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

Last updated: September 10, 2020
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Disorders

Treatment

N/A

Clinical Study ID

NCT03711643
2017_84
2018-A01673-52
  • Ages 50-75
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient eligible for prostate biopsies

  • Having accepted and signed the consent, for performing a prostate biopsy ultrasoundexamination

  • No contraindication to the gesture

  • Supporting the left lateral decubitus

Exclusion

Exclusion Criteria:

  • Patient isolation contact / droplets

  • Patient with hearing and / or epilepticus and / or dementia and / or having a historyof 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 allergiccontact dermatitis.

  • Patients who are hypersensitive to radio frequency.

  • Patients with Rocephin administration before the gesture

Study Design

Total Participants: 172
Study Start date:
May 07, 2019
Estimated Completion Date:
December 31, 2021

Connect with a study center

  • Hôpital Claude Huriez, CHU

    Lille,
    France

    Active - Recruiting

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