Clinical trial NCT06428929: The Effect of Using Musical and Lighted Baby Crib Mobile on Newborns' Pain and Stress During Blood Draw
Official title: The Effect of Using Musical and Lighted Baby Crib Mobile on Newborns' Pain and Stress During Blood Draw: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 60
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Newborns were randomly assigned groups as the musical and lighted baby crib mobile (intervention) group (40 newborns) and the control group (40 newborns) by the computer program (www.randomizer.org). Newborns of parents who did not meet the study criteria and did not agree to participate in the random selection were not included in the study. Parents and researchers could not be blinded. Newborns were included in the study by evaluating their compliance with the inclusion criteria according to the order of admission to the hospital. 10 children in the control group (5 parents did not volunteer and 5 newborns were crying) and 10 children in the intervention group (7 newborns received paracetamol and 3 newborns were crying) were excluded from the study. For this reason, the research was completed with 60 newborns.
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: Inclusion Criteria:

* born between 38-42 weeks,
* being 0-28 days,
* absence of visual and auditory problems,
* not using any pain reliever or sedative medication in the last four hours,
* parents' willingness to participate in the study,
* parents' knowledge of Turkish,
* parents' ability to read and write.

Exclusion Criteria:

* having a preterm birth,
* having a disease that causes chronic pain,
* having visual or auditory problems,
* using any pain or sedative medication in the last four hours.

Primary outcomes:
measure: ALPS-Neo pain and stress assessment scale
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University
state: Zeytinburnu
Study officials:
affiliation: Koç University
name: Eyşan Savaş, PhD
role: PRINCIPAL_INVESTIGATOR
References: