Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428929
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2024-05-15
Brief Title:
The Effect of Using Musical and Lighted Baby Crib Mobile on Newborns Pain and Stress During Blood Draw
Sponsor:
Koç University
Organization:
Koç University
Study Overview
Official Title:
The Effect of Using Musical and Lighted Baby Crib Mobile on Newborns Pain and Stress During Blood Draw Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
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:
It is widely recognized that the use of non-pharmacological methods in neonatal pain management is low both globally and in our country Nurses play a crucial role in managing pain through various techniques and in preventing its negative effects on newborns Toys with sounds lights and different features have been found to effectively capture infants attention Consequently it is anticipated that baby crib mobiles which combine these attention-grabbing features could serve as effective distractions during needle interventions potentially reducing pain and stress However there is a lack of research on this specific application
Detailed Description:
Newborns often undergo needle procedures shortly after birth such as vitamin K injections hepatitis B vaccinations screenings and routine immunizations Depending on the babys condition these procedures may need to be repeated and additional blood samples might be required These painful procedures can cause significant stress for the newborn and may lead to neurocognitive physiological metabolic and behavioral issues Pain experienced during these procedures can negatively impact the newborns future reactions to pain Therefore inadequate pain management can result in both immediate and long-term adverse effects
Organizations such as the International Neuropsychiatric Pain Group and the American Academy of Pediatrics advocate for reducing pain in infants during procedures recommending non-pharmacological methods as the first line of management These methods aimed at providing analgesic effects by creating a relaxing environment are important because they do not have side effects Some proven non-pharmacological techniques include breastfeeding skin-to-skin contact swaddling music therapy oral glucose and pacifier use
Music therapy is a widely used non-pharmacological method that helps reduce pain perception in newborns Studies have shown its effectiveness in various settings For instance research with premature newborns found that music therapy during central venous catheter placement reduced physiological and behavioral reactions Another study with 120 healthy newborns reported that having a musical baby crib mobile in vaccination rooms decreased pain levels and crying times Other studies have similarly highlighted the positive effects of listening to or singing lullabies during painful procedures
Organizations such as the International Neuropsychiatric Pain Group and the American Academy of Pediatrics advocate for reducing pain in infants during procedures recommending non-pharmacological methods as the first line of management These methods aimed at providing analgesic effects by creating a relaxing environment are important because they do not have side effects Some proven non-pharmacological techniques include breastfeeding skin-to-skin contact swaddling music therapy oral glucose and pacifier use
Music therapy is a widely used non-pharmacological method that helps reduce pain perception in newborns Studies have shown its effectiveness in various settings For instance research with premature newborns found that music therapy during central venous catheter placement reduced physiological and behavioral reactions Another study with 120 healthy newborns reported that having a musical baby crib mobile in vaccination rooms decreased pain levels and crying times Other studies have similarly highlighted the positive effects of listening to or singing lullabies during painful procedures
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