Effect of Virtual Reality Goggles on Anxiety, Comfort and Complications in Patients Undergoing Transrectal Ultrasound-guided Prostate Biopsy

Phase

N/A

Condition

Anxiety Disorders

Panic Disorders

Prostate Disorders

Treatment

Virtual reality

Clinical Study ID

NCT06959264

TU-BOZKUL-012

Ages > 18
Male

Study Summary

This study was aimed to determine the effect of virtual reality goggles on anxiety, comfort and complication development in patients undergoing transrectal ultrasound-guided prostate biopsy in a randomized controlled experimental study. The study will be conducted with individuals who applied to the Department of Urology of Mersin University Hospital. The minimum sample calculation with 95% power was calculated as a total of 70, 35 in each group, in the G*Power (3.1) program. Introductory Information Form, State Anxiety Scale, Complication Follow-up Form and Visual Analog Scale will be used to collect the data. Introductory Information Form, State Anxiety Scale and Visual Analog Scale will be filled in the patients. 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 a video with virtual reality glasses during the procedure. Virtual reality goggles will be used to watch nature landscapes with relaxing music background, adjusted at the level of volume desired by the patient. Virtual reality goggles will be applied during the procedure. The control group will not receive any intervention. After the virtual reality application, anxiety levels and comfort levels will be re-evaluated after the procedure. The patients will be called by the researchers after 24 hours and the Complication Follow-up Form will be filled out. The data obtained in the study will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 25.0 program.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Who agreed to participate in the study,
Patients over 18 years of age
Conscious, oriented and cooperative,
No communication problems,
Transrectal ultrasound guided prostate biopsy procedure,
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

Exclusion Criteria:

Who did not agree to participate in the study,
Patients under 18 years of age,
Conscious, oriented and uncooperative,
Communication problems,
No transrectal ultrasound-guided prostate biopsy procedure,
With a physical problem that would prevent the application of virtual realitygoggles,
Diagnosed with anxiety,
Taking medication for anxiety (anxiolytics, antidepressants, antipsychotics,etc.),
Patients with mental disorders

Study Design

Virtual reality

April 28, 2025

December 15, 2025

Study Description

This study was aimed to determine the effect of virtual reality goggles on anxiety, comfort and complication development in patients undergoing transrectal ultrasound-guided prostate biopsy in a randomized controlled experimental study. The study will be conducted with individuals who applied to the Department of Urology of Mersin University Hospital between May 2025 and May 2026 and met the sampling criteria. Taking the effect size 0.87 as a reference, d=0.87, (1- α, bidirectional), the minimum sample calculation with 95% power was calculated as a total of 70, 35 in each group, in the G*Power (3.1) program. Introductory Information Form, State Anxiety Scale, Complication Follow-up Form and Visual Analog Scale will be used to collect the data. Introductory Information Form, State Anxiety Scale and Visual Analog Scale will be filled in the patients. 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 a video with virtual reality glasses during the procedure. Patients will be asked to wear a virtual reality goggles (VR Shinecon G12 3d Virtual Reality Goggles Black 4.5-7.0 Inch) compatible with a mobile phone (Xiaomi Redmi Note 8 Pro 2019 model) with android operating system and minimizing sound loss in the supine position.Virtual reality goggles will be used to watch nature landscapes with relaxing music background, adjusted at the level of volume desired by the patient. Virtual reality goggles will be applied during the procedure. The control group will not receive any intervention. After the virtual reality application, anxiety levels and comfort levels will be re-evaluated after the procedure. The patients will be called by the researchers after 24 hours and the Complication Follow-up Form will be filled out. The data obtained in the study will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 25.0 program.

Connect with a study center

Tarsus University
Mersin, 33400
Turkey
Site Not Available
Tarsus University
Mersin 304531, 33400
Turkey (Türkiye)
Site Not Available

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