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

Sponsor
Saglik Bilimleri Universitesi
Study ID
NCT07277894
Status
Not Yet Recruiting

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Conditions

  • Urinary Incontinence
  • Urodynamic Studies
  • Urodynamics

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Virtual reality group — 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.

Study Details

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.

Key Dates

First listed
Dec 11, 2025
Start date
Dec 1, 2025
Status verified
Nov 2025
Primary completion
Jan 15, 2026
Completion
Jan 15, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • No Intervention: Control group
    The control group participants will not be equipped with virtual reality headsets, and only routine clinical procedures will be administered.

Primary Outcome Measure

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

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