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

NCT07277894 | Not Yet Recruiting

• 1 other identifier: SagligBilimleriU
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urodynamics; Urinary Incontinence; Urodynamic Studies

Keywords

Urinary incontinence; urodynamic studies; anxiety; satisfaction

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline and immediately after the procedure

Secondary Outcomes (4)

• Uroflowmetry Parameters (Qmax, Qavg, voided volume, flow time)

  During the procedure

• Change in Vital Signs (blood pressure, heart rate, respiratory rate, oxygen saturation)

  Baseline and immediately after procedure

• Patient Satisfaction Score (Visual Analog Scale - VAS)

  Immediately after the procedure

• Patient Comfort Score (Visual Analog Scale - VAS)

  Immediately after the procedure

Study Arms (2)

virtual reality group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

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.

virtual reality group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

MeSH Terms

Conditions

Urinary Incontinence; Anxiety Disorders; Personal Satisfaction

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Lecturer

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: December 11, 2025
• Study Start: December 1, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available beginning 6 months after publication of the primary study results and will remain accessible for up to 5 years.
• Access Criteria: Access will be provided to qualified researchers who submit a methodologically sound proposal and obtain approval from an independent ethics committee. Requests should be directed to the Principal Investigator via institutional email.