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

University Hospital, Lille

Status: Completed

Conditions: Prostatic Diseases

Treatments: Device: hypnosis mask; Procedure: Periprostatic nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT03711643

2018-A01673-52 (Other Identifier)

2017_84

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: Male

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Optimizing pain management

Experimental group

Description:

An experimental group receive a standard pain management and benefit the hypnotic mask (Hypnos pro).

Treatment:

Procedure: Periprostatic nerve block

Device: hypnosis mask

standard pain management

Active Comparator group

Treatment:

Procedure: Periprostatic nerve block