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Completed

NCT Number: NCT03711643

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

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.

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Key information

Conditions

Prostatic Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Urogenital Diseases

Age range

50 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Claude Huriez, CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Periprostatic nerve block

Procedure

4 injections of 2 cc of lidocaine for a Periprostatic nerve block

hypnosis mask

Device

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.

Primary outcomes

  1. 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

  1. State-Trait Anxiety Inventory ou STAI forme Y-A

    Time frame: Baseline, at 20 minutes after the removal of the probe

  2. Percentage of positive response of satisfaction of the patient

    Time frame: at 20 minutes after the removal of the probe

    The question is: Would you do prostate biopsy punctures under the same conditions in a month? (Yes: effective method, No: ineffective method).

  3. Percentage of positive response of satisfaction of the operator

    Time frame: at 20 minutes after the removal of the probe

    The question is: In your opinion, has the gesture been made optimally? (Yes/ No).

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: HYPNOTIC

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 18, 2018
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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