Clinical trial NCT05333575: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Disorder, Infant
Music
Preterm
Vital Signs
Keywords: preterm babies
cerebral oxygenation
lullabies
classical music
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 51
Sex: ALL
Minimum age (years): 28
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Newborn Information Form
timeFrame: First measurement - Before intervention
measure: Regional brain oxygen saturation (rSO2) levels
timeFrame: First measurement - one minute before the baby is fed
measure: Heart rate (minute)
timeFrame: First measurement - one minute before the baby is fed
measure: Oxygen saturation (%SpO2)
timeFrame: First measurement - one minute before the baby is fed
measure: Body temperature (°C)
timeFrame: First measurement - one minute before the baby is fed
measure: Respiratory rate (min)
timeFrame: First measurement - one minute before the baby is fed
measure: COMFORTneo Scale
timeFrame: First measurement - one minute before the baby is fed
Secondary outcomes:
measure: Regional brain oxygen saturation (rSO2) levels
timeFrame: Second measurement - immediately after feeding
measure: Heart rate (minute)
timeFrame: Second measurement - immediately after feeding
measure: Oxygen saturation (%SpO2)
timeFrame: Second measurement - immediately after feeding
measure: Body temperature (°C)
timeFrame: Second measurement - immediately after feeding
measure: Respiratory rate (min)
timeFrame: Second measurement - immediately after feeding
measure: COMFORTneo Scale
timeFrame: Second measurement - immediately after feeding
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
city: Konya
country: Turkey
facility: Sibel Kucukoglu
Study officials:
affiliation: Selcuk University
name: Sibel Kucukoglu, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.