Clinical trial NCT06959264: Effect of Virtual Reality Goggles on Anxiety, Comfort and Complications in Patients Undergoing Transrectal Ultrasound-guided Prostate Biopsy
Official title: Effect of Virtual Reality Goggles on Anxiety, Comfort and Complications in Patients Undergoing Transrectal Ultrasound-guided Prostate Biopsy: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Biopsy
Keywords: Virtual Reality
Anxiety
Comfort
Complication
Nursing
Prostate biopsy
Lead sponsor: Tarsus University
Sponsor class: OTHER
Collaborators: name: Mersin University
First posted: 2025-05-06
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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 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 reality goggles,
  * Diagnosed with anxiety,
  * Taking medication for anxiety (anxiolytics, antidepressants, antipsychotics, etc.),
  * Patients with mental disorders

Primary outcomes:
measure: Anxiety
timeFrame: 6 months
measure: Comfort
timeFrame: 6 months
measure: Complications
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Tarsus University
city: Mersin
country: Turkey
facility: Tarsus University
Study officials:
affiliation: Mersin University
name: Gülay Altun Uğraş
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: MURAT Bozlu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomson A, Li M, Grummet J, Sengupta S. Transperineal prostate biopsy: a review of technique. Transl Androl Urol. 2020 Dec;9(6):3009-3017. doi: 10.21037/tau.2019.12.40.
citation: Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.