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Completed

NCT Number: NCT05647005

The Effect of Classical and Harp Music Practice on Premature Infants

Aim of the study is to determine the effects of classical and harp music practice on physiological parameters (heart rate, respiratory rate and oxygen saturation value), cerebral oxygenation value (rSO2) and comfort of premature infants.

It is a parallel, three-group randomized controlled trial with a prospective, pretest, posttest experimental design. The study will be carried out in Selcuk University Medical Faculty Hospital Neonatal Intensive Care Unit (NICU). A total of 84 premature babies will be included in the study, including the group to be listened to classical music (n=28), the group to be listened to harp music (n=28), and the control group (n=28). Triple blocks were created in the computer environment so that the premature infants to be included in the study could be assigned to three study groups using the balanced block randomization method (randomization.com). The randomization will be hidden from the researcher conducting the trial until the administration begins. The researcher will be given 84 envelopes and will begin to open the envelopes when they meet the baby. The researcher will learn which group each baby is in just before the application. Data collection tools; newborn Descriptive Information Form, physiological parameter and rSO2 follow-up form, and Premature infant comfort scale. The rSO2 value will be measured with the NIRS monitor. During the data collection phase, the purpose of the study will be explained to the parents of the premature infants by the researcher first, and informed about the study and consent will be obtained from the parents who agreed to participate in the study through the "Informed Voluntary Consent Form". To venture groups (classical and harp music); After feeding, a music box and a decibel meter will be placed in the incubator and classical music will be turned on at 50-55 dB. Just before the music is played, the premature infants physiological parameters, rSO2 and comfort level will be evaluated and recorded. For 30 minutes, music will be played to the baby according to the intervention group (classical and harp music). After 30 minutes, the baby's physiological parameters, rSO2 and comfort level will be evaluated and recorded again. Each session will be held in this way, a total of 15 sessions of music will be applied to thepremature infants, and the baby's physiological parameters, rSO2 and comfort level will be evaluated and recorded before and after each session. The control group is; premature infants in this group are those who take the clinical routine without being exposed to any music. After feeding, the baby's physiological parameters, rSO2 and comfort level will be evaluated and recorded. They will not be exposed to any music and sound for 30 minutes and there will be no intervention. At the 30th minute, the premature infants physiological parameters, rSO2 and comfort level will be evaluated and recorded. Evaluation of the data will be done in the computer environment with the SPSS (Statistical Package for Social Sciences) 22.0 package program. Partial eta squared will be calculated for the effect size and the significance level will be accepted as p<0.05.

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Key information

Age range

30 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University

Konya, Selcuklu, 42060, Turkey (Türkiye)

About this study

Aim of the study is to determine the effects of classical and harp music practice on physiological parameters (heart rate, respiratory rate and oxygen saturation value), cerebral oxygenation value (rSO2) and comfort of premature infants.

It is a parallel, three-group randomized controlled trial with a prospective, pretest, posttest experimental design. The study will be carried out in Selcuk University Medical Faculty Hospital Neonatal Intensive Care Unit (NICU). A total of 84 premature babies will be included in the study, including the group to be listened to classical music (n=28), the group to be listened to harp music (n=28), and the control group (n=28). Triple blocks were created in the computer environment so that the premature infants to be included in the study could be assigned to three study groups using the balanced block randomization method (randomization.com). The randomization will be hidden from the researcher conducting the trial until the administration begins. The researcher will be given 84 envelopes and will begin to open the envelopes when they meet the baby. The researcher will learn which group each baby is in just before the application. Data collection tools; newborn Descriptive Information Form, physiological parameter and rSO2 follow-up form, and Premature infant comfort scale. The rSO2 value will be measured with the NIRS monitor. During the data collection phase, the purpose of the study will be explained to the parents of the premature infants by the researcher first, and informed about the study and consent will be obtained from the parents who agreed to participate in the study through the "Informed Voluntary Consent Form". To venture groups (classical and harp music); After feeding, a music box and a decibel meter will be placed in the incubator and classical music will be turned on at 50-55 dB. Just before the music is played, the premature infants physiological parameters, rSO2 and comfort level will be evaluated and recorded. For 30 minutes, music will be played to the baby according to the intervention group (classical and harp music). After 30 minutes, the baby's physiological parameters, rSO2 and comfort level will be evaluated and recorded again. Each session will be held in this way, a total of 15 sessions of music will be applied to thepremature infants, and the baby's physiological parameters, rSO2 and comfort level will be evaluated and recorded before and after each session. The control group is; premature infants in this group are those who take the clinical routine without being exposed to any music. After feeding, the baby's physiological parameters, rSO2 and comfort level will be evaluated and recorded. They will not be exposed to any music and sound for 30 minutes and there will be no intervention. At the 30th minute, the premature infants physiological parameters, rSO2 and comfort level will be evaluated and recorded. Evaluation of the data will be done in the computer environment with the SPSS (Statistical Package for Social Sciences) 22.0 package program. Partial eta squared will be calculated for the effect size and the significance level will be accepted as p<0.05.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premature babies born between 30-36+6
  • Postnatal babies at least 5 days old
  • Babies with an APGAR score of 7 and above
  • Babies with spontaneous breathing and stable hemodynamics
  • No history of surgery

Exclusion criteria

  • Babies with congenital hearing loss
  • Babies using sedatives or muscle relaxants
  • Absence of congenital anomalies, metabolic diseases, heart diseases and/or other serious diseases

Treatment and study plan

Classical music

Other

A total of 15 sessions of music will be applied to this group, two or three days a week, on different days, 3 sessions a day. Sessions will be in the form of listening to classical music for 30 minutes after the babies are fed.

Harp music

Other

A total of 15 sessions of music will be applied to this group, two or three days a week, on different days, 3 sessions a day. Sessions will be in the form of listening to harp music for 30 minutes after the babies are fed.

Primary outcomes

  1. rSO2 level

    Time frame: before the intervention and the end of the intervention (30. minutes)

    rSO2 level change

  2. comfort

    Time frame: before the intervention and the end of the intervention (30. minutes)

    comfort level change

Secondary outcomes

  1. Heart rate

    Time frame: before the intervention and the end of the intervention (30. minutes)

    Heart rate change

  2. Respiration rate

    Time frame: before the intervention and the end of the intervention (30. minutes)

    Respiration rate change

  3. SpO2 level

    Time frame: before the intervention and the end of the intervention (30. minutes)

    SpO2 level change

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

The Effect of Classical and Harp Music Practice on Physiological Parameters, Cerebral Oxygenation and Comfort in Premature Infants: A Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 12, 2022
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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