The Effect Of Baby Smell On The Amount Of Breast Milk, Salivary Cortisol Level And Mother Baby Attachment
1 other identifier
interventional
60
1 country
1
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 \[difference in amount of milk, cortisol level, baby attachment\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2023
CompletedFirst Posted
Study publicly available on registry
October 24, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedOctober 24, 2023
October 1, 2023
5 months
October 4, 2023
October 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (2)
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 Arms (2)
Mothers using baby scent
EXPERIMENTALMothers 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 who do not use baby scent
NO INTERVENTIONMothers 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eskisehir Osmangazi University
Eskişehir, 26000, Turkey (Türkiye)
Related Publications (21)
Akkoca Z, Yigit D, Acikgoz A. The Effect of Neonates' Exposure to Their Mother's Scent on Weight Gain: A Randomized Controlled Study. Breastfeed Med. 2022 Jan;17(1):79-84. doi: 10.1089/bfm.2021.0274. Epub 2021 Dec 22.
PMID: 34939823BACKGROUNDCakirli M, Acikgoz A. A Randomized Controlled Trial: The Effect of Own Mother's Breast Milk Odor and Another Mother's Breast Milk Odor on Pain Level of Newborn Infants. Breastfeed Med. 2021 Jan;16(1):75-81. doi: 10.1089/bfm.2020.0222. Epub 2020 Oct 20.
PMID: 33085532BACKGROUNDChrustek A, Dombrowska-Pali A, Olszewska-Slonina D. Analysis of the composition and antioxidant status of breast milk in women giving birth prematurely and on time. PLoS One. 2021 Jul 23;16(7):e0255252. doi: 10.1371/journal.pone.0255252. eCollection 2021.
PMID: 34297788BACKGROUNDHolditch-Davis D, Santos H, Levy J, White-Traut R, O'Shea TM, Geraldo V, David R. Patterns of psychological distress in mothers of preterm infants. Infant Behav Dev. 2015 Nov;41:154-63. doi: 10.1016/j.infbeh.2015.10.004. Epub 2015 Oct 22.
PMID: 26495909BACKGROUNDAk J, Lakshmanagowda PB, G C M P, Goturu J. Impact of music therapy on breast milk secretion in mothers of premature newborns. J Clin Diagn Res. 2015 Apr;9(4):CC04-6. doi: 10.7860/JCDR/2015/11642.5776. Epub 2015 Apr 1.
PMID: 26023551BACKGROUNDMiller J, Tonkin E, Damarell RA, McPhee AJ, Suganuma M, Suganuma H, Middleton PF, Makrides M, Collins CT. A Systematic Review and Meta-Analysis of Human Milk Feeding and Morbidity in Very Low Birth Weight Infants. Nutrients. 2018 May 31;10(6):707. doi: 10.3390/nu10060707.
PMID: 29857555BACKGROUNDMontirosso R, Provenzi L, Calciolari G, Borgatti R; NEO-ACQUA Study Group. Measuring maternal stress and perceived support in 25 Italian NICUs. Acta Paediatr. 2012 Feb;101(2):136-42. doi: 10.1111/j.1651-2227.2011.02440.x. Epub 2011 Sep 14.
PMID: 21827551BACKGROUNDNeu M, Hazel NA, Robinson J, Schmiege SJ, Laudenslager M. Effect of holding on co-regulation in preterm infants: a randomized controlled trial. Early Hum Dev. 2014 Mar;90(3):141-7. doi: 10.1016/j.earlhumdev.2014.01.008. Epub 2014 Jan 27.
PMID: 24480604BACKGROUNDRojas MA, Kaplan M, Quevedo M, Sherwonit E, Foster L, Ehrenkranz RA, Mayes L. Somatic growth of preterm infants during skin-to-skin care versus traditional holding: a randomized, controlled trial. J Dev Behav Pediatr. 2003 Jun;24(3):163-8. doi: 10.1097/00004703-200306000-00006.
