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

NCT06428929 | Completed

• 1 other identifier: EysanUmac
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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:

Interventions

The musical and lighted baby crib mobile: OTHER

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

Intervention

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, Zeytinburnu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eyşan Savaş, PhD

  Koç University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 24, 2024
• Study Start: February 4, 2022
• Primary Completion: July 30, 2022
• Study Completion: July 31, 2022
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)