Prostatic Diseases
Conditions
Keywords
prostatic biopsies echo-guided, Pain measurement, Anxiety assessment
Brief summary
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.
Interventions
PROCEDUREPeriprostatic nerve block
4 injections of 2 cc of lidocaine for a Periprostatic nerve block
DEVICEhypnosis mask
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.
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
50 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogic Scale | at 20 minutes after the removal of the probe | Measure the pain in the scale from 0 to 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | at 20 minutes after the removal of the probe | The question is: Would you do prostate biopsy punctures under the same conditions in a month? (Yes: effective method, No: ineffective method). |
| Percentage of positive response of satisfaction of the operator | at 20 minutes after the removal of the probe | The question is: In your opinion, has the gesture been made optimally? (Yes/ No). |
Countries
France
Outcome results
None listed