CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Virtual reality gogglesother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06528925
NCT06528925N/ACompleted

Effect of Virtual Reality Goggles on Pain, Anxiety and Hemodynamic Variables During Urodynamics: A Randomized Controlled Study

Tarsus University·interventional·Posted Jul 30, 2024·Updated Jul 22, 2025

In Brief

A clinical study evaluating Virtual reality goggles for Virtual Goggles and 4 related conditions. Completed, enrolled 84 participants across 1 site.

Detailed Summary

The research was planned as a randomized controlled experimental study to determine the effect of virtual reality goggles on pain, anxiety and hemodynamic variables during urodynamics. The minimum sample size was calculated as 42 in each group with d=0.8, (1- α, bidirectional), 95% power with reference to the effect size limit of 0.8 in G\*Power (3.1) program. Descriptive Information Form, Visual Analog Scale, State Anxiety Scale and Hemodynamic Variables Monitoring Form will be used to collect research data. The individuals in the sample group will be informed about the method followed in the application and the research and their verbal and written permissions will be obtained. Introductory Information Form, Visual Analog Scale, State Anxiety Scale and Hemodynamic Variables Monitoring Form will be completed. After the forms are applied to the patients and recorded, it will be determined whether they will be in the study or control group according to the randomization schedule.Patients in the study group will be shown videos with virtual reality glasses during the procedure. Nature landscapes with relaxing music background will be watched with virtual reality goggles by adjusting the volume at the level desired by the patient. Virtual reality goggles will be applied during the urodynamic procedure. The control group will receive routine care. After the virtual reality application, pain, anxiety levels and hemodynamic variables will be re-evaluated immediately and 15 minutes after the procedure. The data obtained in the study will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 25.0 program. Descriptive statistical methods (number, percentage, min-max values, mean and standard deviation) will be used to evaluate the data. Parametric and nonparametric tests will be used according to the suitability of the data used for normal distribution. P \< 0.05 will be taken as statistically significant difference

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
CollaboratorsMersin University

Timeline

N/ACompletedFinished
20252026
First PostedJul 30, 2024
Enrollment StartAug 15, 2024
Primary CompletionJan 15, 2025
Study CompletionFeb 15, 2025
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 1.9 years ago

Interventions

Virtual reality gogglesother

Patients in the study group will be shown a video with virtual reality glasses during the procedure. Patients will be asked to wear a virtual reality goggle (VR Box Virtual Reality Headset 3D Vr Glasses V2.0 2020 model) that is compatible with a mobile phone (Xiaomi Redmi Note 8 Pro 2019 model) with android operating system and minimizes sound loss in the supine position. With the virtual reality glasses, nature landscapes with relaxing music background will be watched by adjusting the volume at the level desired by the patient. Virtual reality goggles will be applied during the urodynamic procedure.