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Completed

NCT Number: NCT06058208

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

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.

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Key information

Conditions

Cesarean Delivery Affecting Fetus Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Preterm Labor Urogenital Diseases

Age range

28 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University

Konya, Selcuklu, 42100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olfactory stimulation

Behavioral

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

Visual stimulation

Behavioral

Mothers will be shown video images of their babies.

Primary outcomes

  1. Cortical and Breast Oxygenation Follow-up Parameter

    Time frame: First measurement- At 12th hour of the postpartum period.

    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)

  2. Cortical and Breast Oxygenation Follow-up Parameter

    Time frame: Second measurement- At 24th hour of the postpartum period.

    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)

  3. Milk Amount Follow-up Form

    Time frame: First measurement- At 12th hour of the postpartum period.

    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.

  4. Milk Amount Follow-up Form

    Time frame: Second measurement- At 24th hour of the postpartum period.

    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.

  5. Mother to Infant Bonding Scale

    Time frame: First measurement- Within 1 hour of the postpartum period.

    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.

  6. Mother to Infant Bonding Scale

    Time frame: Second measurement- At 24th hour of the postpartum period.

    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.

  7. Mother and Infant Information Tool

    Time frame: First measurement- Within 1 hour of the postpartum period.

    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).

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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