Effects of TUMATA and Mozart Music on Sleep and Comfort in NICU Newborns

Condition(s) studied

Investigational drug(s) / intervention(s)

TUMATA Music: Pentatonic music recommended by TÜMATA will be played to newborns through a music player during the intervention period.

Mozart Classical Music: Mozart classical music will be played to newborns through a music player during the intervention period.

Study summary

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

Primary outcome measure(s)

• Sleep latency — From the start of the 45-minute music intervention (minute 0) until sleep onset
  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 — From sleep onset until spontaneous awakening
  The time elapsed from sleep onset until spontaneous awakening will be observed and recorded in minutes by the researcher.
• Neonatal comfort level — Immediately before the intervention, at the 10th minute of the intervention, and immediately after the newborn awakens.
  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.

Trial sites (1)

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