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NOT YET RECRUITING
NCT06691438
NA

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

Sponsor: University Hospital, Grenoble

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2024-12-01

Completion Date

2026-10-01

Last Updated

2024-11-15

Healthy Volunteers

No

Conditions

Interventions

DEVICE

prostate biopsy

prostate biopsies with virtual reality hypnosis headset

Locations (1)

University Hospital Grenoble

Grenoble, France