An interventional study of Periprostatic nerve block and hypnosis mask in Prostatic Diseases, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to male participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Supportive care
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.
84 studies on the registry are indexed under Prostatic Diseases; 19 are open to participants now.
This study's enrollment of 88 is above the median of 77 across 66 interventional studies indexed under Prostatic Diseases.
Browse Prostatic Diseases studies →University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An experimental group receive a standard pain management and benefit the hypnotic mask (Hypnos pro).
Procedure: Periprostatic nerve block · Device: hypnosis mask
Procedure: Periprostatic nerve block
4 injections of 2 cc of lidocaine for a Periprostatic nerve block
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.
Visual analogic Scale
Measure the pain in the scale from 0 to 10
Time frame: at 20 minutes after the removal of the probe
State-Trait Anxiety Inventory ou STAI forme Y-A
Time frame: 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).
Time frame: 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).
Time frame: at 20 minutes after the removal of the probe
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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