Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05647005 |
| Other study ID # |
2022/48 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2022 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Selcuk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
