RecruitingACTRN12620000648921

Integration of Virtual Reality as analgesia for Trans-rectal Ultrasound prostate biopsy (TRUS): a randomized prospective study

Effect of Virtual Reality as analgesia for Trans-rectal Ultrasound prostate biopsy (TRUS) on pain severity: a randomized prospective study

Sponsor

University of Otago

Enrollment

250 participants

Start Date

Aug 1, 2020

Study Type

Interventional

Conditions

Peri- Procedural Pain

Summary

Aim: To determine if virtual reality technology will act as an analgesic aid to improve patient satisfaction during TRUS biopsy Hypothesis: If virtual reality technology is used at the time of routine TRUS biopsy procedures, there will be an improved patient levels of pain, anxiety and overall satisfaction. Brief Method: Men will be consented then randomly allocated to Virtual Reality (VR) intervention group or control group. Routine TRUS procedure under local anaesthetic will take place with no procedural change in the way samples are collected in both groups. However, the intervention group will wear a VR headset with distraction environment VR software. They will then watch a VR movie for the duration of the procedure. Prior to the procedure in each group, men will complete a standardized questionnaire about their expectations of the procedure. This will include questions relating to pain, anxiety and overall expectation. After the procedure, patients will complete the same questionnaire investigating their pain, anxiety, VR response (if applicable) and overall satisfaction.

Eligibility

Sex: MalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Prostate biopsy using transrectal ultrasound (TRUS) is a procedure used to investigate possible prostate cancer when a PSA blood test is elevated or a prostate examination feels abnormal. The biopsy involves taking small tissue samples through the rectum, which can cause significant pain and anxiety for many men, despite local anaesthetic being used. This study is testing whether wearing a virtual reality (VR) headset during the procedure — immersing the patient in a calming or distracting environment — can reduce pain, anxiety, and discomfort. Participants are randomly assigned to have the procedure with or without VR, and then asked to rate their experience. The procedure itself is carried out in exactly the same standard way in both groups; only the use of the VR headset differs. You may be eligible if you are a man attending for a TRUS biopsy to investigate a possible prostate cancer diagnosis, in line with standard New Zealand referral guidelines. Men with severe cognitive impairment or severe visual impairment are not eligible for this study.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

In an outpatient clinic the patient presenting for a TRUS biopsy will wear a Virtual Reality (VR) headset and watch a movie for the duration of the biopsy preocedure, duration estimated at 10-15minutes. The software for the movie will be a distraction application used on other similar studies. It will not require movement or active particpation in the VR environment, but merely passively watching the VR movie. The procedure will be carried out by a urology consultant or registrar with a urology nurse assisting. The biopsy procedure itself will not alter, it will be a standard ultrasound guided transrectal biopsy of the prostate and use local anesthetic.

Locations(1)

New Zealand

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ACTRN12620000648921