NCT06096961

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

October 4, 2023

Last Update Submit

October 20, 2023

Conditions

Keywords

mother milkstressmother baby bondingpremature

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

EXPERIMENTAL

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 who do not use baby scent

NO INTERVENTION

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.

Interventions

Baby smellBEHAVIORAL

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.

Mothers using baby scent

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly mothers can participate in the study.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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)

Location

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: 34939823BACKGROUND
  • Cakirli 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: 33085532BACKGROUND
  • Chrustek 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: 34297788BACKGROUND
  • Holditch-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: 26495909BACKGROUND
  • Ak 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: 26023551BACKGROUND
  • Miller 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: 29857555BACKGROUND
  • Montirosso 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: 21827551BACKGROUND
  • Neu 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: 24480604BACKGROUND
  • Rojas 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: 12806228BACKGROUND
  • Tasci 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: 33121256BACKGROUND
  • Taylor 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: 15868385BACKGROUND
  • Trend 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: 26891901BACKGROUND
  • Ahmed, 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.

    BACKGROUND
  • Aydemir Karakulak, H, Alparslan, Ö. Anne-bebek bağlanma ölçeğinin türk toplumuna uyarlanması: Aydın örneği . Çağdaş Tıp Dergisi. 2016; 6 (3) : 188-199 .

    BACKGROUND
  • Dabas 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.

    BACKGROUND
  • De 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.

    BACKGROUND
  • Kömürcü B. Erken doğan bebek annelerinde travma sonrası stres: ilişkili etmenler ve müdahale çalışmaları üzerine bir derleme. Nesne-Psikoloji Dergisi. 2020; 8(16): 158-170.

    BACKGROUND
  • Merter ÖS, Altay N. Yenidoğan yoğun bakımda izlenen prematüre bebeklerin anne sütü ile beslenme durumlarının değerlendirilmesi. Gazi Sağlık Bilimleri Dergisi. 2020; 5 (1): 21-29.

    BACKGROUND
  • Özlü 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.

    BACKGROUND
  • Suzan ÖK. Kolostrum: Özellikleri ve prematüre bebeğe faydaları. Sürekli Tıp Eğitimi Dergisi. 2020; 29(3): 221-227

    BACKGROUND
  • Varışoğlu 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

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • AYFER ACIKGOZ

    Eskisehir Osmangazi University

    STUDY DIRECTOR

Central Study Contacts

OYKU BALI BILGI

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
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

Available IPD Datasets

thesis Access
thesis Access
thesis Access

Locations