Effects of Abdominal Massage Applied Once and Twice Daily in Phototherapy-Treated Term Newborns on Bilirubin Levels and Defecation: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- A transcutaneous bilirubin levels
研究概览
简要总结
Hyperbilirubinemia is a common condition in term newborns and is often treated with phototherapy. It is thought that abdominal massage may increase bowel movements, thereby increasing the frequency of defecation and supporting bilirubin excretion.
This randomized controlled trial aimed to evaluate the effect of abdominal massage, applied once or twice daily using the Vimala technique, on transcutaneous bilirubin levels and defecation frequency in hyperbilirubinemia-affected term newborns receiving phototherapy in the neonatal intensive care unit.
The study was conducted in the neonatal intensive care unit of a university hospital between February 29, 2020, and August 17, 2023. A total of 35 newborns meeting the inclusion criteria were randomly divided into three groups. Group Massage-1 received 10 minutes of abdominal massage once daily before feeding for three days (n=12). Group Massage-2 received massage twice daily for the same duration (n=10). The control group received routine care (n=13).
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
Newborns meeting the sampling criteria were assigned to experimental and control groups using a simple random number table. The study was single-blind because the researchers knew which group the newborns in the sample were in. However, the statistical analysis was double-blind because the statistics for the data were performed by a different person.
入排标准
- 年龄范围
- 2 Days 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term newborns (37-42 weeks gestation)
- •2-10 days postpartum
- •Diagnosed with hyperbilirubinemia
- •Receiving phototherapy
- •Fully orally fed.
排除标准
- •Newborns with ABO incompatibility or Rh incompatibility.
- •Diagnosed with direct hyperbilirubinemia.
- •Genetic/metabolic diseases
- •Infections within 24 hours
- •With a need for fluid replacement
- •Having skin anomalies
- •Having abdominal disorders and surgery.
研究组 & 干预措施
Massage-1 Group
Babies in Massage-1 received a 10-minute abdominal massage once a day before feeding for three days.
干预措施: Massage once a day for 3 days. (Other)
Massage-2 Group
Babies in the Massage-2 group received a 10-minute abdominal massage twice a day before feeding for three days.
干预措施: Massage twice a day for 3 days. (Other)
Control Group
结局指标
主要结局
A transcutaneous bilirubin levels
时间窗: 6 hours after phototherapy
Defecation
时间窗: Diapers were changed a total of 8 times a day. Defecation outcome was assessed in 24-hour intervals for 3 days.
次要结局
未报告次要终点