Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615323
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
The Effect of Polyphonic Lullaby and Pish Pish Sound on Sleep Transition and Sleep Duration in Newborns
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Polyphonic Lullaby and Pish Pish Sound on Sleep Transition and Sleep Duration in Newborns
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Sleep is the cornerstone of early development Adequate sleep in children is important for proper growth development and the childs health Sleep is a dynamic process that develops and matures rapidly especially in the first few years of life from infancy to early adolescence Daily sleep duration decreases with age starting from the newborn period At birth babies show a sleep process that is compatible with their mothers circadian rhythm Newborns usually wake up in line with their nutritional needs and have short transitional sleep periods At approximately 10-12 weeks of age the first signs of circadian rhythm begin to develop and become apparent with increased sleep during the night It has been reported that music positively affects mother-infant bonding reduces babies stress and creates positive physiological and behavioral changes In a study examining mothers views and practices on singing lullabies it was seen that 876 of mothers said that singing lullabies soothes their children and prepares them for sleep 883 prefer to sing lullabies before going to sleep while preparing their children for sleep and 662 sing lullabies Therefore it is thought that the research will fill this gap in newborns
Detailed Description:
Sleep is the cornerstone of early development At approximately 10-12 weeks of age the first signs of the circadian rhythm begin to develop and become evident with increased nighttime sleep The change in the total 24-hour sleep duration decreases as the baby grows gradually adapting to the circadian sleep rhythm Daily sleep duration in newborns decreases to 16-17 hours 14-15 hours at 16 weeks of age and 13-14 hours at 6 months of age As the baby grows the need for daytime sleep decreases resulting in a shift towards more nighttime sleep patterns In recent years studies examining the effects of music especially on newborns have increased Music is a complex auditory stimulus consisting of various components such as melody rhythm timbre and harmony When adults listen to music these components are perceived as a phenomenological whole but they are processed separately through a complex dual cortical and subcortical regions Since the adult human brain does not have a single musical center the neural substrates supporting musical perception and production vary depending on the musical task Neuroimaging studies in neonates or infants have reported inconsistent results regarding cortical activation in response to musical stimuli While two studies showed weak bilateral responses to musical stimuli results from a functional magnetic resonance imaging fMRI study used to measure brain activity in 1- to 3-day-old neonates hearing excerpts of Western tone music and modified versions of the same excerpts suggest that the infant brain shows hemispheric specialization in right-lateralized auditory cortex activity for processing music in the early postnatal hours and that the neural architecture underlying music processing in neonates is sensitive to changes in tone key as well as differences in consonance and dissonance It has been found that infants can maintain distinct memory traces for polyphonic music and show a high preference for polyphonic music from 3 months onwards Marie and Trainor 2014 hypothesize that this high-volume advantage may be mediated at the level of the auditory nerve at birth In general the presence of immature mismatch negativity MMN occurs when there is an occasional change or deviant stimulus in a continuing standard stimulus sequence Again this more complex MMN-like response to polyphonic stimuli has been reported to have a longer developmental trajectory than the MMN elicited by a single tone stimulus Early musical involvement is very important for the auditory system which mostly matures in the first 6 months after birth Polyphonic lullabies known in the literature as polyphony consisting of sounds or music are music played especially during the rapid development period 0-4 years of infants and children When the literature was examined no randomized controlled studies were found that revealed the effects of polyphonic lullabies and piş piş sounds on the transition to sleep and sleep duration in healthy newborns It was thought that the research results would provide strong evidence to support the development of approaches to improving sleep in newborns
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