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

NCT05333575 | Completed

• 1 other identifier: SelcukUniversity
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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.

Conditions

Nutrition Disorder, Infant; Music; Preterm; Vital Signs

Keywords

preterm babies; cerebral oxygenation; lullabies; classical music

Outcome Measures

Primary Outcomes (7)

• 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.

  First measurement - Before intervention

• 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.

  First measurement - one minute before the baby is fed

• 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.

  First measurement - one minute before the baby is fed

• 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.

  First measurement - one minute before the baby is fed

• 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.

  First measurement - one minute before the baby is fed

• 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.

  First measurement - one minute before the baby is fed

• 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.

  First measurement - one minute before the baby is fed

Secondary Outcomes (6)

• Regional brain oxygen saturation (rSO2) levels

  Second measurement - immediately after feeding

• Heart rate (minute)

  Second measurement - immediately after feeding

• Oxygen saturation (%SpO2)

  Second measurement - immediately after feeding

• Body temperature (°C)

  Second measurement - immediately after feeding

• Respiratory rate (min)

  Second measurement - immediately after feeding

Study Arms (3)

Experimental Group: Lullaby

EXPERIMENTAL

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

Behavioral: Lullaby

Experimental Group: Classic Music

EXPERIMENTAL

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

Behavioral: Classic music

Control Group

NO INTERVENTION

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

Interventions

Lullaby BEHAVIORAL

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.

Experimental Group: Lullaby

Classic music BEHAVIORAL

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.

Experimental Group: Classic Music

Eligibility Criteria

• Age: 28 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

• 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).

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (2)

Selcuk University

Konya, 42100, Turkey (Türkiye)

Location

Sibel Kucukoglu

Konya, 42100, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 24232665 BACKGROUND

• 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.

  PMID: 23589814 BACKGROUND

• 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.

  PMID: 29045255 BACKGROUND

• 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.

  PMID: 26153174 BACKGROUND

• 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.

  PMID: 23890458 BACKGROUND

• 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.

  PMID: 19692803 BACKGROUND

• 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.

  BACKGROUND

• Bagli E, Kucukoglu S, Soylu H. The Effect of Lullabies and Classical Music on Preterm Neonates' Cerebral Oxygenation, Vital Signs, and Comfort During Orogastric Tube Feeding: A Randomized Controlled Trial. Biol Res Nurs. 2024 Apr;26(2):181-191. doi: 10.1177/10998004231202404. Epub 2023 Sep 22.

  PMID: 37737114 DERIVED

MeSH Terms

Conditions

Infant Nutrition Disorders; Premature Birth

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sibel Kucukoglu, PhD

  Selcuk University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoch Prof

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 19, 2022
• Study Start: December 2, 2020
• Primary Completion: December 15, 2021
• Study Completion: April 4, 2022
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)