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临床试验/NCT07277894
NCT07277894尚未招募不适用

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

Saglik Bilimleri Universitesi0 个研究点目标入组 60 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Change in State Anxiety Score (State-Trait Anxiety Inventory - STAI-State)

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Change in State Anxiety Score (State-Trait Anxiety Inventory - STAI-State)

时间窗: Baseline and immediately after the procedure

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)

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra Özden

Principal Investigator and Lecturer

Saglik Bilimleri Universitesi

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