About this trial
Study Topic
This research aims to evaluate the effects of virtual reality (VR) application during noninvasive urodynamics on patients' vital signs, anxiety, and satisfaction levels.
Significance of the Problem
Urodynamic studies are essential diagnostic methods for assessing lower urinary tract functions.
However, they often cause discomfort, pain, and high levels of anxiety in patients.
This not only negatively affects the patient experience but also creates uncertainty in clinical decision-making.
Previous studies have shown that nursing interventions such as music therapy, aromatherapy, and heating pads effectively reduce anxiety.
Recently, VR technology has emerged as a promising tool to distract patients, thereby reducing pain and anxiety.
Aim of the Study
To investigate the effects of VR application during noninvasive urodynamics on:
Vital signs,
Anxiety,
Comfort, and
Patient satisfaction.
Methodology
Design: Single-center, randomized controlled clinical trial.
Setting/Duration: Urology Outpatient Clinic, Ankara Etlik City Hospital, September - December 2025.
Sample: Based on power analysis, at least 26 patients per group; total minimum of 52 participants.
Inclusion criteria: 18-50 years old, undergoing noninvasive urodynamics for the first time, voluntary participation.
Exclusion criteria: Previous urodynamics, use of anxiolytics/antidepressants, communication/vision/balance impairments.
Randomization: Block randomization (block size 6).
Data Collection Tools
Descriptive Characteristics Form
State-Trait Anxiety Inventory (STAI)
Vital Signs and Urodynamic Parameters Monitoring Form
Patient Satisfaction and Comfort Assessment (Visual Analog Scale - VAS)
VR Application Satisfaction Form
Interventions
VR Group: During uroflowmetry, patients will experience a 360° virtual hygienic and spacious bathroom environment via VR goggles.
Control Group: Routine clinical practice only, with standard pre-procedure information.
Data Analysis
Data will be analyzed using SPSS 21.0.
Normality will be tested with Kolmogorov-Smirnov.
Between-group differences will be assessed using Independent Samples t-test or Mann-Whitney U test, as appropriate.
Statistical significance will be set at p \< 0.05.
Ethical Considerations
Ethical approval and hospital permission were obtained.
Informed consent will be collected from all participants prior to data collection.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being the first to undergo noninvasive urodynamics;
Agreeing to participate in the study;
Being between the ages of 30-50.
Disqualifiers
Having had a urodynamic test before;
Being on antidepressants or anxiolytics;
Having communication and cooperation problems;
Having visual or balance disorders.
Trial design
Parallel
Treatments tested in this trial
Virtual reality group
Other interventionIn the course of noninvasive urodynamic testing, patients will be presented with a 360-degree visualization of a clean and spacious bathroom environment via virtual reality goggles.
Treatment groups
Trial outcomes
Primary outcomes
Change in State Anxiety Score (State-Trait Anxiety Inventory - STAI-State)
State Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI-State), a 20-item scale ranging from 20 to 80 points. Higher scores indicate higher anxiety. Unit of Measure: points (20-80)
Secondary outcomes
Uroflowmetry Parameters (Qmax, Qavg, voided volume, flow time)
Uroflowmetry parameters including maximum flow rate (Qmax, mL/s), average flow rate (Qavg, mL/s), voided volume (mL), and flow time (seconds) will be recorded during the procedure. Unit of Measure: mL/s; mL; seconds
Change in Vital Signs (blood pressure, heart rate, respiratory rate, oxygen saturation)
Vital signs (systolic/diastolic blood pressure in mmHg, heart rate in bpm, respiratory rate in breaths/min, and SpO₂ in %) will be measured before and after the uroflowmetry procedure. Unit of Measure: mmHg, bpm, breaths/min, %
Patient Satisfaction Score (Visual Analog Scale - VAS)
Satisfaction will be assessed using a Visual Analog Scale ranging from 0 (no satisfaction) to 10 (highest satisfaction). Unit of Measure: VAS score (0-10)
Patient Comfort Score (Visual Analog Scale - VAS)
Comfort will be assessed using a Visual Analog Scale ranging from 0 (no comfort) to 10 (highest comfort). Unit of Measure: VAS score (0-10)
Locations
Sponsors and contacts
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