Clinical trial NCT06188078: The Effect of Bladder Stimulation Technique and Bathing Method on Urine Collection in Term Babies
Official title: The Effect of Bladder Stimulation Technique and Bathing Method on Urine Collection in Term Babies: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urine Specimen Collection
Keywords: term babies
urine
bladder stimulation technique
bath
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 102
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Success in Urination
timeFrame: During the procedure (3 minutes)
measure: Total Urination Time
timeFrame: During the procedure (3 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Maltepe University
Study officials:
References: