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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urine Specimen Collection
• Intervention / Treatment: Other: Control; Other: The bladder stimulation technique; Other: Bath

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zeynep Erkut, PhD; Phone Number: +905353610075; Email: zeyneperkut@maltepe.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Maltepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Experimental: 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.	Other: 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.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success in Urination	Success in urination is defined as urine sample collection within 3 minutes (180 seconds)	During the procedure (3 minutes)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Maltepe University

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: urine; bath; bladder stimulation technique; term babies
• Other Study ID Numbers: 2023/01-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No