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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
130
prostate biopsies with virtual reality hypnosis headset
University Hospital Grenoble
Grenoble, France
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.
Time frame: after the procedure
Pain after the procedure
Numerical scale 0-10 of pain upon discharge from the hospital
Time frame: when leaving the hospital
Stress during the procedure
Numerical stress scale from 0 to 10 upon arrival of the patient, and 15 minutes after the procedure
Time frame: after the procedure
Immersion during hypnosis
Immersion scale from 0 to 10 during hypnosis
Time frame: at the procedure
Evaluation of the nociceptive response to painful stimuli
Heart rate variability (= HRV) on the ECG trace (in milliseconds)
Time frame: during the procedure
Satisfaction with the procedure
Desire to repeat this method of anesthesia in the event of an iterative procedure versus general anesthesia (yes/no)
Time frame: after the procedure
Duration of the procedure
Duration of the procedure in minutes (time between the start of the procedure and the end of the procedure by the surgeon)
Time frame: after the procedure
Length of stay in hospital / outpatient care
Length of stay in day hospital or outpatient care, in minutes (Time leaving the room - Time entering the room)
Time frame: at 1 month
Success of biopsies
Number of biopsies performed/planned (ratio), achievement of the MRI target (Yes/no)
Time frame: at 1 month
Need for general anesthesia
Rate of need for general anesthesia (in %)
Time frame: after the procedure
Pain upon returning home the same evening and on D1
Numerical pain scale 0-10 on returning home the same evening and on D1 collected in the patient notebook
Time frame: after procedure, at 1 day after procedure
Adverse effects related to the procedure during one month
Patient notebook for collecting adverse effects for 1 month
Time frame: at 1 month
Qualitative assessment of the patient's experience
Semi-directed interview directly after the procedure
Time frame: after the procedure
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