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

NCT07277894 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-11

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Saglik Bilimleri Universitesi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-01-15
Completion
2026-01-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07277894 on ClinicalTrials.gov