Effects of Massage, Tub Bathing, and Sponge Bathing on Bilirubin Levels, Skin Barrier, Neonatal Comfort, and Vital Signs: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Serum Bilirubin Levels
研究概览
简要总结
This randomized controlled trial evaluates the effects of massage, tub bathing, and sponge bathing on bilirubin levels, skin integrity, neonatal comfort, and physiological parameters in term newborns undergoing phototherapy
详细描述
Term newborns undergoing phototherapy in the neonatal intensive care unit will be randomized into four groups: massage, sponge bath, tub bath, and control. Pre-intervention assessments include vital signs, skin moisture, bilirubin levels, the Neonatal Comfort Behavior Scale, and the Skin Condition Assessment Scale. Post-intervention assessments are conducted at multiple time points. The study investigates whether massage and bathing interventions can improve comfort, maintain skin integrity, and reduce bilirubin levels more effectively than standard care.
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
盲法说明
The study is open-label due to the nature of the interventions, which cannot be blinded.
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion newborns (>37 weeks gestation)
- •Receiving phototherapy
- •Stable vital signs
- •Parental consent
排除标准
- •Congenital anomalies
- •Severe infections or sepsis
- •Parental refusal
结局指标
主要结局
Change in Serum Bilirubin Levels
时间窗: Baseline, 6 hours, 24 hours after intervention
Measured in mg/dL using standard laboratory testing
次要结局
未报告次要终点
研究者
Rukiye Öztürk
REGİSTERED NURSE
Uludag University