Clinical trial NCT06058208: Baby Smell Visual Stimulus Program Cortical and Breast Oxygenation Milk Amount Mother-Infant Attachment
Official title: The Effect of Baby Smell and Visual Stimulus Program on Mothers' Cortical and Breast Oxygenation, Milk Amount and Mother-Infant Attachment: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Delivery Affecting Fetus
Preterm Labor
Keywords: breastmilk
cortical and breast oxygenation
infant odor
mother-infant bonding
NIRS
visual stimulus
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 54
Sex: ALL
Minimum age (years): 28
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this randomized controlled study, "block randomization" method, which is one of the "fixed probability randomization" methods, was used in randomization. Each of the experimental and control groups was represented by one of the letters A, B, C. In the creation of the 6-block (2A, 2B, 2C) design for 54 samples and three groups; Using the "permutation" method, the assignment of 9 blocks out of 90 block options was carried out through the random numbers table on the www.random.org site. Which of the experimental and control groups will match the letters A, B, C; It was determined by the lottery method drawn by hand by the independent clinical nurse from the study. As a result of the draw, A: smell, B: smell + video, C: represented the control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the effect of infant odor and visual stimulus program applied to mothers who had delivered by cesarean section and whose babies were taken to the NICU on cortical and breast oxygenation (rSO2), amount of breast milk and mother-infant bonding was investigated.

Detailed description: One of the conditions that prevent the preterm baby from being close to the mother in the early period is cesarean delivery and subsequent removal to the NICU. In the first hour of life, the process immediately after birth, when the newborn is alert, makes eye contact, focuses, finds the unaided mother's breast and begins to feed, deteriorates in babies in need of intensive care and mothers begin the experience of parenting with delayed attachment. The mother experiences high levels of stress due to changes in many parental roles such as being physically separated from her baby, not being able to breastfeed effectively, not being able to care for her baby and the intensive care environment, and experiencing a delay in lactation with the effect of cesarean delivery. In the literature, many interventions have been implemented to reduce the negative effects of mother-infant separation on lactation and attachment in mothers who have given birth by cesarean section. However, there is no published research examining the effect of infant odor and visual stimulus program applied to mothers who had delivered by cesarean section and whose babies were taken to the NICU on cortical and breast oxygenation (rSO2), amount of breast milk and mother-infant bonding. In addition, being able to assess how the mother's cortical and breast oxygenation changes while smelling her baby's scent and watching her/his video will further strengthen the results of the measurement tools.

Eligibility criteria: Inclusion Criteria:

Infant

* Born at 28-37 (36+6) weeks of gestation
* Admission to the NICU in the same hospital as the mother immediately after birth Mother
* To agree to participate in the study,
* To give birth by cesarean section,
* To be able to use the Turkish language,
* To pass the smell test (to correctly identify the 3 different types of smell presented),
* Not to have been diagnosed with depression etc. Psychiatry at the time of the study

Exclusion Criteria:

Infant

* The presence of conditions that affect the baby's original smell (baby born with Meconium, Hepatitis C and HIV infected baby)
* Infant who underwent interventional intervention in the head area
* The baby whose suction function is sufficient and who can suck breast milk

Mother

* Admission to Intensive Care,
* Being covid positive (as the sense of smell will be affected),
* Having a mental, neurological, nasal related disease,
* Having a communication problem

Primary outcomes:
measure: Cortical and Breast Oxygenation Follow-up Parameter
timeFrame: First measurement- At 12th hour of the postpartum period.
measure: Cortical and Breast Oxygenation Follow-up Parameter
timeFrame: Second measurement- At 24th hour of the postpartum period.
measure: Milk Amount Follow-up Form
timeFrame: First measurement- At 12th hour of the postpartum period.
measure: Milk Amount Follow-up Form
timeFrame: Second measurement- At 24th hour of the postpartum period.
measure: Mother to Infant Bonding Scale
timeFrame: First measurement- Within 1 hour of the postpartum period.
measure: Mother to Infant Bonding Scale
timeFrame: Second measurement- At 24th hour of the postpartum period.
measure: Mother and Infant Information Tool
timeFrame: First measurement- Within 1 hour of the postpartum period.
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
affiliation: Selcuk University
name: Sibel Küçükoğlu, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Croy I, Frackowiak T, Hummel T, Sorokowska A. Babies Smell Wonderful to Their Parents, Teenagers Do Not: an Exploratory Questionnaire Study on Children's Age and Personal Odor Ratings in a Polish Sample. Chemosens Percept. 2017;10(3):81-87. doi: 10.1007/s12078-017-9230-x. Epub 2017 Jun 27.
citation: Durkaya Göktepe, G., 2021. "Maternal infant bonding and affecting factors in the early period in women who have term and preterm birth" Unpublished Master's Thesis, Istanbul University-Cerrahpaşa Graduate Education Institute, Istanbul
citation: Karakulak, H.A., Alparslan, Ö., 2016. "Adaptation of Mother to Infant Bonding Scale to The Turkish Society: Aydın Sample", Çağdaş Journal of Medicine, 6(3), 188-199.
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citation: Schafer L, Sorokowska A, Sauter J, Schmidt AH, Croy I. Body odours as a chemosignal in the mother-child relationship: new insights based on an human leucocyte antigen-genotyped family cohort. Philos Trans R Soc Lond B Biol Sci. 2020 Jun 8;375(1800):20190266. doi: 10.1098/rstb.2019.0266. Epub 2020 Apr 20.
citation: Tanimoto K, Kusaka T, Nishida T, Ogawa K, Kato I, Ijichi S, Mikami J, Sobue I, Isobe K, Itoh S. Hemodynamic changes in the breast and frontal cortex of mothers during breastfeeding. Pediatr Res. 2011 Oct;70(4):400-5. doi: 10.1203/PDR.0b013e31822a363a.
citation: 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.
citation: Turhan, İ., 2020. "The effect of monitoring the video image of the baby on the mother's milk and maternal connectivity to the mother in the newborn unit of the infant" (Unpublished Master's Thesis), Erciyes University/ Institute of Health Sciences, Kayseri.