CompletedNot Applicable

Effect of Virtual Reality Goggles on Pain, Anxiety and Hemodynamic Variables During Urodynamics

Turkey (Türkiye)84 participantsStarted 2024-08-15

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Who agreed to participate in the study, * between the ages of 18-65 * Conscious, oriented and cooperative, * No communication problems, * undergoing invasive urodynamics, * No physical problems that would prevent the application of virtual reality goggles, * No previous experience with virtual reality glasses, * Undiagnosed anxiety, * No medication for anxiety * Patients without mental disorders Exclusion Criteria: * Who did not agree to participate in the study, * Under 18 or over 65 years of age, * Conscious, oriented and uncooperative, * Communication problems, * No invasive urodynamics procedure, * Physical problem that would prevent the application of virtual reality goggles, * Diagnosed with anxiety, * Taking medication for anxiety (anxiolytics, antidepressants, antipsychotics, etc.), * Patients with mental disorders

What they're measuring

Pain score

Timeframe: 7 months

Anxiety

Timeframe: 7 months

Hemodynamic Variables

Timeframe: 7 months

Trial details

NCT IDNCT06528925

SponsorTarsus University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-15

View on ClinicalTrials.gov More Virtual Goggles trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.