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.
Sleep disturbances and discomfort are common among newborns admitted to neonatal intensive care units because of environmental stimuli and routine nursing procedures. Music interventions have been suggested as a safe, non-pharmacological approach to promote relaxation and improve neonatal well-being. However, evidence regarding the comparative effects of different types of music on newborn sleep and comfort remains limited. The aim of this study is to compare the effects of Turkish Music (TÜMATA), Mozart classical music, and routine care on sleep and comfort levels in newborns hospitalized in a neonatal intensive care unit. This study is designed as a prospective, single-blind, crossover randomized controlled trial. Eligible newborns will receive each intervention according to the randomized crossover sequence. Sleep duration and comfort levels will be assessed using validated measurement tools at predetermined time points. The findings of this study are expected to provide evidence regarding the effectiveness of music interventions in supporting sleep and comfort among newborns in neonatal intensive care units.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
48
Pentatonic music recommended by TÜMATA will be played to newborns through a music player during the intervention period.
Mozart classical music will be played to newborns through a music player during the intervention period.
Karaman Training and Research Hospital
Karaman, Turkey (Türkiye)
RECRUITINGSleep 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.
Time frame: From the start of the 45-minute music intervention (minute 0) until sleep onset
Total sleep duration
The time elapsed from sleep onset until spontaneous awakening will be observed and recorded in minutes by the researcher.
Time frame: From sleep onset until spontaneous awakening
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.
Time frame: Immediately before the intervention, at the 10th minute of the intervention, and immediately after the newborn awakens.
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