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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2025-09-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Infant Urine Nursing Interventions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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).

Study Groups

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Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Bladder stimulation

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.

Group Type EXPERIMENTAL

Bladder stimulation

Intervention Type 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

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.

Group Type EXPERIMENTAL

Subrapubic cutaneous stimulation

Intervention Type PROCEDURE

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

Interventions

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Bladder stimulation

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.

Intervention Type PROCEDURE

Subrapubic cutaneous stimulation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No