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

Primary Purpose

Nutrition Disorder, Infant, Music, Preterm

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lullaby
Classic music
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutrition Disorder, Infant focused on measuring preterm babies, cerebral oxygenation, lullabies, classical music

Eligibility Criteria

28 Weeks - 34 Weeks (Child)All SexesAccepts Healthy Volunteers

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,

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).

Sites / Locations

  • Selcuk University
  • Sibel Kucukoglu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Experimental Group: Lullaby

Experimental Group: Classic Music

Control Group

Arm Description

The mothers in this group sang lullabies to their babies next to the incubator during feeding.

Babies in this group were listened to classical music during feeding.

Premature newborns in the control group were fed according to the routine of the clinic and no intervention was performed other than routine practice.

Outcomes

Primary Outcome Measures

Newborn Information Form
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.
Regional brain oxygen saturation (rSO2) levels
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.
Heart rate (minute)
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.
Oxygen saturation (%SpO2)
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.
Body temperature (°C)
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.
Respiratory rate (min)
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
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.

Secondary Outcome Measures

Regional brain oxygen saturation (rSO2) levels
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)
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.
Oxygen saturation (%SpO2)
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.
Body temperature (°C)
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.
Respiratory rate (min)
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
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.

Full Information

First Posted
April 4, 2022
Last Updated
April 11, 2022
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT05333575
Brief Title
Lullaby and Classic Music's Effect on Vital Findings and Comfort
Official Title
The Effect of Lullaby and Classic Music to Prematures During Orogastric Tub Feeding on the Baby's Cerebral Oxygenization, Vital Findings and Comfort
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
April 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorder, Infant, Music, Preterm, Vital Signs
Keywords
preterm babies, cerebral oxygenation, lullabies, classical music

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Research 28-34 preterm babies with gestational age hospitalized in the 2nd and 3rd level intensive care unit of Selcuk University Medical Faculty Hospital in Konya, Turkey. As a result of the power analysis, it was determined that the inclusion of 45 preterm infants in the study would provide sufficient sample size based on the two-sided hypothesis, 1.392 effect size, 0.05 margin of error and 0.95 power. Since the study period coincided with a period of uncertainties such as the Covid 19 pandemic, it was foreseen that there may be a loss in the number of babies included in the groups, and the sample number was increased by 10%, and the study was completed with a total of 51 premature babies (maternal voice group: 17, control group 17, classical music group 17).Babies of mothers who agreed to participate in the study were randomly assigned to the experimental and control groups. Simple randomization method was used in the study.
Masking
Participant
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group: Lullaby
Arm Type
Experimental
Arm Description
The mothers in this group sang lullabies to their babies next to the incubator during feeding.
Arm Title
Experimental Group: Classic Music
Arm Type
Experimental
Arm Description
Babies in this group were listened to classical music during feeding.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Premature newborns in the control group were fed according to the routine of the clinic and no intervention was performed other than routine practice.
Intervention Type
Behavioral
Intervention Name(s)
Lullaby
Intervention Description
The mothers in this group were asked to sing a lullaby while their babies were fed with an orogastric tube. Mothers were released on lullabies. They were encouraged to sing the lullaby they knew or loved the most. The mother was given a sound decibel meter. Mothers were asked to do an application before going to the baby. It was taught that the number of sound decibels should not exceed 40 decibels while singing a lullaby. Later, the mother was taken to the baby's incubator at feeding time. She was seated in a chair. The working status of the decibel meter was checked and given to the mother. When the feeding started, the mother started singing lullabies and continued to sing until the feeding was finished. Attention was paid to aseptic techniques during all procedures. A single mother was asked to sing a lullaby at each feeding, and the baby of the mother who sang only a lullaby was included in the study.
Intervention Type
Behavioral
Intervention Name(s)
Classic music
Intervention Description
The babies in this group were given classical music recitals during feeding. The classical music piece Mozart-Baby Smart was preferred because it was seen to be used in the literature (Keidar 2014). Mozart-Baby Smart was loaded into the music player by the researcher before the feeding process. Before feeding, the decibel meter was disinfected by surface disinfectant and placed on sterile sponge in an incubator 10 cm away from the baby's head. The music player was turned on, not exceeding 40 decibels, by adjusting the decibel meter at the time of starting the feeding, and classical music was continued during the feeding. When the feeding was finished, the music player was turned off and the incubator was taken out. Attention was paid to acetic techniques during all procedures. Ambient sounds were tried to be controlled as much as possible so that the baby would not be affected by different sounds when listening to classical music.
Primary Outcome Measure Information:
Title
Newborn Information Form
Description
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.
Time Frame
First measurement - Before intervention
Title
Regional brain oxygen saturation (rSO2) levels
Description
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.
Time Frame
First measurement - one minute before the baby is fed
Title
Heart rate (minute)
Description
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.
Time Frame
First measurement - one minute before the baby is fed
Title
Oxygen saturation (%SpO2)
Description
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.
Time Frame
First measurement - one minute before the baby is fed
Title
Body temperature (°C)
Description
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.
Time Frame
First measurement - one minute before the baby is fed
Title
Respiratory rate (min)
Description
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.
Time Frame
First measurement - one minute before the baby is fed
Title
COMFORTneo Scale
Description
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.
Time Frame
First measurement - one minute before the baby is fed
Secondary Outcome Measure Information:
Title
Regional brain oxygen saturation (rSO2) levels
Description
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.
Time Frame
Second measurement - immediately after feeding
Title
Heart rate (minute)
Description
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.
Time Frame
Second measurement - immediately after feeding
Title
Oxygen saturation (%SpO2)
Description
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.
Time Frame
Second measurement - immediately after feeding
Title
Body temperature (°C)
Description
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.
Time Frame
Second measurement - immediately after feeding
Title
Respiratory rate (min)
Description
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.
Time Frame
Second measurement - immediately after feeding
Title
COMFORTneo Scale
Description
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.
Time Frame
Second measurement - immediately after feeding

