Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514352
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
The Effect of Skin-to-Skin Contact Based on Clinical Guidelines
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Skin-to-Skin Contact Based on Clinical Guidelines on Newborn Stress and Breastfeeding Success
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Newborn health indicators are important data that provide information about the welfare level of countries Health professionals and relevant institutions have important responsibilities in protecting developing and ensuring the continuity of newborn health Health professionals use evidence-based practices revealed by scientific studies in their care approaches Care and follow-up immediately after birth are very important When the investigators look at the neonatal mortality rate in our country in 2019 it is shown as 53 per thousand and 5 per thousand in 2020 Therefore neonatal-specific programs and practices need to be strengthened in order to reduce both neonatal and postneonatal death rates
Midwives are the professional group that is with both the mother and the newborn during the birth and postpartum period can initiate breastfeeding in the early period and ensure optimal continuation of breastfeeding
It is very important that the basic health indicators of the newborn improve and that the mother and newborn are monitored at certain standards during and after birth These monitoring must be done according to the criteria Genç et al in 2022 to initiate and maintain skin-to-skin contact with the newborn during the postpartum period 2023 skin-to-skin contact will be made between the mother and the newborn in accordance with the Skin-to-Skin Contact and Kangaroo Care Clinical Practice Guide
Midwives are the professional group that is with both the mother and the newborn during the birth and postpartum period can initiate breastfeeding in the early period and ensure optimal continuation of breastfeeding
It is very important that the basic health indicators of the newborn improve and that the mother and newborn are monitored at certain standards during and after birth These monitoring must be done according to the criteria Genç et al in 2022 to initiate and maintain skin-to-skin contact with the newborn during the postpartum period 2023 skin-to-skin contact will be made between the mother and the newborn in accordance with the Skin-to-Skin Contact and Kangaroo Care Clinical Practice Guide
Detailed Description:
Newborn health indicators are important data that provide information about the welfare level of countries Health professionals and relevant institutions have important responsibilities in protecting developing and ensuring the continuity of newborn health Health professionals use evidence-based practices revealed by scientific studies in their care approaches Care and follow-up immediately after birth are very important When the investigators look at the neonatal mortality rate in our country in 2019 it is shown as 53 per thousand and 5 per thousand in 2020 Therefore neonatal-specific programs and practices need to be strengthened in order to reduce both neonatal and postneonatal death rates
Midwives are the professional group that is with both the mother and the newborn during the birth and postpartum period can initiate breastfeeding in the early period and ensure optimal continuation of breastfeeding
It is very important that the basic health indicators of the newborn improve and that the mother and newborn are monitored at certain standards during and after birth These monitoring must be done according to the criteria Genç et al in 2022 to initiate and maintain skin-to-skin contact with the newborn during the postpartum period 2023 skin-to-skin contact will be made between the mother and the newborn in accordance with the Skin-to-Skin Contact and Kangaroo Care Clinical Practice Guide
Skin-to-skin contact SC is the placement of the baby on the mothers chest for at least one hour at birth or immediately after birth A healthy full-term baby who receives SC after birth directs himself to his mothers breast and nipple and starts sucking for about an hour This application has many benefits for mother and baby If the investigators look at the benefits for the mother earlier separation of the placenta reduced postpartum bleeding increased breastfeeding self-efficacy and reduced maternal stress levels In addition the increase in the mothers oxytocin level in the first hour after birth ensures the development and strengthening of bonding between mother and baby The benefits for the baby are These include reducing the negative consequences that may develop due to birth stress effective thermoregulation crying less and for a shorter period of time reducing the likelihood of apnea less physiological weight loss and less stress response to painful procedures At the same time while SC reduces the rate of formula supplementation in the hospital it has been shown to increase the initiation of breastfeeding and the level of exclusive breastfeeding leading to a successful first breastfeeding and optimal breastfeeding
SC application time and durations vary SC at birth or immediately after birth The newborn is placed face to face on the mothers abdomen or chest within the first minute after birth If medically necessary suctioning can be done while on the mothers abdomen or chest and the baby is dried thoroughly To prevent heat loss the babys back is covered with a pre-warmed blanket and a hat is placed on his head All other interventions with the newborn can be postponed until at least the end of the first hour after birth or the first successful breastfeeding
Very early SC Within the first 30-40 minutes after birth after the first and emergency intervention is given to the newborn in need of intervention the newborn is placed face down on the mothers bare chest naked with or without a hat The newborns back can be covered with a blanket
Early SC It can begin any time between the first hour and 24 hours after birth The baby is naked with or without a diaper and placed face down on the mothers bare chest between the breasts The mother can wear a blouse or shirt that opens at the front or a hospital gown that can be tied at the back The baby is placed inside the apron so that only the head is exposed What the mother wears how the baby is kept warm and what is placed on the babys back may vary The most important thing is that the mother and baby are in direct skin-to-skin contact and the baby is kept dry and warm
