Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06428929 |
| Other study ID # |
EysanUmac |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 4, 2022 |
| Est. completion date |
July 31, 2022 |
Study information
| Verified date |
May 2024 |
| Source |
Koç University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Newborns often undergo needle procedures shortly after birth, such as vitamin K injections,
hepatitis B vaccinations, screenings, and routine immunizations. Depending on the baby's
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 newborn's 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.
