Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging

Study Overview
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Brief Summary
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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.

Official Title
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Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging

Conditions
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Prostatic Diseases

Intervention / Treatment
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* Procedure: Periprostatic nerve block
* Device: hypnosis mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient eligible for prostate biopsies Having accepted and signed the consent, for performing a prostate biopsy ultrasound examination No contraindication to the gesture Supporting the left lateral decubitus Exclusion Criteria: Patient isolation contact / droplets Patient with hearing and / or epilepticus and / or dementia and / or having a history of stroke and / or allergic to lidocaine Person unable to consent, or benefiting from a system of legal protection (tutelage / curatorship). Patients with epileptic seizures. Patients with known allergies to plastics and other resins that may develop allergic contact dermatitis. Patients who are hypersensitive to radio frequency. Patients with Rocephin administration before the gesture

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optimizing pain management<br>An experimental group receive a standard pain management and benefit the hypnotic mask (Hypnos pro). | Procedure: Periprostatic nerve block<br>* 4 injections of 2 cc of lidocaine for a Periprostatic nerve block<br>Device: hypnosis mask<br>* 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.<br>|
| Active Comparator: standard pain management<br> | Procedure: Periprostatic nerve block<br>* 4 injections of 2 cc of lidocaine for a Periprostatic nerve block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostatic biopsies echo-guided, Pain measurement, Anxiety assessment