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

The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants: A Double-Blind Randomized Controlled Trial

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 Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Music; Other: Music

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

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey
    • Tepecik Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 8 months (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No music will be played to the control group.
Active Comparator: Intervention 1; 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.	Other: Music; Intervention-1 group will listen to the classical music that the "Arts of Fugue" by Bach.; Other: Music; Intervention-2 group will listen to lullaby.
Active Comparator: Intervention 2; The Intervention-2 group will listen to lullaby.	Other: Music; Intervention-1 group will listen to the classical music that the "Arts of Fugue" by Bach.; Other: Music; Intervention-2 group will listen to lullaby.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University
• Investigators: Study Chair: Defne ENGUR, Assoc.Prof., Tepecik Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2022
• Primary Completion (Actual): April 25, 2023
• Study Completion (Actual): April 25, 2023

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Premature; Music
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: 05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No