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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Biopsy
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
EssaiClinique_HYPNOSURG-VR
Professeur
University Hospital, Grenoble
Eligibility Criteria
Inclusion Criteria
- •Adult patients who are candidates for ultrasound-guided prostate biopsies under local anesthesia, via transperineal or transrectal route
- •Patient having signed informed consent
Exclusion Criteria
- •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)
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.
Time Frame: 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 Outcomes
- Pain after the procedure(when leaving the hospital)
- Stress during the procedure(after the procedure)
- Immersion during hypnosis(at the procedure)
- Evaluation of the nociceptive response to painful stimuli(during the procedure)
- Satisfaction with the procedure(after the procedure)
- Duration of the procedure(after the procedure)
- Length of stay in hospital / outpatient care(at 1 month)
- Success of biopsies(at 1 month)
- Need for general anesthesia(after the procedure)
- Pain upon returning home the same evening and on D1(after procedure, at 1 day after procedure)
- Adverse effects related to the procedure during one month(at 1 month)
- Qualitative assessment of the patient's experience(after the procedure)