Lullaby and Classic Music's Effect on Vital Findings and Comfort

Not Applicable

Completed

• Conditions: Nutrition Disorder, Infant; Preterm; Vital Signs; Music
• Interventions: Behavioral: Classic music; Behavioral: Lullaby

• Registration Number: NCT05333575
• Lead Sponsor: Selcuk University

Brief Summary

In the study, lullabies and classical music played to preterm babies during orogastric tube feeding; It will be tried to determine the effect on cerebral oxygenation level, vital signs and comfort levels.

Detailed Description

In the literature, there are many studies on prematurity pain and its relief. Although the vital signs and comfort levels of infants were examined in many applications for infants hospitalized in the neonatal intensive care unit, no study was found in which the cerebral oxygenation levels of infants were evaluated by NIRS by listening to lullabies and classical music to premature infants. There is no study in the literature examining cerebral oxygenation, vital signs and comfort parameters together during orogastric tube feeding, which is frequently used in preterm infants. For this reason, in this study, lullabies and classical music played to preterm babies during orogastric tube feeding; It will be tried to determine the effect on cerebral oxygenation level, vital signs and comfort levels. It is thought that the study will present new data to the literature and will lead many researches.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-12-02
• Primary Completion: 2021-12-15
• Status Verified: 2022-04
• Study Completion: 2022-04-04
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-11
• Last Update Submitted: 2022-04-11
• Study First Posted: 2022-04-19
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Being at 28-34 weeks of gestation,
• Stability (in terms of cerebral oxygenation, pain and vital signs) during enrollment,
• Not having any additional diagnosis other than the diagnosis of prematurity,
• Indication of bolus feeding with an orogastric tube,

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Exclusion Criteria

• Congenital anomaly in the baby
• Diagnosed hearing impairment in the baby
• Having a history of an invasive procedure (such as a surgical operation) that will disrupt the baby's long-term comfort and cause pain
• The baby is receiving oxygen therapy or the baby is on mechanical ventilation
• Any history of disease affecting cerebral oxygenation (such as intraventricular hemorrhage, neonatal convulsions).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Experimental Group: Classic Music	Classic music	Babies in this group were listened to classical music during feeding.
Experimental Group: Lullaby	Lullaby	The mothers in this group sang lullabies to their babies next to the incubator during feeding.

Primary Outcome Measures

Name	Time	Method
Body temperature (°C)	First measurement - one minute before the baby is fed	The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's body temperature (°C) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Heart rate (minute)	First measurement - one minute before the baby is fed	The form prepared by the researcher; It was prepared in such a way that physiological parameters such as heart rate (min) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
COMFORTneo Scale	First measurement - one minute before the baby is fed	The scale is a Likert type scale developed to determine the pain, distress, sedation and comfort needs of newborns followed in the intensive care unit. Ambuel et al. created the Comfort Scale in 1992 to evaluate the distress of children receiving mechanical ventilator support in pediatric intensive care units. Van Dijk et al. revised the scale in 2009 and made the validity and reliability of the COMFORTneo scale only to measure newborn behavior without vital parameters. The Turkish validity and reliability of the scale was performed by Kahraman et al. in 2014. The lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6, and the highest score is 30. High scores indicate that the baby is not comfortable and needs interventions to provide comfort.
Newborn Information Form	First measurement - Before intervention	This form was developed by the researcher using the literature (Loewy et al 2013, Caparros-Gonzalez et al 2018, Azarmnejad et al 2015, Alipour et al 2013). The form was composed of questions including introductory information about the baby, gestational age, postnatal age, gender, birth weight (gr), weight on the day of the intervention, type of delivery, 1st and 5th min apgar score.
Oxygen saturation (%SpO2)	First measurement - one minute before the baby is fed	The form prepared by the researcher; It was prepared in such a way that physiological parameters such as Oxygen saturation (%SpO2) were recorded.. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Regional brain oxygen saturation (rSO2) levels	First measurement - one minute before the baby is fed	The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's rSO2 levels were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Respiratory rate (min)	First measurement - one minute before the baby is fed	The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's respiratory rate (min) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.

Secondary Outcome Measures

Name	Time	Method
Regional brain oxygen saturation (rSO2) levels	Second measurement - immediately after feeding	The form prepared by the researcher; It was prepared in such a way that physiological parameters such as Oxygen saturation (%SpO2) were recorded.. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Heart rate (minute)	Second measurement - immediately after feeding	The form prepared by the researcher; It was prepared in such a way that physiological parameters such as heart rate (min) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Body temperature (°C)	Second measurement - immediately after feeding	The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's body temperature (°C) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Oxygen saturation (%SpO2)	Second measurement - immediately after feeding	The form prepared by the researcher; It was prepared in such a way that physiological parameters such as Oxygen saturation (%SpO2) were recorded.. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Respiratory rate (min)	Second measurement - immediately after feeding	The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's respiratory rate (min) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
COMFORTneo Scale	Second measurement - immediately after feeding	The scale is a Likert type scale developed to determine the pain, distress, sedation and comfort needs of newborns followed in the intensive care unit. Ambuel et al. created the Comfort Scale in 1992 to evaluate the distress of children receiving mechanical ventilator support in pediatric intensive care units. Van Dijk et al. revised the scale in 2009 and made the validity and reliability of the COMFORTneo scale only to measure newborn behavior without vital parameters. The Turkish validity and reliability of the scale was performed by Kahraman et al. in 2014. The lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6, and the highest score is 30. High scores indicate that the baby is not comfortable and needs interventions to provide comfort.

Trial Locations

Locations (2)

Selcuk University; 🇹🇷 Konya, Turkey

Sibel Kucukoglu; 🇹🇷 Konya, Turkey