Effectiveness of Coconut Oil Massage Therapy on Bilirubin Levels, Growth, and Vital Stability among Neonates who are Undergoing Phototherapy: A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Massage therapy will result in a significant reduction in bilirubin levels and growth promotion.
研究概览
简要总结
Neonatal jaundice, caused by hyperbilirubinemia, is one of the most common conditions in newborns. Although phototherapy is the standard treatment, it may be associated with complications such as dehydration, electrolyte imbalance, and disruption of maternal–infant bonding. Complementary therapies such as massage may offer additional benefits by enhancing bilirubin elimination, promoting growth, and stabilizing vital functions.
This randomised controlled trial will evaluate the effectiveness of neonatal oil massage therapy in term neonates undergoing phototherapy at Sharda Hospital, Greater Noida. A total of 160 neonates diagnosed with physiological hyperbilirubinemia will be randomly assigned to either the intervention group (phototherapy plus oil massage) or the control group (phototherapy alone). The intervention involves standardized oil massage using warmed coconut oil for 10–15 minutes, three times daily, over a period of five days or until bilirubin normalization.
Primary outcome measures include changes in serum bilirubin levels, assessed at baseline and 24-hour intervals. Secondary outcomes include weight gain and vital stability parameters (heart rate, respiratory rate, temperature, and oxygen saturation), monitored throughout the intervention. Data will be analyzed using independent t-tests, repeated measures ANOVA, and chi-square tests, with significance set at p < 0.05.
It is anticipated that neonates receiving oil massage will demonstrate faster bilirubin reduction, improved growth, and greater physiological stability compared to those receiving phototherapy alone. Findings may provide evidence for integrating neonatal massage as a cost-effective, non-invasive complementary therapy in the management of neonatal jaundice.
The trial contains both the pilot and main study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Day(s) 至 7.00 Day(s)（—）
- 性别
- All
入选标准
- •Neonates aged 2 to 7 days Diagnosed with physiological hyperbilirubinemia Serum total bilirubin levels within phototherapy threshold, but below exchange transfusion threshold, based on AAP or IAP nomograms.
- •STB between 12 to 17 mg per dL Gestational age above 37 weeks Birth weight less than 1800 grams Stable clinical condition Parent or guardian Assent.
排除标准
- •Preterm infants Neonates with congenital anomalies or major structural malformations Direct (conjugated) hyperbilirubinemia: Direct bilirubin less than 20 percent of total or less than 2 mg per dL Serum bilirubin exceeding the exchange transfusion threshold Neonates requiring exchange transfusion.
结局指标
主要结局
Massage therapy will result in a significant reduction in bilirubin levels and growth promotion.
时间窗: 1 week.
More effective massage therapy will be developed against the existing phototherapy protocol.
时间窗: 1 week.
The findings could support the inclusion of massage as a complementary therapy in neonatal jaundice management protocols.
时间窗: 1 week.
次要结局
未报告次要终点
研究者
Nongmeikapam Helena
Sharda University