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

Primary Purpose

Cesarean Delivery Affecting Fetus, Preterm Labor

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Olfactory stimulation
Visual stimulation
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cesarean Delivery Affecting Fetus focused on measuring breastmilk, cortical and breast oxygenation, infant odor, mother-infant bonding, NIRS, visual stimulus

Eligibility Criteria

28 Weeks - 37 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Selcuk University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Baby Smell Group

Baby Smell and Visual Stimulus Group

Control Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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)
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)
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.
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.
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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
September 13, 2023
Last Updated
September 25, 2023
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT06058208
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 19, 2022 (Actual)
Primary Completion Date
September 13, 2023 (Actual)
Study Completion Date
September 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Delivery Affecting Fetus, Preterm Labor
Keywords
breastmilk, cortical and breast oxygenation, infant odor, mother-infant bonding, NIRS, visual stimulus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baby Smell Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Baby Smell and Visual Stimulus Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Olfactory stimulation
Intervention Description
Olfactory stimulation: Mothers will be made to smell their babies' odor.
Intervention Type
Behavioral
Intervention Name(s)
Visual stimulation
Intervention Description
Mothers will be shown video images of their babies.
Primary Outcome Measure Information:
Title
Cortical and Breast Oxygenation Follow-up Parameter
Description
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)
Time Frame
First measurement- At 12th hour of the postpartum period.
Title
Cortical and Breast Oxygenation Follow-up Parameter
Description
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)
Time Frame
Second measurement- At 24th hour of the postpartum period.
Title
Milk Amount Follow-up Form
Description
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.
Time Frame
First measurement- At 12th hour of the postpartum period.
Title
Milk Amount Follow-up Form
Description
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.
Time Frame
Second measurement- At 24th hour of the postpartum period.
Title
Mother to Infant Bonding Scale
Description
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.
Time Frame
First measurement- Within 1 hour of the postpartum period.
Title
Mother to Infant Bonding Scale
Description
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.
Time Frame
Second measurement- At 24th hour of the postpartum period.
Title
Mother and Infant Information Tool
Description
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).
Time Frame
First measurement- Within 1 hour of the postpartum period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibel Küçükoğlu, Prof
Organizational Affiliation
Selcuk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selcuk University
City
Konya
State/Province
Selcuklu
ZIP/Postal Code
42100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It will be shared after the article is published.
Citations:
PubMed Identifier
28932343
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.
Results Reference
background
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
Results Reference
background
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.
Results Reference
background
PubMed Identifier
30700979
Citation
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.
Results Reference
background
PubMed Identifier
32306871
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.
Results Reference
background
PubMed Identifier
21705961
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.
Results Reference
background
PubMed Identifier
15868385
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.
Results Reference
background
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.
Results Reference
background

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

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