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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prostate biopsies without virtual reality hypnosis headset | Active Comparator | Biopsies are performed according to current recommendations |
|
| prostate biopsies with virtual reality hypnosis headset | Experimental | Patient wearing a virtual reality headset put in place in the transfer room 15 minutes before the procedure and maintained throughout the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prostate biopsy | Device | prostate biopsies with virtual reality hypnosis headset |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pain after the procedure | Numerical scale 0-10 of pain upon discharge from the hospital | 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 |
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Inclusion Criteria:
Exclusion Criteria:
male
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gaelle GF FIARD, Professor | Contact | 0476767642 | +33 | gfiard@chu-grenoble.fr |
| Assilah AB BOUZIT, study co | Contact | 0476767971 | +33 | abouzit@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Gaelle GF FIARD, professor | university grenoble hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Grenoble | Grenoble | 38043 | France |
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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
|
| after the procedure |
| Immersion during hypnosis | Immersion scale from 0 to 10 during hypnosis | at the procedure |
| Evaluation of the nociceptive response to painful stimuli | Heart rate variability (= HRV) on the ECG trace (in milliseconds) | 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) | 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) | 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) | at 1 month |
| Success of biopsies | Number of biopsies performed/planned (ratio), achievement of the MRI target (Yes/no) | at 1 month |
| Need for general anesthesia | Rate of need for general anesthesia (in %) | 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 | 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 | at 1 month |
| Qualitative assessment of the patient's experience | Semi-directed interview directly after the procedure | after the procedure |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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