Virtual Reality Group
OtherIn 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.
NCT Number: NCT07277894
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.
Trial opening soon.
Get Notified18 year–50 year
All sexes
Interventional
Not applicable
Background:
Urodynamic studies are essential diagnostic tools for evaluating lower urinary tract function. However, they often cause discomfort, pain, and anxiety, which may negatively affect patient experience and the accuracy of clinical results. Non-pharmacological interventions such as music therapy and aromatherapy have been shown to reduce anxiety. Virtual reality (VR) is a promising new approach that provides immersive distraction and has demonstrated benefits in clinical care, but its use in urodynamic testing remains limited.
Objective:
To evaluate the effects of VR application during non-invasive urodynamics on:
Vital signs
Anxiety
Comfort
Patient satisfaction
Design and Setting:
Single-center, randomized controlled clinical trial. Location: Urology Outpatient Clinic, Ankara Etlik City Hospital. Study period: November 2025 - January 2026.
Participants:
Minimum 52 participants (26 per group).
Inclusion criteria
Adults aged 18-50, undergoing non-invasive urodynamics for the first time, voluntary participation.
Exclusion criteria
Previous urodynamics, antidepressant/anxiolytic use, communication problems, visual or balance disorders.
Randomization:
Block randomization (block size = 6).
Interventions:
VR Group: During uroflowmetry, participants will use VR goggles displaying a 360° visualization of a hygienic and spacious bathroom environment.
Control Group: Routine clinical practice only, with standard pre-procedure information.
Measurements and 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
Data Collection and Analysis:
Assessments conducted before, during, and after urodynamics.
Statistical analyses with SPSS 21.0.
Normality tested with Kolmogorov-Smirnov.
Group comparisons with Independent Samples t-test or Mann-Whitney U test.
Significance level: p < 0.05.
Ethics:
Approved by the Gülhane Research Ethics Committee. Institutional approval obtained. Written informed consent will be collected from all participants.
Expected Contribution:
This trial will provide evidence on the role of VR in reducing anxiety, improving comfort, and enhancing patient satisfaction during urodynamic procedures.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In 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.
Time frame: Baseline and immediately after the procedure
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)
Time frame: During the procedure
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
Time frame: Baseline and immediately after procedure
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, %
Time frame: Immediately after the procedure
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)
Time frame: Immediately after the procedure
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)
Saglik Bilimleri Universitesi
Other
The Effect of Virtual Reality During Non-Invasive Urodynamics on Patients' Vital Signs, Anxiety, and Satisfaction Levels
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