THE EFFECT OF BRAHMS' LULLABY PLAYED DURING SPONGE BATH IN THE NEONATAL INTENSIVE CARE UNIT ON NEONATAL COMFORT AND PHYSIOLOGICAL PARAMETERS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Neonatal Comfort (COMFORTneo Scale Score)
研究概览
简要总结
This study aims to examine the effect of playing Brahms' lullaby during sponge bathing on neonatal comfort and physiological parameters in a neonatal intensive care unit. The main questions this study aims to answer are whether listening to Brahms' lullaby during sponge bathing improves neonatal comfort and stabilizes physiological parameters such as heart rate, respiratory rate, oxygen saturation, and body temperature. Researchers will compare newborns who receive sponge bathing accompanied by Brahms' lullaby with those who receive routine sponge bathing without music. A total of 70 newborns who meet the inclusion criteria will be randomly assigned to either an intervention group or a control group. Newborn comfort will be evaluated using the COMFORTneo Scale, and physiological parameters including heart rate, respiratory rate, oxygen saturation, and body temperature will be recorded before and after bathing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns whose parents provide written informed consent for participation
- •Gestational age of 37 weeks or more
- •Birth weight ≥2500 grams
- •Postnatal age between 24 hours and 7 days
- •Newborns who will receive their first bath after birth
- •Physiologically stable newborns
- •Presence of spontaneous breathing
- •No skin condition preventing sponge bathing
- •No congenital or acquired hearing impairment
- •Newborns born by spontaneous vaginal delivery or cesarean section
排除标准
- •Use of sedative and/or muscle relaxant medications
- •Newborns receiving mechanical ventilation support
- •Diagnosis of asphyxia
- •Being within the first 72 hours of the postoperative period
- •Impaired skin integrity
- •Presence of cranial hemorrhage or major congenital, chromosomal, or neurological anomalies
研究组 & 干预措施
INTERVENTION GROUP
Newborns in this group receive sponge bathing while Brahms' lullaby is played during the bathing procedure in the neonatal intensive care unit.
干预措施: Brahms' Lullaby (Behavioral)
INTERVENTION GROUP
Newborns in this group receive sponge bathing while Brahms' lullaby is played during the bathing procedure in the neonatal intensive care unit.
干预措施: Routine Sponge Bath (Behavioral)
CONTROL GROUP
Newborns in this group receive routine sponge bathing without music in the neonatal intensive care unit.
干预措施: Routine Sponge Bath (Behavioral)
结局指标
主要结局
Neonatal Comfort (COMFORTneo Scale Score)
时间窗: Before bathing, immediately after bathing, and 15 minutes after bathing.
Neonatal comfort will be assessed using the COMFORTneo Scale before sponge bathing, immediately after bathing, and 15 minutes after bathing.
次要结局
未报告次要终点
研究者
Gamze Gocmen
Ebe
Ege University