Prostate Biopsy
Conditions
Keywords
Sedation, Pain, Hypnosis, Virtual Reality
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.
Interventions
DEVICEprostate biopsy
prostate biopsies with virtual reality hypnosis headset
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The maximum value of the pain will be collected by the research associate or the coordinating nurse who will be blinded to the randomization arm
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Need for general anesthesia | after the procedure | Rate of need for general anesthesia (in %) |
| 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 |
| 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 |
| Success of biopsies | at 1 month | Number of biopsies performed/planned (ratio), achievement of the MRI target (Yes/no) |
| 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) |
| 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) |
| Qualitative assessment of the patient's experience | after the procedure | Semi-directed interview directly after the procedure |
| Immersion during hypnosis | at the procedure | Immersion scale from 0 to 10 during hypnosis |
Countries
France
Contacts
Primary ContactGaelle GF FIARD, Professor
Backup ContactAssilah AB BOUZIT, study co
Outcome results
None listed