The Effect of Two Different Types of Music Played in a Neonatal Intensive Care Unit on Newborns' Sleep and Comfort Levels: A Crossover Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Sleep latency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Due to the nature of the music interventions, participants, care providers, investigators, and outcome assessors could not be blinded. The statistician performing the data analysis will be blinded to the intervention codes.
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •The infant must have finished feeding at least 30 minutes prior to the procedure.
- •The infant must not have received any analgesics and/or sedatives within the last 8 hours.
- •The parents must have consented to participate in the study.
- •The infant must have been admitted for at least 24 hours.
排除标准
- •Newborns readmitted during the data collection period.
- •Newborns with respiratory problems.
- •Newborns whose parents declined to participate in the study.
- •Criteria for Withdrawal from the Study:
- •A change in the newborn's vital signs.
- •The parent's request to withdraw the newborn from the study.
研究组 & 干预措施
Mozart Classical 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.
干预措施: Mozart Classical Music (Other)
TÜMATA Music
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.
干预措施: TUMATA Music (Other)
Routine Care
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.
结局指标
主要结局
Sleep latency
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Dr. Hatice Dönmez
Associate Professor
Karamanoğlu Mehmetbey University