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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Other: Music
* Other: Music


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 32 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature, Pain, Music