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Completed

NCT Number: NCT07075094

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

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.

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Key information

Age range

1 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medeniyet University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bladder stimulation

Procedure

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.

Subrapubic cutaneous stimulation

Procedure

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

Primary outcomes

  1. Procedural pain score- FLACC Pain Scale

    Time frame: 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.

  2. Urine sample collection success

    Time frame: 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 outcomes

  1. Procedure time

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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