The Effect of Non-invasive Bladder Stimulation Technique on Collecting Urine Specimen in Infants Under One Year Old

NCT05394454 | Unknown

• 1 other identifier: Barış090221
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary tract infection (UTI) is common in early childhood. The American Academy of Pediatrics accepts suprapubic aspiration and bladder catheterization as the gold standard for the diagnosis of UTI. However, these techniques are painful and invasive. Clean-caught urine provides an acceptable urine specimen for the diagnosis of UTI, although this method is possible for toilet-trained children. Bladder stimulation maneuvers that allow clean-caught urine specimens have recently been identified in children who are not toilet trained. This study was planned to examine the effect of non-invasive bladder stimulation technique used in collecting urine specimen in infants under the age of one, on the success of the procedure, the duration of the procedure, the physiological parameters of the baby, and the level of pain.

Conditions

Urine Specimen Collection

Keywords

urine specimen; infant; bladder stimulation; pain

Outcome Measures

Primary Outcomes (2)

• Procedural success

  Procedural success is defined as urine sample collection within 3 minutes (180 seconds) of starting the stimulation maneuvers.

  During the procedure (3 minutes)

• Duration of the procedure

  Duration of the procedure is defined as the time from the beginning of bladder stimulation to the beginning of micturition.

  During the procedure (3 minutes)

Secondary Outcomes (3)

• Pain severity

  Baseline (Before the procedure), at the 1st and 3rd minutes

• Heart rate

  Baseline (Before the procedure), at the 1st and 3rd minutes

• Peripheral oxygen saturation level

  Baseline (Before the procedure), at the 1st and 3rd minutes

Study Arms (2)

Experimental Group

EXPERIMENTAL

* Breast milk/formula milk/water intake appropriate for the infant's age and weight will be provided 20-30 minutes before collecting the urine sample. * Before the procedure, the infant's heart rate, saturation and Flacc scale score (by the researcher and the observer nurse) will be recorded. * Genital area will be cleaned. * Infants will be held under the armpit by a parent, baby boys will be held with their legs hanging down, and baby girls will be held in hip flexion position. * Infants with spontaneous voiding during the period from the beginning of the research procedure until the infant is positioned will be excluded from the study. * The bladder stimulation technique will be repeated sequentially for 3 minutes until micturition begins. * After the maneuvers are started, the infants's heart rate and saturation FLACC pain scale score will be recorded at the 1st and 3rd minutes. * The success of the procedure and the duration of the procedure will be recorded

Procedure: Bladder stimulation technique

Control Group

NO INTERVENTION

* Breast milk/formula milk/water intake appropriate for the infant's age and weight will be provided 20-30 minutes before collecting the urine sample. * Before the procedure, the infant's heart rate, saturation and Flacc scale score (by the researcher and the observer nurse) will be recorded. * Genital area will be cleaned. * Infants will be held under the armpit by a parent, baby boys will be held with their legs hanging down, and baby girls will be held in hip flexion position. * Infants with spontaneous voiding during the period from the beginning of the research procedure until the infant is positioned will be excluded from the study. * Bladder stimulation technique will not be applied. * Infants will be observed for 3 minutes. Infants's heart rate and saturation FLACC pain scale score will be recorded at the 1st and 3rd minutes. * The success of the procedure and the duration of the procedure will be recorded

Interventions

Bladder stimulation technique PROCEDURE

The bladder stimulation technique consists of two consecutive maneuvers. In the first maneuver, the bladder is stimulated by tapping the suprapubic region for 30 seconds at a frequency of 100 touches per minute. In the second maneuver, circular massage is applied to the paravertebral region for 30 seconds. The two stimulation maneuvers will be repeated alternately for 3 minutes (180 seconds) until micturition begins.

Experimental Group

Eligibility Criteria

• Age: 4 Weeks - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Collecting urine specimen
• Between 1-12 months
• Being fed orally
• Having written consent from parents
• Complete skin integrity in the area where the maneuver will be performed

You may not qualify if:

• Poor general clinical condition (respiratory distress, etc.)
• Having signs of dehydration
• Having a diagnosed chronic health problem
• Having neurological and anatomical anomalies that may affect bladder function
• Any condition (intussusception, appendicitis, etc.) that will prevent the implementation of the stimulation maneuver.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Nihan Korkmaz

Şişli, Istanbul, 34360, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Altuntas N, Tayfur AC, Kocak M, Razi HC, Akkurt S. Midstream clean-catch urine collection in newborns: a randomized controlled study. Eur J Pediatr. 2015 May;174(5):577-82. doi: 10.1007/s00431-014-2434-z. Epub 2014 Oct 17.

  PMID: 25319844 BACKGROUND

• Herreros Fernandez ML, Gonzalez Merino N, Tagarro Garcia A, Perez Seoane B, de la Serna Martinez M, Contreras Abad MT, Garcia-Pose A. A new technique for fast and safe collection of urine in newborns. Arch Dis Child. 2013 Jan;98(1):27-9. doi: 10.1136/archdischild-2012-301872. Epub 2012 Nov 21.

  PMID: 23172785 BACKGROUND

• Kaufman J. How to... collect urine samples from young children. Arch Dis Child Educ Pract Ed. 2020 Jun;105(3):164-171. doi: 10.1136/archdischild-2019-317237. Epub 2019 Aug 23.

  PMID: 31444213 BACKGROUND

• Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

  PMID: 9220806 BACKGROUND

• Morello W, La Scola C, Alberici I, Montini G. Acute pyelonephritis in children. Pediatr Nephrol. 2016 Aug;31(8):1253-65. doi: 10.1007/s00467-015-3168-5. Epub 2015 Aug 4.

  PMID: 26238274 BACKGROUND

• Tran A, Fortier C, Giovannini-Chami L, Demonchy D, Caci H, Desmontils J, Montaudie-Dumas I, Bensaid R, Haas H, Berard E. Evaluation of the Bladder Stimulation Technique to Collect Midstream Urine in Infants in a Pediatric Emergency Department. PLoS One. 2016 Mar 31;11(3):e0152598. doi: 10.1371/journal.pone.0152598. eCollection 2016.

  PMID: 27031953 BACKGROUND

• Şenaylı Y, Özkan F, Şenaylı A. Evaluation of postoperative pain in Turkish Translation. Turkish Clinics Journal of Anesthesiology Reanimation. 2006; 4(1): 1-4.

  BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Birsen Mutlu, Ph.d

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Sinem Oral Cebeci

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nihan Korkmaz, MSc.

CONTACT

+90 +90 212 404 0300; nihan.korkmaz@iuc.edu.tr

Birsen Mutlu, Ph.d

CONTACT

+90 212 404 0300; bdonmez@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: Randomized controlled experimental design

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: October 15, 2021
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

TU (1)