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

NCT07075094 | Completed

• 1 other identifier: 2025-01/77
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant; Urine; Nursing Interventions

Keywords

Infant; Urine collection; Noninvasive stimulation

Outcome Measures

Primary Outcomes (2)

• Procedural pain score- FLACC Pain Scale

  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.

  At the beginning of the procedure, at the end of the procedure

• Urine sample collection success

  Infants who can have a urine sample collected during the procedure will be recorded as having a successful procedure.

  During the procedure (Average 5 minutes)

Secondary Outcomes (1)

• Procedure time

  Through the procedure completion, an average of 5 minutes.

Study Arms (3)

Control Group

NO INTERVENTION

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

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.

Procedure: Bladder stimulation

Subrapubic cutaneous stimulation

EXPERIMENTAL

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.

Procedure: Subrapubic cutaneous stimulation

Interventions

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.

Bladder stimulation

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.

Subrapubic cutaneous stimulation

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• Marchal S, Janicot J, Salicis J, Demonchy D, Herisse AL, Olla M, Rancurel A, Haas H, Berard E, Breaud J, Bernardor J, Ribet C, Freyssinet E, Donzeau D, Desmontils J, Schori-Fortier C, Fontas E, Tran A. Quick-Wee versus bladder stimulation to collect midstream urine from precontinent infants under 1 year of age: a study protocol for a randomised controlled trial (ES.Stimquick.U). BMJ Open. 2021 Sep 16;11(9):e046324. doi: 10.1136/bmjopen-2020-046324.

  PMID: 34531206 BACKGROUND

• Korkmaz N, Narter FK, Mutlu B, Sahin K, Ozgoru H. Effects of the bladder stimulation technique on urine sample collection in newborns: A randomized controlled study. Int J Nurs Pract. 2024 Oct;30(5):e13255. doi: 10.1111/ijn.13255. Epub 2024 Apr 15.

  PMID: 38622105 BACKGROUND

Study Officials

• Aynur Aytekin Ozdemir, Professor

  İstanbul Medeniyet University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 20, 2025
• Study Start: July 15, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: January through March of 2027
• Access Criteria: Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.

Locations

TU (1)