An interventional study of TUMATA Music and Mozart Classical Music in Neonatal Intensive Care Unit (NICU), sponsored by Karamanoğlu Mehmetbey University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 0 Days to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Karamanoğlu Mehmetbey University · Not applicable, Interventional, and Supportive care
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.
Karamanoğlu Mehmetbey University is the lead sponsor of 69 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Criteria for Withdrawal from the Study:
Within the scope of this study, pentatonic music, as recommended by TÜMATA, will be applied.Music for newborns will be played in the room using a music player, in accordance with the recommendations of the American Academy of Pediatrics, at a level not exceeding 75 decibels. The sound will be 45 decibels at a distance of 30 cm from the newborn's ear, and the music's decibel level will be adjusted using a decibel meter. The decibel meter used to adjust the music decibel level will be calibrated.The music intervention is planned to be played for 45 minutes in recurring periods. Music sessions will be started and ended at the same times each day.The comfort levels and sleep of the newborns will be assessed and recorded before the procedure. The pre-procedure comfort assessment will be done immediately before the music is played, will be done after 10 minutes of music, and the post-procedure comfort assessment will be done when the newborn wakes up.
Other: TUMATA Music
Within the scope of this study, Mozart Classical Music will be applied.Music for newborns will be played in the room using a music player, in accordance with the recommendations of the American Academy of Pediatrics, at a level not exceeding 75 decibels. The sound will be 45 decibels at a distance of 30 cm from the newborn's ear, and the music's decibel level will be adjusted using a decibel meter. The decibel meter used to adjust the music decibel level will be calibrated.The music intervention is planned to be played for 45 minutes in recurring periods. Music sessions will be started and ended at the same times each day.The comfort levels and sleep of the newborns will be assessed and recorded before the procedure. The pre-procedure comfort assessment will be done immediately before the music is played, will be done after 10 minutes of music, and the post-procedure comfort assessment will be done when the newborn wakes up.
Other: Mozart Classical Music
Participants receive routine neonatal intensive care without music intervention. Standard nursing care is provided according to unit protocols. Sleep and comfort are assessed at the same time points as in the music intervention periods.
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.
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.
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.
Plan to share: No
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Started Mar 2025 (actual). Primary completion is estimated for Dec 2026, 21 months after the start.
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Karamanoğlu Mehmetbey University