The Effect of Bladder Stimulation Technique and Bathing Method on Urine Collection in Term Babies

Urine Specimen Collection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06188078
• Other study ID #: 2023/01-04
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2024
• Source: Maltepe University
• Contact: Zeynep Erkut, PhD
• Phone: +905353610075
• Email: zeyneperkut[@]maltepe.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 20 minutes, a bladder 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 20 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 given a bath under running water for no longer than 5 minutes before feeding. After the bath, the baby will be fed, and a urine bag will be inserted 20 minutes after the feeding. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Urine Specimen Collection

Intervention

Other:
• Control
Babies in the control group will be fed only breast milk or formula, and a urine bag will be inserted after 10 minutes and they will be expected to urinate. The success of the transaction and the processing time will be recorded.
• The bladder stimulation technique
Newborns will be fed formula or pumped breast milk, depending on the baby's age and weight. A urine bag will be inserted 10 minutes after the feeding. The newborn will be held under the armpit by the nurse, male infants will be held with their legs hanging down, and female infants will be held in the hip flexion position. Newborns with spontaneous voiding during the period from the beginning of the investigation procedure to positioning the newborn will be excluded from the study. The bladder stimulation technique will be repeated sequentially for 3 minutes until voiding begins.The success of the transaction and the processing time will be recorded.
• Bath
Newborns will be fed formula or pumped breast milk, depending on the baby's age and weight. Babies in the bath group will be given a bath under running water for no longer than 5 minutes before feeding. After the bath, the baby will be fed, and a urine bag will be inserted 10 minutes after the feeding. The success of the transaction and the processing time will be recorded.

Locations

Country	Name	City	State
Turkey	Maltepe University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Maltepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success in Urination	Success in urination is defined as urine sample collection within 3 minutes (180 seconds)	During the procedure (3 minutes)
Primary	Total Urination Time	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.	During the procedure (3 minutes)
Secondary	Comfort Level	The comfort levels of the infants during the procedure will determined by the researcher who is a specialist in pediatric nursing by using the Newborn Comfort Behavior Scale (COMFORTneo).	Baseline (Before the procedure), at the 1st and 2nd minutes