Informations générales (source: ClinicalTrials.gov)
Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging (HYPNOTIC)
Interventional
N/A
University Hospital, Lille (Voir sur ClinicalTrials)
mai 2019
décembre 2021
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital Claude Huriez, CHU - Lille - France | Contact (sur clinicalTrials) | ||||
Critères
Homme
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
- 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
- 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