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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
prostate biopsy
Deviceprostate biopsies with virtual reality hypnosis headset
Treatment groups
Trial outcomes
Primary outcomes
To prospectively compare perioperative pain assessed in patients undergoing targeted prostate biopsies, transrectally or transperineally, under local anesthesia with or without a virtual reality hypnosis headset.
maximum pain felt during the procedure on a numerical EN scale, ranging from 0 (no pain) to 10 (extreme pain). The values will be collected directly at the end of the procedure.
Secondary outcomes
Pain after the procedure
Numerical scale 0-10 of pain upon discharge from the hospital
Stress during the procedure
Numerical stress scale from 0 to 10 upon arrival of the patient, and 15 minutes after the procedure
Immersion during hypnosis
Immersion scale from 0 to 10 during hypnosis
Evaluation of the nociceptive response to painful stimuli
Heart rate variability (= HRV) on the ECG trace (in milliseconds)
Sponsors and contacts
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