Clinical trial NCT05253625: The Effect of Lullaby Listened to Preterm Babies in Neonatal Intensive Care Units on Physiological Parameters and Pain
Official title: The Effect of Lullaby Listened to Preterm Babies in Neonatal Intensive Care Units on Physiological Parameters and Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Intensive Care
Music Therapy
Pain Responses
Keywords: premature
pain
lullaby
Lead sponsor: Izmir Tinaztepe University
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 93
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The participants will be assigned to three groups. Before, during and after a painful intervention the first group (Group A) will listen to a lullaby recorded with the mothers voice, the second group (Group B) will listen to a lullaby recorded with a unfamiliar female voice, and the third group (Group C) without and intervention (no lullaby).
Primary purpose: SUPPORTIVE_CARE

Brief summary: Preterms who enter a different environment after the intrauterine period experience an adaptation process and may need special care due to conditions such as developmental disabilities or neurological disorders. In such cases, newborns may frequently be exposed to repetitive painful interventions (like IV catherization). Pain in the postnatal period can cause physiological, behavioral and metabolic changes, and changes in the functional processing related with somatosensation and pain in the long term. In this context, inadequacy in pain control may cause neurodevelopmental and behavioral problems in infants.

For these reasons, it is essential to carefully evaluate the pain status of the newborn and to perform pharmacological and/or non-pharmacological interventions. In the intrauterine 20th week, the ability to hear begins to form, and in the 26-28th weeks the level to respond to sounds is achieved. Music therapy is a method that can be used for newborns as it reaches a level that can respond to sound stimuli within weeks. Especially in the 32nd gestational week, preterm newborns begin to develop the ability to distinguish mother's voice from other sounds with regard to rhythm and intonation. Due to this developmental feature of preterm newborns, it is recommended to use the mother's voice in neonatal intensive care units. However, studies on this subject are very limited.

The main goal of care in neonatal intensive care units is to maintain the baby's life and comfort at the highest level, to minimize pain and suffering, and to ensure that it can cope with pain. In the light of all information, it is essential to strengthen scientific evidence in order to apply non-pharmacological methods in clinics. The research was planned experimentally in order to examine the effects of listening to a lullaby on pain and physiological parameters in preterms hospitalized in neonatal intensive care units. The participants will be devided in three groups. The first group will listen to the lulliby recorded with the mothers voice, the second group will listen to the the lulliby recorded with the voice of an unfamilliar female, and the third group will not listen to a lulliby. The effects will be measured by using three physiologic parameters (oxygen saturation, heart rate, and respiratory rate) and pain responses (Neonatai Infant Pain Scala) before, during, and after a painful intervention (IV catherization).


Eligibility criteria: Inclusion Criteria:

* At 32-36+6 weeks of gestation
* Stable first 24 hours after birth
* Not dependent on mechanical ventilation
* Non-intubated
* Without a congenital and/or acquired malformation of hearing
* No congenital defect • Without hyperbilirinemia
* Not taking analgesics and/or sedatives in the last 24 hours
* If no painful application has been made to the newborn in the last hour (eg, blood collection, aspiration, eye examination, etc.)
* Postnatal age of 1-7 days
* Preterms whose height and weight are above the 10% percentile according to the week of gestation

Exclusion Criteria:

* Deterioration in general condition
* Those who do not meet the criteria for inclusion in the research
* Preterms whose parents did not consent to participate in the study

Primary outcomes:
measure: Change of NIPS (Neonatal Infant Pain Scale) Score
timeFrame: 15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.
measure: Change of SpO2 (Oxygen Concentration)
timeFrame: 15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.
measure: Change of HR (Heart Rate)
timeFrame: 15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.
measure: Change of RR (Respiratory Rate)
timeFrame: 15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Izmir Tinaztepe University
name: Nilüfer Özgürbüz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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