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

NCT ID: NCT06959264

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-28

Study Completion Date

2025-12-15

Brief Summary

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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

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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.

Conditions

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Prostate Biopsy

Keywords

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Virtual Reality Anxiety Comfort Complication Nursing Prostate biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
During the data collection process, when the patients come to the urology outpatient clinic, their inclusion status will be evaluated by the researcher M.B. A total of 70 patients in the sample group determined by randomization will be divided into A and B groups created by the same statistician in the computer environment by block randomization (1:1 ratio) method according to the order of arrival. The A and B status of the study or control group will be determined by coin toss at the beginning of the study. The information showing that the patients included in the research sample are assigned to group A and B according to the randomization table will be placed in an opaque envelope. This envelope will be kept by the researcher (GAU) and when the researchers (GB and EKD) go to the patient for the application, they will open the envelope after filling out the "Informed Consent Form" and learn which group the patient is in. While the researchers (GB and EKD) will be blinded in the assign

Study Groups

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Virtual reality group

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.

Group Type EXPERIMENTAL

Virtual reality

Intervention Type OTHER

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 urodynamic procedure.

Control group

The control group will not receive any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual reality

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 urodynamic procedure.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mersin University

OTHER

Sponsor Role collaborator

Tarsus University

OTHER

Sponsor Role lead

Responsible Party

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Gamze BOZKUL

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülay Altun Uğraş

Role: PRINCIPAL_INVESTIGATOR

Mersin University

MURAT Bozlu

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Locations

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Tarsus University

Mersin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 33457274 (View on PubMed)

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.

Reference Type RESULT
PMID: 35397973 (View on PubMed)

Other Identifiers

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TU-BOZKUL-012

Identifier Type: -

Identifier Source: org_study_id