The Effect of Virtual Reality During Urodynamics on Vital Signs, Anxiety, and Satisfaction

Official title

The Effect of Virtual Reality During Non-Invasive Urodynamics on Patients' Vital Signs, Anxiety, and Satisfaction Levels

Overview

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.

Detailed description

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.

Interventions

• Other Virtual reality group
  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.

Primary outcome measures

• Change in State Anxiety Score (State-Trait Anxiety Inventory - STAI-State) [Time frame: Baseline and immediately after the procedure]

Secondary outcome measures (4)

• Uroflowmetry Parameters (Qmax, Qavg, voided volume, flow time) [Time frame: During the procedure]
• Change in Vital Signs (blood pressure, heart rate, respiratory rate, oxygen saturation) [Time frame: Baseline and immediately after procedure]
• Patient Satisfaction Score (Visual Analog Scale - VAS) [Time frame: Immediately after the procedure]
• Patient Comfort Score (Visual Analog Scale - VAS) [Time frame: Immediately after the procedure]

Eligibility criteria

Inclusion criteria

• Being the first to undergo noninvasive urodynamics;
• Agreeing to participate in the study;
• Being between the ages of 30-50.

Exclusion criteria

• Having had a urodynamic test before;
• Being on antidepressants or anxiolytics;
• Having communication and cooperation problems;
• Having visual or balance disorders.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07277894 · SagligBilimleriU

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