby scent

Mothers who do not use baby scent

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

amount of breast milk

Secondary Outcome Measures

mother baby attachment scale
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.
salivary cortisol level

Full Information

First Posted
October 4, 2023
Last Updated
October 20, 2023
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT06096961
Brief Title
The Effect Of Baby Smell On The Amount Of Breast Milk, Salivary Cortisol Level And Mother Baby Attachment
Official Title
The Effect Of Baby Smell On The Amount Of Breast Milk, Salivary Cortisol Level And Mother Baby Attachment: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mother-Infant Interaction, Premature Birth
Keywords
mother milk, stress, mother baby bonding, premature

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two groups in the study: experimental and control groups. 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. Mothers in the intervention group will smell their baby's scented diapers, and mothers in the control group will express their milk without any intervention and record the amount.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mothers using baby scent
Arm Type
Experimental
Arm Description
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.
Arm Title
Mothers who do not use baby scent
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Baby smell
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
mother baby attachment scale
Description
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.
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.
Title
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.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only mothers can participate in the study.
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
OYKU BALI BILGI
Phone
+905074160813
Email
oykubali7@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AYFER ACIKGOZ
Organizational Affiliation
Eskisehir Osmangazi University
Official's Role
Study Director
Facility Information:
Facility Name
Eskisehir Osmangazi University
City
Eskişehir
ZIP/Postal Code
26000
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ÖYKÜ BALİ BİLGİ
Phone
+905074160813
Email
oykubali7@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Links:
URL
https://www.neonatology.org.tr/wp-content/uploads/2020/04/premature_rehber_2018.pdf
Description
Related Info
URL
https://www.who.int/publications/i/item/9789240005648
Description
Related Info
URL
https://www.who.int/news-room/fact-sheets/detail/preterm-birth
Description
Related Info
URL
https://www.resmigazete.gov.tr/eskiler/2011/04/20110419-5.htm
Description
Related Info
Available IPD and Supporting Information:
Available IPD/Information Type
thesis
Available IPD/Information URL
http://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp
Available IPD/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.
Available IPD/Information Type
thesis
Available IPD/Information URL
http://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp
Available IPD/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.
Available IPD/Information Type
thesis
Available IPD/Information URL
http://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp
Available IPD/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.

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

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