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

I

Istanbul Medeniyet University

Status

Completed

Conditions

Nursing Interventions
Urine
Infant

Treatments

Procedure: Subrapubic cutaneous stimulation
Procedure: Bladder stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT07075094
2025-01/77

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

1 to 6 months old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

72 participants in 3 patient groups

Control Group
No Intervention group
Description:
Urine samples from infants in the control group will be collected according to the clinic's routine practice. Unlike routine practice, these infants will be positioned to ensure similarity to the experimental groups. Urine samples will be collected in an upright position, held under the arms. No noninvasive stimulation will be used.
Bladder stimulation
Experimental group
Description:
These babies will be held in an upright position by holding them under their arms during the urine sample collection process. A bladder stimulation technique will be used during the procedure.
Treatment:
Procedure: Bladder stimulation
Subrapubic cutaneous stimulation
Experimental group
Description:
These babies will be held in an upright position by holding them under their arms during the urine sample collection process. A subrapubic cutaneous stimulation technique will be used during the procedure.
Treatment:
Procedure: Subrapubic cutaneous stimulation

Trial contacts and locations

1

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Central trial contact

Aynur Aytekin Özdemir, PhD

Data sourced from clinicaltrials.gov

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