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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, 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibel Kucukoglu, PhD
Organizational Affiliation
Selcuk University
Official's Role
Study Chair
Facility Information:
Facility Name
Selcuk University
City
Konya
ZIP/Postal Code
42100
Country
Turkey
Facility Name
Sibel Kucukoglu
City
Konya
ZIP/Postal Code
42100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It will be shared after the article is published.
Citations:
PubMed Identifier
24232665
Citation
Keidar HR, Mandel D, Mimouni FB, Lubetzky R. Bach music in preterm infants: no 'Mozart effect' on resting energy expenditure. J Perinatol. 2014 Feb;34(2):153-5. doi: 10.1038/jp.2013.138. Epub 2013 Nov 14.
Results Reference
background
PubMed Identifier
23589814
Citation
Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15.
Results Reference
background
PubMed Identifier
29045255
Citation
Caparros-Gonzalez RA, de la Torre-Luque A, Diaz-Piedra C, Vico FJ, Buela-Casal G. Listening to Relaxing Music Improves Physiological Responses in Premature Infants: A Randomized Controlled Trial. Adv Neonatal Care. 2018 Feb;18(1):58-69. doi: 10.1097/ANC.0000000000000448.
Results Reference
background
PubMed Identifier
26153174
Citation
Azarmnejad E, Sarhangi F, Javadi M, Rejeh N. The Effect of Mother's Voice on Arterial Blood Sampling Induced Pain in Neonates Hospitalized in Neonate Intensive Care Unit. Glob J Health Sci. 2015 Apr 19;7(6):198-204. doi: 10.5539/gjhs.v7n6p198.
Results Reference
background
PubMed Identifier
23890458
Citation
Alipour Z, Eskandari N, Ahmari Tehran H, Eshagh Hossaini SK, Sangi S. Effects of music on physiological and behavioral responses of premature infants: a randomized controlled trial. Complement Ther Clin Pract. 2013 Aug;19(3):128-32. doi: 10.1016/j.ctcp.2013.02.007. Epub 2013 May 9.
Results Reference
background
PubMed Identifier
19692803
Citation
van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.
Results Reference
background
Citation
Kahraman A, Başbakkal Z, Yalaz M, 2014. Yenidoğan Konfor Davranış Ölçeği'nin Türkçe geçerlik ve güvenirliği. Uluslararası Hakemli Hemşirelik Araştırmaları Dergisi, 1, 2, 1-11.
Results Reference
background

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

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