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Clinical Trials/NCT05333575
NCT05333575
Completed
Not Applicable

The Effect of Lullaby and Classic Music to Prematures During Orogastric Tub Feeding on the Baby's Cerebral Oxygenization, Vital Findings and Comfort

Selcuk University2 sites in 1 country51 target enrollmentDecember 2, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nutrition Disorder, Infant
Sponsor
Selcuk University
Enrollment
51
Locations
2
Primary Endpoint
Body temperature (°C)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2, 2020
End Date
April 4, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sibel Küçükoğlu

Assoch Prof

Selcuk University

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).

Outcomes

Primary Outcomes

Body temperature (°C)

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Time Frame: 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)

Time Frame: 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 Outcomes

  • Regional brain oxygen saturation (rSO2) levels(Second measurement - immediately after feeding)
  • Heart rate (minute)(Second measurement - immediately after feeding)
  • Body temperature (°C)(Second measurement - immediately after feeding)
  • Oxygen saturation (%SpO2)(Second measurement - immediately after feeding)
  • Respiratory rate (min)(Second measurement - immediately after feeding)
  • COMFORTneo Scale(Second measurement - immediately after feeding)

Study Sites (2)

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