A thesis study was planned to examine the relationship between skin-to-skin contact which will be applied within the framework of these application timings and neonatal stress and suckling success
The thesis study was planned as a randomized controlled experimental study The thesis is planned to be carried out at Tarsus State Hospital Maternity Room between August 2024 and January 2025
The population of the study will be women who applied to Tarsus State Hospital Maternity Room for birth between the dates of the study The sample consists of 48 group 1 - sc immediately after birth 48 group 2 - very early sc 48 group 3 - early sc 48 control group who met the selection criteria agreed to participate in the thesis study and were determined by power analysis It will consist of a total of 192 women
As data collection tools socio-demographic characteristics introduction and questionnaire for skin contact and breastfeeding process Skin Contact and Breastfeeding Process Follow-up Form LATCH Breastfeeding Diagnosis Measurement Tool and Newborn Stress Scale will be used
Socio-Demographic Characteristics Introduction and Questionnaire for Skin Contact and Breastfeeding Process The form prepared by the researchers consists of 22 questions regarding the socio-demographic characteristics of the mothers and their spouses the obstetric characteristics of the mothers and the newborn
Skin Contact and Breastfeeding Process Follow-up Form The form was created by researchers This is the form in which information about the time when mothers start to apply skin-to-skin contact the duration of skin-to-skin contact the time to start breastfeeding the duration of breastfeeding and the time for the baby to settle on the breast will be recorded
LATCH Breastfeeding Diagnostic Measurement Tool Breastfeeding status of mothers in the intervention and control groups in the postpartum period will be evaluated using the LATCH scale LATCH Breastfeeding Diagnostic Measurement Tool was developed in 1986 by observing breastfeeding by healthcare professionals or researchers in the clinic It is an assessment tool that is quick and easy to apply and was created to detect problems that may occur in breastfeeding Scoring is between 0-2 and the maximum score that can be obtained is 10 In the measurement tool that does not have a cut-off point a high score indicates that breastfeeding is successful The reliability study was conducted by Adams and Hewell in 1997 The Turkish reliability study of the scale was conducted by Yenal and Okumuş 2003 and the Chronbach alpha value was found to be 095
Newborn Stress Scale The Newborn Stress Scale developed by Ceylan and Bolışık 2017 to evaluate the stress level in premature babies is suitable for use in term babies Scale items were collected in 8 subgroups in a 3-point Likert type including facial expression body color respiration activity level consolability muscle tone extremities and posture In scoring each subgroup is evaluated between 0-2 points
A minimum of 0 points and a maximum of 16 points are taken from the scale As the score increases the babys stress level increases Cronbachs alpha coefficient has been reported to be between 065-081
Application Steps Group 1- SC Immediately After Birth In the immediate skin-to-skin contact group after birth if the newborn does not need any intervention it will be placed on the mothers chest immediately without cord clamping and skin-to-skin contact will begin An average of 60 minutes of skin contact will be made until the first breastfeeding occurs All routine practices for the newborn in the delivery room except weight measurement will be performed on the mothers chest
Group 2- Very Early SC In the very early SC group skin-to-skin contact will begin within the first 30-40 minutes after birth after the first and emergency intervention is given to the newborn in need of intervention and skin-to-skin contact will be carried out for an average of 60 minutes until the first breastfeeding occurs
Group 3- Early SC For the newborn who needs intervention after birth and for whom skin-to-skin contact cannot be started in the delivery room skin-to-skin contact will begin within the first 24 hours after birth after the newborn becomes stable
Control group No treatment will be performed on the mothers and newborns in the control group and the hospitals routine practices will be carried out
Newborn stress and LATCH score will be evaluated at the 12th and 24th hours after birth in all groups
Midwives are the professional group that is with both the mother and the newborn during the birth and postpartum period can initiate breastfeeding in the early period and ensure optimal continuation of breastfeeding
It is very important that the basic health indicators of the newborn improve and that the mother and newborn are monitored at certain standards during and after birth These monitoring must be done according to the criteria Genç et al in 2022 to initiate and maintain skin-to-skin contact with the newborn during the postpartum period 2023 skin-to-skin contact will be made between the mother and the newborn in accordance with the Skin-to-Skin Contact and Kangaroo Care Clinical Practice Guide
Skin-to-skin contact SC is the placement of the baby on the mothers chest for at least one hour at birth or immediately after birth A healthy full-term baby who receives SC after birth directs himself to his mothers breast and nipple and starts sucking for about an hour This application has many benefits for mother and baby If the investigators look at the benefits for the mother earlier separation of the placenta reduced postpartum bleeding increased breastfeeding self-efficacy and reduced maternal stress levels In addition the increase in the mothers oxytocin level in the first hour after birth ensures the development and strengthening of bonding between mother and baby The benefits for the baby are These include reducing the negative consequences that may develop due to birth stress effective thermoregulation crying less and for a shorter period of time reducing the likelihood of apnea less physiological weight loss and less stress response to painful procedures At the same time while SC reduces the rate of formula supplementation in the hospital it has been shown to increase the initiation of breastfeeding and the level of exclusive breastfeeding leading to a successful first breastfeeding and optimal breastfeeding
