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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01673-52 | Other Identifier | ID-RCB number, ANSM |
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The prostatic biopsies echo-guided are a painful and stressful. The purpose is to test a new medical device created recently, " Hypnos-Pro ", wich uses connected technologies. This connected device is a mask with diodes coupled with an audio headset and a touch pad. This connected mask is an another option to induce an hypnotic state for our patients. the objective is to value hypnotic mask effectiveness, to reduce the level pain and anxiety for the patients who benefit a prostatic biopsies echo-guided with local anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimizing pain management | Experimental | An experimental group receive a standard pain management and benefit the hypnotic mask (Hypnos pro). |
|
| standard pain management | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periprostatic nerve block | Procedure | 4 injections of 2 cc of lidocaine for a Periprostatic nerve block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogic Scale | Measure the pain in the scale from 0 to 10 | at 20 minutes after the removal of the probe |
| Measure | Description | Time Frame |
|---|---|---|
| State-Trait Anxiety Inventory ou STAI forme Y-A | Baseline, at 20 minutes after the removal of the probe | |
| Percentage of positive response of satisfaction of the patient | The question is: Would you do prostate biopsy punctures under the same conditions in a month? (Yes: effective method, No: ineffective method). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Puech, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Claude Huriez, CHU | Lille | France |
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| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| hypnosis mask | Device | The mask HYPNOS pro stimulates the imagination of the user by means of 6 diodes among 3 by eye. Just before the introduction of ultrasound probe, the patient put the hypnotic mask and choose a session.Twenty minutes after the removal of the probe, an healthworker assess the painful patient with the visual analogue scale VAS, after this the patient fulfill the STATE- TRAIT Anxiety Inventory (STAI) form Y-A. |
|
| at 20 minutes after the removal of the probe |
| Percentage of positive response of satisfaction of the operator | The question is: In your opinion, has the gesture been made optimally? (Yes/ No). | at 20 minutes after the removal of the probe |