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

Determination of the Effectiveness of Two Different Noninvasive Stimulation Methods in Urine Collection in Infants: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07075094
Enrollment
72
Registered
2025-07-20
Start date
2025-07-15
Completion date
2025-09-15
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Nursing Interventions, Urine

Keywords

Infant, Urine collection, Noninvasive stimulation

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.

Interventions

This stimulation consists of two stages. In the first maneuver, the bladder is stimulated by gentle tapping of the suprapubic area for 30 seconds. In the second maneuver, the paravertebral area is massaged in a circular motion for 30 seconds. The two stimulation maneuvers are repeated sequentially for 5 minutes.

PROCEDURESubrapubic cutaneous stimulation

Circular rubbing movements will be made on the baby's suprapubic area with gauze soaked in cold salt water until micturition begins.

Sponsors

Istanbul Medeniyet University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Using the block randomization technique, participants will be divided into 3 groups. A web-based randomization list creation tool will be used to create the blocked randomization list. Control and intervention groups will be coded as A, B and C using the sealed envelope method. Randomization information will be kept from the researcher involved in data collection until data collection begins. The researcher will learn which group each child is in just before the application (researcher blinding).Research data will be entered into the computer database by coding the group name as A, B and C, and statistical analysis will be performed using this coding (statistician blinding).

Intervention model description

Participants will be assigned to experimental and control groups using block randomization method. Age and sex variables will be used for block randomization. In order to reach the sample size calculated in the study, strata will be repeated two times (2X2X6) and 24 infant will be included in each group.

Eligibility

Sex/Gender
ALL
Age
1 Months to 6 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Procedural pain score- FLACC Pain ScaleAt the beginning of the procedure, at the end of the procedureThe 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 successDuring 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

MeasureTime frameDescription
Procedure timeThrough 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026