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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Hospital, Grenoble

About this trial

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.

Eligibility criteria

Qualifiers

Adult patients who are candidates for ultrasound-guided prostate biopsies under local anesthesia, via transperineal or transrectal route

Patient having signed informed consent

Disqualifiers

Patient suffering from blindness or any other visual handicap that contraindicates the use of the headset

Deaf or hard of hearing patients

Patients suffering from epilepsy and/or mental deficiency, and/or disorders of higher functions

Psychotic patients

Trial design

Treatments tested in this trial

  • prostate biopsy

Treatment groups

130 Participants
are divided into 2 treatment groups

Sponsors and collaborators