Determination of the Effectiveness of Two Different Noninvasive Stimulation Methods in Urine Collection in Infants

Not Applicable

Not yet recruiting

• Conditions: Infant; Urine; Nursing Interventions

• Registration Number: NCT07075094
• Lead Sponsor: Istanbul Medeniyet University

Brief Summary

This study will be conducted to determine the effects of bladder stimulation and subrapubic cutaneous stimulation techniques applied during urine sampling in infants on the success of urine sampling, pain and procedure time.

Detailed Description

Urinary tract infections are common in children. Urine samples and urinalysis are needed to confirm the diagnosis of urinary tract infection. Various invasive and noninvasive techniques are used for urine sample collection in children. These techniques include suprapubic aspiration, urinary catheterization, a sterile urine bag, and clean catch techniques. The clean catch technique is a commonly used noninvasive technique for urine sample collection in children. Parents have described clean catch urine collection in children who are not toilet-trained as time-consuming and complex. Alternative techniques that stimulate voiding in children who are not toilet-trained, allowing for quicker collection of urine samples using clean catch techniques, are beneficial. The noninvasive stimulation methods whose effectiveness in infant urine collection will be evaluated in this study are bladder stimulation and suprapubic cutaneous stimulation.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-11
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study Start: 2025-07-15
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• A urine sample must be collected due to suspicion of a urinary tract infection,
• The infant must be being fed orally,
• The skin in the area where the maneuver will be performed must be intact,
• The infant must be conscious and have stable vital signs.
• The infant must be from families that can speak and understand Turkish and are willing to participate in the study

Exclusion Criteria

• Presence of respiratory distress and signs of dehydration,
• Presence of a diagnosed chronic health problem,
• Presence of a neurological or anatomical abnormality that may affect bladder function,
• Presence of any diagnostic suspicion (distension, intussusception, appendicitis, etc.) that would preclude the application of the stimulation maneuver,
• Presence of cold stress.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Procedural pain score- FLACC Pain Scale	At the beginning of the procedure, at the end of the procedure	The Face, Legs, Activity, Cry, and Consolability (FLACC) scale consists of five categories (face, legs, activity, crying, and consolability), and each category is scored between 0 and 2 depending on the pain or distress behaviors observed. The total score ranges from 0 to 10, with 0 indicating no pain or distress and 10 indicating extreme pain or distress. The FLACC scale was developed to assess pain in children aged 2 months to 7 years and is one of the widely recommended scales for assessing pain and distress among pediatric patients.
Urine sample collection success	During the procedure (Average 5 minutes)	Infants who can have a urine sample collected during the procedure will be recorded as having a successful procedure.

Secondary Outcome Measures

Name	Time	Method
Procedure time	Through the procedure completion, an average of 5 minutes.	Procedure time is the time between the start of the stimulation method and the start of micturition.

Trial Locations

Locations (1)

Istanbul Medeniyet University; 🇹🇷 Istanbul, Turkey