Clinical Trials Directory

Trials / Completed

CompletedNCT06428929

The Effect of Using Musical and Lighted Baby Crib Mobile on Newborns' Pain and Stress During Blood Draw

The Effect of Using Musical and Lighted Baby Crib Mobile on Newborns' Pain and Stress During Blood Draw: Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Koç University · Academic / Other
Sex
All
Age
28 Days
Healthy volunteers
Accepted

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 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.

Conditions

Interventions

TypeNameDescription
OTHERThe musical and lighted baby crib mobile:The musical and lighted baby crib mobile: It measures 43.5x33x9.5 cm and is made of plastic. It is recommended for use in infants 0-12 months. It has music that makes it easier for babies to fall asleep by reducing stress. This baby mobile has a projection and music function. In addition, the mobile has a 360° flexible swivel bracket that can be adjusted as desired. The surface of the apparatus of the mobile, which is designed to be environmentally and baby friendly, is smooth. There are four rattles on the mobile

Timeline

Start date
2022-02-04
Primary completion
2022-07-30
Completion
2022-07-31
First posted
2024-05-24
Last updated
2024-05-24

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06428929. Inclusion in this directory is not an endorsement.