An interventional study of Virtual reality group in Urinary Incontinence, Urodynamic Studies and Urodynamics, sponsored by Saglik Bilimleri Universitesi. Not yet recruiting. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Supportive care
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.
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Saglik Bilimleri Universitesi is the lead sponsor of 430 studies on the registry; 137 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Other: Virtual reality group
The control group participants will not be equipped with virtual reality headsets, and only routine clinical procedures will be administered.
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.
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)
Time frame: Baseline and immediately after the procedure
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
Time frame: During the procedure
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, %
Time frame: Baseline and immediately after procedure
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)
Time frame: Immediately after the procedure
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)
Time frame: Immediately after the procedure
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data (IPD) related to primary and secondary outcomes will be shared. Supporting information including the study protocol, statistical analysis plan (SAP), informed consent form (ICF), and clinical study report (CSR) will also be made available.
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
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Saglik Bilimleri Universitesi