The Effect of Bladder Stimulation Technique on Urine Specimen Collection in Newborns
Condition: Urine Specimen Collection
Study type: Interventional

Summary: 
      Urine specimen are necessary to diagnose various diseases in infants, especially urinary
      tract infections (UTI). Various non-invasive and invasive clinical interventions have been
      described for urine specimen collection. These; suprapubic aspiration, urinary
      catheterization, sterile urine collection bag and clean-caught urine (Herreros Fernández et
      al., 2013). For the diagnosis of UTI, it is recommended to collect urine samples by
      suprapubic aspiration (SPA) and urinary catheterization methods. However, these techniques
      are invasive and painful (Roberts et al. 2016). Clean-caught urine provides an acceptable
      urine sample for the diagnosis of UTI. But this method is possible for children with
      sphincter control. A technique was recently described that allows midstream urine specimen
      collection in children without sphincter control. This technique consists of bladder
      stimulation and lumbar paravertebral massage. The aim of this study is to evaluate the effect
      of bladder stimulation technique on procedural success, procedure time, physiological
      parameters and comfort in urine specimen collection in newborns.
    

Detailed description: 
      Urinary Tract Infection (UTI) is common in early childhood. Urinary Tract Infection (UTI) is
      the most common bacterial infection in febrile children younger than 3 months of age (Korbel
      et al., 2017; Velasco et al., 2015). A clean urine sample is required to diagnose various
      diseases, especially urinary tract infections (UTI) in infants. Various non-invasive and
      invasive clinical interventions have been described for urine specimen collection. These;
      suprapubic aspiration, urinary catheterization, sterile urine collection bag, and
      clean-caught urine (Herreros Fernández et al., 2013).

      One of the non-invasive methods used to collect urine samples is the use of sterile urine
      collection bags (Herreros Fernández et al., 2013). This method is not an effective method due
      to its high false positive rate, time consuming, delayed treatment, skin irritation and high
      risk of contamination (Finnell et al., 2011; Kaufman et al., 2020). Therefore, sterile urine
      bags should be used in urinalysis instead of urine culture (Balighian & Review, 2018).
      Clean-caught urine provides an acceptable urine sample for the diagnosis of UTI. However,
      this method is possible for children with sphincter control (Altuntas et al., 2015; Kaufman
      et al., 2019).

      A technique was recently described that allows midstream urine specimen collection in
      children without sphincter control. The technique, consisting of bladder stimulation and
      lumbar paravertebral massage, was successful in 86% of newborns, with an average duration of
      57 seconds (Herreros Fernández et al., 2013). Previous studies have evaluated the technique's
      success rate and processing time (Altuntas et al., 2015, Labrosse et al., 2016, Crombie et
      al., 2020), contamination rate (Herreros et al., 2021), and cost (Kaufman et al., 2020)
      examined. Examination of the effect of the technique on the comfort and physiological
      parameters of the newborn will contribute to more information about the technique.

      The aim of this study is to evaluate the effect of bladder stimulation technique on
      procedural success, procedure time, physiological parameters and comfort in urine specimen
      collection in newborns.

      Study Population and Sampling The population of the research will be the newborns followed in
      the neonatal intensive care unit. The sample will consist of 64 (Experimental group = 32,
      Control group = 32) newborns who meet the inclusion criteria of the study. In calculating the
      sample size, Altuntaş et al. (2015) benefited from the study. Considering the success rates;
      The minimum number of samples to be taken was determined as 64 (Experimental group=32,
      Control group=32) with 95% confidence (1-α), 95% test power (1-β), w=0.453 effect size.

      Randomization Infants meeting the research inclusion criteria will be divided into
      experimental and control groups using a computer-based program (https://www.randomizer.org).

      Data Collection Method: The data will be collected by the a researcher in the unit where the
      study is planned to be carried out.

        -  Data Collection Form: Prepared by the researcher. The form includes questions about the
           infant's age, weight, gender, fever, heartbeat, saturation level, Comfortneo scale
           score, and procedure success and duration of the procedure.

        -  Comfortneo scale: Developed by Ambuel et al. (Ambuel et.al. 1992). Van Dijk et al.
           revised the COMFORTneo scale to measure behavior in newborns without physiological
           parameters (Van Dijk et. al. 2009). Turkish validity and reliability of the scale
           Kahraman et al. (Kahraman et. al 2014). The scale consists of 7 items: muscle tone,
           alertness, facial tension, calmness/agitation, body movements, respiratory response, and
           crying. "Respiratory response" is scored in infants on mechanical ventilator, and
           "crying" is scored in spontaneously breathing infants. A total score is calculated over
           6 items. The lowest score that can be obtained from this scale is 6, and the highest
           score is 30. A high score indicates that the baby is not comfortable and needs
           interventions to provide comfort (Kahraman et. al 2014).

        -  Pulse Oximeter Device to detect infants' oxygen saturation (SPO2) and heart rate (HR)

        -  Weighing Tool to determine the current weight of babies.

        -  Thermometer to determine babies' body temperature
    

Intervention name(s): The bladder stimulation technique; Steril urine bag
Intervention type(s): Procedure; Procedure
Intervention description(s): 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. Maneuvers will be performed by the researcher. Infants in both groups will be held under the armpit by a parent, male infants will be held in the drooping legs, and female infants will be held in the hip flexion position.; Steril urine bag are attached to the genital area to collect urine samples
Other intervention name(s): Sterile urine bag
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled experimental design
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: urine specimen; bladder stimulation technique; newborn; comfort; physiological parameters