Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Visual analogic Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
standard pain management
Intervention: Periprostatic nerve block (Procedure)
Optimizing pain management
An experimental group receive a standard pain management and benefit the hypnotic mask (Hypnos pro).
Intervention: Periprostatic nerve block (Procedure)
Optimizing pain management
An experimental group receive a standard pain management and benefit the hypnotic mask (Hypnos pro).
Intervention: hypnosis mask (Device)
Outcomes
Primary Outcomes
Visual analogic Scale
Time Frame: at 20 minutes after the removal of the probe
Measure the pain in the scale from 0 to 10
Secondary Outcomes
- 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 operator(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)