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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: The musical and lighted baby crib mobile:

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Zeytinburnu
    • Istanbul, Zeytinburnu, Turkey
      • Koç University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Infants in the control group received standard care, with no pharmacological or non-pharmacological methods used to reduce pain, except for allowing the parents to be present. Parents and nurses observed the infant's behavior during and immediately after the procedure to assess pain and stress. After the procedure, they were asked to mark the maximum pain and stress experienced by the baby on the "ALPS-Neo pain and stress rating scale." This assessment was done immediately after the needle was removed and a tampon was placed to stop the bleeding, approximately one minute after the procedure.
Experimental: Intervention; Before the procedure, the researcher informed the parents of the newborns in the musical and lighted baby crib mobile group about the study procedure and purpose. The mobile was fixed 60 cm above the newborn's eye level to prevent contamination and trauma. After obtaining written consent, the researcher collected data using the 'Newborn Information Form' through face-to-face interviews. Once the form was completed, the mobile was activated. One minute later, the nurse performed the blood draw. Parents and nurses observed the infant's behavior during and immediately after the procedure to assess pain and stress. They were then asked to mark the maximum pain and stress experienced by the baby on the ALPS-Neo pain and stress rating scale.	Other: The 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ALPS-Neo pain and stress assessment scale	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.	immediately after the intervention

Collaborators and Investigators

• Sponsor: Koç University
• Investigators: Principal Investigator: Eyşan Savaş, PhD, Koç University

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2022
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EysanUmac

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No