Baby Smell Visual Stimulus Program Cortical and Breast Oxygenation Milk Amount Mother-Infant Attachment

Preterm Labor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06058208
• Other study ID #: SelcukUni4244
• Status: Completed
• Phase: N/A
• Start date: August 19, 2022
• Est. completion date: September 13, 2023

Study information

• Verified date: September 2023
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 13, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Delivery Affecting Fetus
• Obstetric Labor, Premature
• Preterm Labor

Intervention

Behavioral:
• Olfactory stimulation
Olfactory stimulation: Mothers will be made to smell their babies' odor.
• Visual stimulation
Mothers will be shown video images of their babies.

Locations

Country	Name	City	State
Turkey	Selcuk University	Konya	Selcuklu

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View 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-Cerrahpasa Graduate Education Institute, Istanbul

Karakulak, H.A., Alparslan, Ö., 2016. "Adaptation of Mother to Infant Bonding Scale to The Turkish Society: Aydin Sample", Çagdas Journal of Medicine, 6(3), 188-199.

Schafer L, Hummel T, Croy I. The Design Matters: How to Detect Neural Correlates of Baby Body Odors. Front Neurol. 2019 Jan 16;9:1182. doi: 10.3389/fneur.2018.01182. eCollection 2018. — View 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. — View 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. — View 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. — View Citation

Turhan, I., 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical and Breast Oxygenation Follow-up Parameter	Form; was created by the researcher in accordance with the literature to record cortical and breast oxygenation (Tanimoto et al., 2011; Schafer et al., 2019). NIRS measurement range was accepted as 15-95 for breast and cortical oxygenation. In the study of Tanimoto et al. (2011), the average of the measurement periods of 30 seconds was taken as the initial value; A 5-minute chart has been generated. Similarly in our study; The initial rSO2 value for both cortical and breast will be recorded, and the average rSO2 value for each block will be recorded during 30 seconds of intervention (smell, odor + visual stimulus, control) repeated 3 times. The form contains two charts with 4 cortical and breast rSO2 recordings for the measurement to be made at two different times (12th and 24th hour of birth)	First measurement- At 12th hour of the postpartum period.
Primary	Cortical and Breast Oxygenation Follow-up Parameter	Form; was created by the researcher in accordance with the literature to record cortical and breast oxygenation (Tanimoto et al., 2011; Schafer et al., 2019). NIRS measurement range was accepted as 15-95 for breast and cortical oxygenation. In the study of Tanimoto et al. (2011), the average of the measurement periods of 30 seconds was taken as the initial value; A 5-minute chart has been generated. Similarly in our study; The initial rSO2 value for both cortical and breast will be recorded, and the average rSO2 value for each block will be recorded during 30 seconds of intervention (smell, odor + visual stimulus, control) repeated 3 times. The form contains two charts with 4 cortical and breast rSO2 recordings for the measurement to be made at two different times (12th and 24th hour of birth)	Second measurement- At 24th hour of the postpartum period.
Primary	Milk Amount Follow-up Form	It was created by the researcher in line with the literature (Turhan, 2020). The form will record the amount of initial milking, the total amount of milk up to the 12th hour, and the amount of oral fluid intake, the total amount of milk between the 12th-24th hour onwards, and the amount of oral fluid intake.	First measurement- At 12th hour of the postpartum period.
Primary	Milk Amount Follow-up Form	It was created by the researcher in line with the literature (Turhan, 2020). The form will record the amount of initial milking, the total amount of milk up to the 12th hour, and the amount of oral fluid intake, the total amount of milk between the 12th-24th hour onwards, and the amount of oral fluid intake.	Second measurement- At 24th hour of the postpartum period.
Primary	Mother to Infant Bonding Scale	The "Mother to Infant Bonding Scale" tool developed by Taylor et al., (2005) was adapted into Turkish by Karakulak Aydemir and Alparslan, (2016). The scale, which is arranged in such a way that it can be applied from the first day after birth and allows the mother to express her feelings towards her baby with a single word, consists of 8 items and is in the form of 4 likerts. The score range of the scale is between 0-24. A high score indicates low bonding.	First measurement- Within 1 hour of the postpartum period.
Primary	Mother to Infant Bonding Scale	The "Mother to Infant Bonding Scale" tool developed by Taylor et al., (2005) was adapted into Turkish by Karakulak Aydemir and Alparslan, (2016). The scale, which is arranged in such a way that it can be applied from the first day after birth and allows the mother to express her feelings towards her baby with a single word, consists of 8 items and is in the form of 4 likerts. The score range of the scale is between 0-24. A high score indicates low bonding.	Second measurement- At 24th hour of the postpartum period.
Primary	Mother and Infant Information Tool	According to the literature (Tanimoto et al., 2011; Croy et al., 2019; Schafer et al., 2020) consists of questions compiled by the researcher including the demographic characteristics of the mother (age, educational status) obstetric and clinical characteristics (pregnancy planning status, anesthesia method), characteristics of the baby (gender, gestational week, birth weight, medical diagnosis, nutrition type).	First measurement- Within 1 hour of the postpartum period.