Ignite Creation Date:
2024-05-06 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05253625
Status:
UNKNOWN
Last Update Posted:
2022-03-08
First Post:
2022-01-31
Brief Title:
The Effect of Lullaby Listened to Preterm Babies in Neonatal Intensive Care Units on Physiological Parameters and Pain
Sponsor:
Izmir Tinaztepe University
Organization:
Izmir Tinaztepe University
Study Overview
Official Title:
The Effect of Lullaby Listened to Preterm Babies in Neonatal Intensive Care Units on Physiological Parameters and Pain
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Preterms who enter a different environment after the intrauterine period experience an adaptation process and may need special care due to conditions such as developmental disabilities or neurological disorders In such cases newborns may frequently be exposed to repetitive painful interventions like IV catherization Pain in the postnatal period can cause physiological behavioral and metabolic changes and changes in the functional processing related with somatosensation and pain in the long term In this context inadequacy in pain control may cause neurodevelopmental and behavioral problems in infants
For these reasons it is essential to carefully evaluate the pain status of the newborn and to perform pharmacological andor non-pharmacological interventions In the intrauterine 20th week the ability to hear begins to form and in the 26-28th weeks the level to respond to sounds is achieved Music therapy is a method that can be used for newborns as it reaches a level that can respond to sound stimuli within weeks Especially in the 32nd gestational week preterm newborns begin to develop the ability to distinguish mothers voice from other sounds with regard to rhythm and intonation Due to this developmental feature of preterm newborns it is recommended to use the mothers voice in neonatal intensive care units However studies on this subject are very limited
The main goal of care in neonatal intensive care units is to maintain the babys life and comfort at the highest level to minimize pain and suffering and to ensure that it can cope with pain In the light of all information it is essential to strengthen scientific evidence in order to apply non-pharmacological methods in clinics The research was planned experimentally in order to examine the effects of listening to a lullaby on pain and physiological parameters in preterms hospitalized in neonatal intensive care units The participants will be devided in three groups The first group will listen to the lulliby recorded with the mothers voice the second group will listen to the the lulliby recorded with the voice of an unfamilliar female and the third group will not listen to a lulliby The effects will be measured by using three physiologic parameters oxygen saturation heart rate and respiratory rate and pain responses Neonatai Infant Pain Scala before during and after a painful intervention IV catherization
For these reasons it is essential to carefully evaluate the pain status of the newborn and to perform pharmacological andor non-pharmacological interventions In the intrauterine 20th week the ability to hear begins to form and in the 26-28th weeks the level to respond to sounds is achieved Music therapy is a method that can be used for newborns as it reaches a level that can respond to sound stimuli within weeks Especially in the 32nd gestational week preterm newborns begin to develop the ability to distinguish mothers voice from other sounds with regard to rhythm and intonation Due to this developmental feature of preterm newborns it is recommended to use the mothers voice in neonatal intensive care units However studies on this subject are very limited
The main goal of care in neonatal intensive care units is to maintain the babys life and comfort at the highest level to minimize pain and suffering and to ensure that it can cope with pain In the light of all information it is essential to strengthen scientific evidence in order to apply non-pharmacological methods in clinics The research was planned experimentally in order to examine the effects of listening to a lullaby on pain and physiological parameters in preterms hospitalized in neonatal intensive care units The participants will be devided in three groups The first group will listen to the lulliby recorded with the mothers voice the second group will listen to the the lulliby recorded with the voice of an unfamilliar female and the third group will not listen to a lulliby The effects will be measured by using three physiologic parameters oxygen saturation heart rate and respiratory rate and pain responses Neonatai Infant Pain Scala before during and after a painful intervention IV catherization
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None