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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03711643
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease Intervention/treatment Phase
Prostatic Diseases Procedure: Periprostatic nerve block Device: hypnosis mask Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Optimizing pain management
An experimental group receive a standard pain management and benefit the hypnotic mask (Hypnos pro).
Procedure: Periprostatic nerve block
4 injections of 2 cc of lidocaine for a Periprostatic nerve block

Device: hypnosis mask

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.


Active Comparator: standard pain management Procedure: Periprostatic nerve block
4 injections of 2 cc of lidocaine for a Periprostatic nerve block




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.
  • Patients with Rocephin administration before the gesture

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711643


Contacts
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Contact: Philippe Puech, MD,PhD 03 20 44 59 54 ext +33 philippe.puech@chru-lille.fr
Contact: Brigitte Cortes_Demailly, MD,PhD brigitte.demailly@chru-lille.fr

Locations
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France
Hôpital Claude Huriez, CHU Recruiting
Lille, France
Principal Investigator: Philippe Puech, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Philippe Puech, MD,PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03711643    
Other Study ID Numbers: 2017_84
2018-A01673-52 ( Other Identifier: ID-RCB number, ANSM )
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
prostatic biopsies echo-guided
Pain measurement
Anxiety assessment
Additional relevant MeSH terms:
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Prostatic Diseases
Genital Diseases, Male