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

Sponsor
Eskisehir Osmangazi University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06096961
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
5
Anticipated Duration (Months)
12
Patients Per Site Per Month

Study Details

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].

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Baby smell
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Double (Participant, Care Provider)
Primary Purpose:
Health Services Research
Official Title:
The Effect Of Baby Smell On The Amount Of Breast Milk, Salivary Cortisol Level And Mother Baby Attachment: A Randomized Controlled Study
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. amount of breast 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

  1. 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.]

    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.

  2. 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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eskisehir Osmangazi University Eskişehir Turkey 26000

Sponsors and Collaborators

  • Eskisehir Osmangazi University

Investigators

  • Study Director: AYFER ACIKGOZ, Eskisehir Osmangazi University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Öykü Bali, Principal Investigator, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier:
NCT06096961
Other Study ID Numbers:
  • OYKUCALISMA
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Öykü Bali, Principal Investigator, Eskisehir Osmangazi University
mother milk
stress
mother baby bonding
premature
Additional relevant MeSH terms:
Premature Birth

Study Results

No Results Posted as of Oct 24, 2023