NCT06691438

Evaluation of the Effect on Pain of Attentional Diversion Associated with Hypnotic Induction by Virtual Reality (VRH) in Perioperative Prostate Biopsies Under Local Anesthesia:

Evaluation of the Effect on Pain of Attentional Diversion Associated with Hypnotic Induction by Virtual Reality (VRH) in Perioperative Prostate Biopsies Under Local Anesthesia: Prospective Randomized and Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to prospectively compare perioperative pain assessed in patients undergoing targeted prostate biopsies, either transrectally or transperineally, under local anesthesia with or without a virtual reality hypnosis headset. The study was sized based on a mean pain reduction of 1.5 points on a numerical scale (0-10 NAS), with an estimate of procedure-related pain of 4.0 on the NAS scale.

Detailed description

Prospective comparison of pain during the procedure assessed in patients treated for prostate biopsies under local anesthesia with or without a virtual reality headset.No additional examination will be performed in addition to the conventional management of a biopsy except for the fitting of the headset for patients randomized to the "with virtual reality headset" group. Patients will be randomized on the same day of the procedure into one of the two study groups. A single follow-up visit will be performed postoperatively 1 month after surgery.

Conditions

• Prostate Biopsy

Interventions

Type	Name	Description
DEVICE	prostate biopsy	prostate biopsies with virtual reality hypnosis headset

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-11-15
• Last updated: 2024-11-15

Locations

1 site across 1 country: France