Evaluation of the Effect on Pain of Attentional Diversion Associated with Hypnotic Induction by Virtual Reality (VRH) in Perioperative Prostate Biopsies Under Local Anesthesia:
- Conditions
- Prostate Biopsy
- Registration Number
- NCT06691438
- Lead Sponsor
- University Hospital, Grenoble
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 130
- Adult patients who are candidates for ultrasound-guided prostate biopsies under local anesthesia, via transperineal or transrectal route
- Patient having signed informed consent
- 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
- Claustrophobic patients or those who cannot tolerate a mask over their eyes
- Refusal of local anesthesia
- Protected person (art. L1121-5 to L1121-8 of the CSP)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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. after the procedure 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 Outcome Measures
Name Time Method Pain upon returning home the same evening and on D1 after procedure, at 1 day after procedure Numerical pain scale 0-10 on returning home the same evening and on D1 collected in the patient notebook
Adverse effects related to the procedure during one month at 1 month Patient notebook for collecting adverse effects for 1 month
Qualitative assessment of the patient's experience after the procedure Semi-directed interview directly after the procedure
Length of stay in hospital / outpatient care at 1 month Length of stay in day hospital or outpatient care, in minutes (Time leaving the room - Time entering the room)
Success of biopsies at 1 month Number of biopsies performed/planned (ratio), achievement of the MRI target (Yes/no)
Need for general anesthesia after the procedure Rate of need for general anesthesia (in %)
Pain after the procedure when leaving the hospital Numerical scale 0-10 of pain upon discharge from the hospital
Stress during the procedure after the procedure Numerical stress scale from 0 to 10 upon arrival of the patient, and 15 minutes after the procedure
Immersion during hypnosis at the procedure Immersion scale from 0 to 10 during hypnosis
Evaluation of the nociceptive response to painful stimuli during the procedure Heart rate variability (= HRV) on the ECG trace (in milliseconds)
Satisfaction with the procedure after the procedure Desire to repeat this method of anesthesia in the event of an iterative procedure versus general anesthesia (yes/no)
Duration of the procedure after the procedure Duration of the procedure in minutes (time between the start of the procedure and the end of the procedure by the surgeon)
Trial Locations
- Locations (1)
University Hospital Grenoble
🇫🇷Grenoble, France