The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Music

• Registration Number: NCT05578079
• Lead Sponsor: Izmir Katip Celebi University

Brief Summary

Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are exposed to various painful procedures. Repetitive and untreated painful procedures have a negative impact on the physiological, cognitive and behavioral development of the baby.

Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding, swaddling, massage, and therapeutic positioning are used to reduce the painful processes that newborns are exposed to in the NICU.

Detailed Description

Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are exposed to various painful procedures. Repetitive and untreated painful procedures have a negative impact on the physiological, cognitive and behavioral development of the baby.

Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding, swaddling, massage, and therapeutic positioning are used to reduce the painful processes that newborns are exposed to in the NICU.

Study Timeline

• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-13
• Study Start: 2022-10-14
• Primary Completion: 2023-04-25
• Study Completion: 2023-04-25
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Parent being voluntary to participate in the study
• Being born at 32-36+6 gestastional week
• The baby's condition is stable
• Having passed hearing test
• Having not congenital malformation

Exclusion Criteria

• Birth weight below 2500 g
• Receiving analgesics or sedatives
• Need for mechanical ventilation
• Heel blood collection is not successful in the first time

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention 1	Music	The Intervention-1 group will listen to the music which determined by the researchers by examining the literature (DOI: 10.4274/jpr.24892). The music which determined by the researchers is "The art of fugue" by Johann Sebastian Bach.
Intervention 2	Music	The Intervention-2 group will listen to lullaby.

Primary Outcome Measures

Name	Time	Method
Baby's heart rate	2 minutes after collecting heel blood	The baby's pulse rate will be measured.
Baby's respiratory rate	2 minutes after collecting heel blood	The baby's respiratory rate will be measured.
Premature Infant Pain Profile (PIPP)	2 minutes after collecting heel blood	PIPP scores will be evaluated separately by two experts in the field.
Baby's oxygen saturation	2 minutes after collecting heel blood	The baby's oxygen saturation will be measured.

Trial Locations

Locations (1)

Tepecik Research and Training Hospital; 🇹🇷 İzmir, Turkey