About this trial
This study aims to evaluate the effects of two different types of music played in the neonatal intensive care unit on newborns' sleep and comfort levels. In this prospective, single-blind, crossover randomized controlled trial, newborns will receive TÜMATA music, Mozart classical music, and routine care (control) in different study periods. Sleep duration and comfort levels will be assessed using validated measurement tools to determine the effectiveness of music interventions in improving newborn comfort and sleep in the neonatal intensive care unit.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The infant must be in the neonatal period (aged 0-28 days).
The infant must have been admitted to the Neonatal Intensive Care Unit.
The infant must have been born at term (38 weeks or more).
The infant must be breathing spontaneously.
Disqualifiers
Newborns readmitted during the data collection period.
Newborns with respiratory problems.
Newborns whose parents declined to participate in the study.
A change in the newborn's vital signs.
Trial design
Crossover
Treatments tested in this trial
TUMATA Music
Other interventionPentatonic music recommended by TÜMATA will be played to newborns through a music player during the intervention period.
Mozart Classical Music
Other interventionMozart classical music will be played to newborns through a music player during the intervention period.
Treatment groups
Trial outcomes
Primary outcomes
Sleep latency
Sleep latency is defined as the time elapsed from the start of the music intervention (minute 0) until the newborn falls asleep. The time will be observed and recorded in minutes by the researcher.
Total sleep duration
The time elapsed from sleep onset until spontaneous awakening will be observed and recorded in minutes by the researcher.
Neonatal comfort level
Newborn Comfort Behavior Scale The Scale (NICS) is a Likert-type scale consisting of six parameters: wakefulness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. In addition to determining comfort, the Neonatal Comfort Behavior Scale (NICS) is an assessment tool that includes quantitative rating scales to enable nurses to evaluate the baby's pain and distress. Each item on the scale is scored from 1 to 5. The total score is evaluated. The lowest possible score on the Neonatal Comfort Behavior Scale (NICS) is 6, and the highest is 30. If the total score is between 14 and 30, it indicates that the baby is in pain or distress, is uncomfortable, and requires interventions to provide comfort. Nurses or observers assess infants' pain and distress based on observations using numerical rating scales ranging from 0 to 10. Scores of 4-6 indicate moderate pain and distress, while scores of 7-10 indicate severe pain and distress.
Sponsors and contacts
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