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

NCT ID: NCT06058208

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-19
• Study Completion Date: 2023-09-13

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.

Conditions

Cesarean Delivery Affecting Fetus; Preterm Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Baby Smell Group

Firstly the baby beret worn by the researcher on the baby will be removed at the end of the 12th hour (at the 12th hour and 24th hour of the hospitalization in the clinic) and taken to the Obstetrics and Gynecology Service on the same floor as the NICU without waiting;Odor stimulation will be applied in the form of 30 sec odor-30 sec standby-30 sec odor-30 sec standby-30 sec odor. A total of 4 rSO2 values, including the initial value and the average of the values during three 30 sec stimulation, will be recorded in the "Cortical and Breast Oxygenation Follow-up Form". The amount of the first amount of milk, the total amount of milk until the 12th hour, the amount of oral fluid intake, the amount of milk until the 24th hour (12th hour -24th hour) and the amount of oral fluid intake will be recorded in the Milk Amount Follow-up Form.

Group Type: EXPERIMENTAL

Olfactory stimulation

Intervention Type: BEHAVIORAL

Olfactory stimulation: Mothers will be made to smell their babies' odor.

Baby Smell and Visual Stimulus Group

Firstly the baby video (visual stimulus) and beret worn by the researcher on the baby will be removed at the end of the 12th hour (at the 12th hour and 24th hour of the hospitalization in the clinic) taken by researcher and taken to the clinic on the same floor as the NICU without waiting; Once the initial rSO2 value has been recorded, the mother will be instructed to sniff the beret uninterruptedly until further warning by the researcher and to watch the image of her baby unfolding on the tablet fixed to the floor during the entire measurement process. Odor stimulation to the mother will be applied in the form of 30 sec odor-30 sec waiting-30 sec odor-30 sec waiting-30 sec odor respectively, and visual stimulation will be applied as uninterrupted 2.5 min. At the end of 24 hours, the Mother-Baby Interaction Form and the MIBS tool will be re-applied as the final test.

Group Type: EXPERIMENTAL

Olfactory stimulation

Intervention Type: BEHAVIORAL

Olfactory stimulation: Mothers will be made to smell their babies' odor.

Visual stimulation

Intervention Type: BEHAVIORAL

Mothers will be shown video images of their babies.

Control Group

The intervention and data collection process in the control group is the same as the intervention in the odor group; As a placebo instead of odor stimulation, the odorless beret will be offered in the same conditions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Olfactory stimulation

Olfactory stimulation: Mothers will be made to smell their babies' odor.

Intervention Type: BEHAVIORAL

Visual stimulation

Mothers will be shown video images of their babies.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Sibel Küçükoğlu

Proffessor Doktor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sibel Küçükoğlu, Prof

Role: PRINCIPAL_INVESTIGATOR

Selcuk University

Locations

Selcuk University

Konya, Selcuklu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 28932343 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 30700979 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32306871 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21705961 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15868385 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

SelcukUnı4244

Identifier Type: -

Identifier Source: org_study_id