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

NCT ID: NCT07277894

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-01-15

Brief Summary

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.

Conditions

Urinary Incontinence; Urodynamic Studies; Urodynamics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual reality group

Intervention Type: OTHER

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.

Control group

The control group participants will not be equipped with virtual reality headsets, and only routine clinical procedures will be administered.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Esra Özden

Principal Investigator and Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SagligBilimleriU

Identifier Type: -

Identifier Source: org_study_id