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NCT05578079 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05578079
Other study ID # 05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2022
Est. completion date April 25, 2023

Study information
Verified date July 2023
Source Izmir Katip Celebi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date April 25, 2023
Est. primary completion date April 25, 2023
Accepts healthy volunteers No
Gender All
Age group 32 Weeks to 37 Weeks
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Music
Intervention-1 group will listen to the classical music that the "Arts of Fugue" by Bach.
• Music
Intervention-2 group will listen to lullaby.

Locations
Country Name City State
Turkey Tepecik Research and Training Hospital Izmir

Sponsors (1)
Lead Sponsor Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

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