PMID: 12806228BACKGROUNDTasci B, Kuzlu Ayyildiz T. The Calming Effect of Maternal Breast Milk Odor on Term Infant: A Randomized Controlled Trial. Breastfeed Med. 2020 Nov;15(11):724-730. doi: 10.1089/bfm.2020.0116. Epub 2020 Oct 29.
PMID: 33121256BACKGROUNDTaylor A, Atkins R, Kumar R, Adams D, Glover V. A new Mother-to-Infant Bonding Scale: links with early maternal mood. Arch Womens Ment Health. 2005 May;8(1):45-51. doi: 10.1007/s00737-005-0074-z. Epub 2005 May 4.
PMID: 15868385BACKGROUNDTrend S, Strunk T, Lloyd ML, Kok CH, Metcalfe J, Geddes DT, Lai CT, Richmond P, Doherty DA, Simmer K, Currie A. Levels of innate immune factors in preterm and term mothers' breast milk during the 1st month postpartum. Br J Nutr. 2016 Apr 14;115(7):1178-93. doi: 10.1017/S0007114516000234. Epub 2016 Feb 19.
PMID: 26891901BACKGROUNDAhmed, F., Jean-Baptiste, F., Thompson, A., Nwokorie, U., Nya, G. E., & Bassey, G. O. . Effects of maternal tobacco smoking on breast milk composition and infant development: a literature review. J Bacteriol Mycol Open Access. 2019; 7(5): 107-110.
BACKGROUNDAydemir Karakulak, H, Alparslan, Ö. Anne-bebek bağlanma ölçeğinin türk toplumuna uyarlanması: Aydın örneği . Çağdaş Tıp Dergisi. 2016; 6 (3) : 188-199 .
BACKGROUNDDabas S, Joshi P, Agarwal R, Yadav RK, & Kachhawa G. Impact of audio assisted relaxation technique on stress, anxiety and milk output among postpartum mothers of hospitalized neonates: A randomized controlled trial. Journal of Neonatal Nursing. 2019; 25(4): 200-204.
BACKGROUNDDe Clifford-Faugère G, Aita M, Héon M,& Le May S. Management of procedural pain in preterm infants through olfactive stimulation with mothers' milk: A pilot study. Science of Nursing and Health Practices. 2019; 2(1): 1-13.
BACKGROUNDKömürcü B. Erken doğan bebek annelerinde travma sonrası stres: ilişkili etmenler ve müdahale çalışmaları üzerine bir derleme. Nesne-Psikoloji Dergisi. 2020; 8(16): 158-170.
BACKGROUNDMerter ÖS, Altay N. Yenidoğan yoğun bakımda izlenen prematüre bebeklerin anne sütü ile beslenme durumlarının değerlendirilmesi. Gazi Sağlık Bilimleri Dergisi. 2020; 5 (1): 21-29.
BACKGROUNDÖzlü F, Tunç A, Yıldızdaş HY, & Büyükkurt S. Geç prematüre doğan bebeklerin postnatal ilk 15 günde karşılaştıkları sorunların değerlendirilmesi. Çocuk Sağlığı ve Hastalıkları Dergisi. 2017; 60(2): 39-54.
BACKGROUNDSuzan ÖK. Kolostrum: Özellikleri ve prematüre bebeğe faydaları. Sürekli Tıp Eğitimi Dergisi. 2020; 29(3): 221-227
BACKGROUNDVarışoğlu Y, Güngör Satılmış İ. Preterm doğumlarda anne sütü ve anne sütünü artırmaya yönelik alternatif yöntemler . Izmir Democracy University Health Sciences Journal. 2019; 2 (2): 99-113 .
BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AYFER ACIKGOZ
Eskisehir Osmangazi University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 4, 2023
First Posted
October 24, 2023
Study Start
November 1, 2023
Primary Completion
April 1, 2024
Study Completion
April 1, 2024
Last Updated
October 24, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share