SC application time and durations vary SC at birth or immediately after birth The newborn is placed face to face on the mothers abdomen or chest within the first minute after birth If medically necessary suctioning can be done while on the mothers abdomen or chest and the baby is dried thoroughly To prevent heat loss the babys back is covered with a pre-warmed blanket and a hat is placed on his head All other interventions with the newborn can be postponed until at least the end of the first hour after birth or the first successful breastfeeding
Very early SC Within the first 30-40 minutes after birth after the first and emergency intervention is given to the newborn in need of intervention the newborn is placed face down on the mothers bare chest naked with or without a hat The newborns back can be covered with a blanket
Early SC It can begin any time between the first hour and 24 hours after birth The baby is naked with or without a diaper and placed face down on the mothers bare chest between the breasts The mother can wear a blouse or shirt that opens at the front or a hospital gown that can be tied at the back The baby is placed inside the apron so that only the head is exposed What the mother wears how the baby is kept warm and what is placed on the babys back may vary The most important thing is that the mother and baby are in direct skin-to-skin contact and the baby is kept dry and warm
A thesis study was planned to examine the relationship between skin-to-skin contact which will be applied within the framework of these application timings and neonatal stress and suckling success
The thesis study was planned as a randomized controlled experimental study The thesis is planned to be carried out at Tarsus State Hospital Maternity Room between August 2024 and January 2025
The population of the study will be women who applied to Tarsus State Hospital Maternity Room for birth between the dates of the study The sample consists of 48 group 1 - sc immediately after birth 48 group 2 - very early sc 48 group 3 - early sc 48 control group who met the selection criteria agreed to participate in the thesis study and were determined by power analysis It will consist of a total of 192 women
As data collection tools socio-demographic characteristics introduction and questionnaire for skin contact and breastfeeding process Skin Contact and Breastfeeding Process Follow-up Form LATCH Breastfeeding Diagnosis Measurement Tool and Newborn Stress Scale will be used
Socio-Demographic Characteristics Introduction and Questionnaire for Skin Contact and Breastfeeding Process The form prepared by the researchers consists of 22 questions regarding the socio-demographic characteristics of the mothers and their spouses the obstetric characteristics of the mothers and the newborn
Skin Contact and Breastfeeding Process Follow-up Form The form was created by researchers This is the form in which information about the time when mothers start to apply skin-to-skin contact the duration of skin-to-skin contact the time to start breastfeeding the duration of breastfeeding and the time for the baby to settle on the breast will be recorded
LATCH Breastfeeding Diagnostic Measurement Tool Breastfeeding status of mothers in the intervention and control groups in the postpartum period will be evaluated using the LATCH scale LATCH Breastfeeding Diagnostic Measurement Tool was developed in 1986 by observing breastfeeding by healthcare professionals or researchers in the clinic It is an assessment tool that is quick and easy to apply and was created to detect problems that may occur in breastfeeding Scoring is between 0-2 and the maximum score that can be obtained is 10 In the measurement tool that does not have a cut-off point a high score indicates that breastfeeding is successful The reliability study was conducted by Adams and Hewell in 1997 The Turkish reliability study of the scale was conducted by Yenal and Okumuş 2003 and the Chronbach alpha value was found to be 095
Newborn Stress Scale The Newborn Stress Scale developed by Ceylan and Bolışık 2017 to evaluate the stress level in premature babies is suitable for use in term babies Scale items were collected in 8 subgroups in a 3-point Likert type including facial expression body color respiration activity level consolability muscle tone extremities and posture In scoring each subgroup is evaluated between 0-2 points
A minimum of 0 points and a maximum of 16 points are taken from the scale As the score increases the babys stress level increases Cronbachs alpha coefficient has been reported to be between 065-081
Application Steps Group 1- SC Immediately After Birth In the immediate skin-to-skin contact group after birth if the newborn does not need any intervention it will be placed on the mothers chest immediately without cord clamping and skin-to-skin contact will begin An average of 60 minutes of skin contact will be made until the first breastfeeding occurs All routine practices for the newborn in the delivery room except weight measurement will be performed on the mothers chest
Group 2- Very Early SC In the very early SC group skin-to-skin contact will begin within the first 30-40 minutes after birth after the first and emergency intervention is given to the newborn in need of intervention and skin-to-skin contact will be carried out for an average of 60 minutes until the first breastfeeding occurs
Group 3- Early SC For the newborn who needs intervention after birth and for whom skin-to-skin contact cannot be started in the delivery room skin-to-skin contact will begin within the first 24 hours after birth after the newborn becomes stable
Control group No treatment will be performed on the mothers and newborns in the control group and the hospitals routine practices will be carried out
Newborn stress and LATCH score will be evaluated at the 12th and 24th hours after birth in all groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None