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Clinical Trials/NCT05578079
NCT05578079
Completed
Not Applicable

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

Izmir Katip Celebi University1 site in 1 country60 target enrollmentOctober 14, 2022
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Izmir Katip Celebi University
Enrollment
60
Locations
1
Primary Endpoint
Baby's heart rate
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 14, 2022
End Date
April 25, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Izmir Katip Celebi University
Responsible Party
Principal Investigator
Principal Investigator

Pınar Dogan

Research Ass.

Izmir Katip Celebi University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Baby's heart rate

Time Frame: 2 minutes after collecting heel blood

The baby's pulse rate will be measured.

Baby's respiratory rate

Time Frame: 2 minutes after collecting heel blood

The baby's respiratory rate will be measured.

Premature Infant Pain Profile (PIPP)

Time Frame: 2 minutes after collecting heel blood

PIPP scores will be evaluated separately by two experts in the field.

Baby's oxygen saturation

Time Frame: 2 minutes after collecting heel blood

The baby's oxygen saturation will be measured.

Study Sites (1)

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