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临床试验/NCT06188078
NCT06188078已完成不适用

The Effect of Bladder Stimulation Technique and Bathing Method on Urine Collection in Term Babies: A Randomized Controlled Trial

Maltepe University2 个研究点 分布在 2 个国家目标入组 102 人开始时间: 2024年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
2
主要终点
Success in Urination

研究概览

简要总结

Purpose of the Study: The aim of this study is to examine the effect of bladder stimulation technique and bathing method on urine collection in term infants hospitalized in the neonatal intensive care unit.

Content of the Study: This study will consist of 3 groups. Babies in the 1st group, the control group, will be fed only with breast milk or formula, and after 25 minutes, a urine bag will be inserted and urination will be expected. The babies in the second group, the bladder stimulation technique application group, will also be placed in a urine bag 25 minutes after feeding. Then the bladder stimulation technique will be applied. This technique; consists of two consecutive maneuvers. In the first maneuver, the bladder (Urine Bag) is stimulated by hitting the suprapubic (lower parts of the abdomen) area for 30 seconds at a frequency of 100 touches per minute. In the second maneuver, a 30-second circular massage is applied to the paravertebral region (located next to the spine). Babies in the 3rd group, the bathing group will be fed formula or pumped breast milk, depending on the baby's age and weight. Babies will be bathed under running water 20 minutes after feeding.The bathing process will take 4 minutes in total. After bath, a urine bag will be inserted at the 25th minute of feeding. In all group, urine urination will be monitored by running the stopwatch immediately after the urine bag is placed on all babies. When the baby urinates, the stopwatch will be stopped and the time and success of urination will be recorded on the observation form by the researcher.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Term babies whose gestational age is 37+6 days and above,
  • Full-term newborns aged 1-28 days
  • Orally fed babies
  • Babies with stable health status,
  • Babies who do not have urological, neurological diseases, or anatomical anomalies that may affect bladder function,
  • Babies of parents who voluntarily agree to participate in the study will be included in the study.

排除标准

  • Preterm babies whose gestational age is below 37+6 days,
  • Babies fed with an orogastric tube (OGS),
  • Babies with serious health problems (such as respiratory distress),
  • Babies with urological, neurological diseases or anatomical anomalies that may affect bladder function,
  • Babies of parents who do not agree to participate in the study will be excluded from the study.

结局指标

主要结局

Success in Urination

时间窗: During the procedure (3 minutes)

Success in urination is defined as urine sample collection within 3 minutes (180 seconds)

Total Urination Time

时间窗: During the procedure (3 minutes)

Total urination time is defined as the time elapsed from the urine collection collector bag placed on the baby to the beginning of the micturition.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeynep Erkut

Assistant Professor, PhD

Maltepe University

研究点 (2)

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