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

Tarsus University

Status: Enrolling

Conditions: Prostate Biopsy

Treatments: Other: Virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT06959264

TU-BOZKUL-012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Virtual reality group

Experimental group

Description:

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 in supine position and minimizing sound loss. With the virtual reality goggles, nature landscapes with a 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 procedure.

Treatment:

Other: Virtual reality

Control group

No Intervention group

Description:

The control group will not receive any intervention.