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Clinical Trials/NCT06428929
NCT06428929CompletedNot Applicable

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

Koç University2 sites in 2 countries60 target enrollmentStarted: February 4, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
2
Primary Endpoint
ALPS-Neo pain and stress assessment scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
— to 28 Days (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

ALPS-Neo pain and stress assessment scale

Time Frame: immediately after the intervention

In this study, researchers used a mobile crib to help reduce pain in infants during needle procedures. Our primary outcome was the level of pain experienced by the infants. Pain was assessed using standardized pain assessment tools that are suitable for neonates. By comparing pain scores during the needle procedures, researchers aimed to determine the effectiveness of the mobile crib in reducing the infants' pain levels.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Koç University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eysan Hanzade Umac

Research Assistant

Koç University

Study Sites (2)

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