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

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 Overview

• Status: Completed
• Conditions: Prostatic Diseases
• Intervention / Treatment: Procedure: Periprostatic nerve block; Device: hypnosis mask

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Claude Huriez, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogic Scale	Measure the pain in the scale from 0 to 10	at 20 minutes after the removal of the probe

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 patient	The question is: Would you do prostate biopsy punctures under the same conditions in a month? (Yes: effective method, No: ineffective method).	at 20 minutes after the removal of the probe
Percentage of positive response of satisfaction of the operator	The question is: In your opinion, has the gesture been made optimally? (Yes/ No).	at 20 minutes after the removal of the probe

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Philippe Puech, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2019
• Primary Completion (Actual): October 26, 2021
• Study Completion (Actual): October 26, 2021

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Pain measurement; prostatic biopsies echo-guided; Anxiety assessment
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Prostatic Diseases
• Other Study ID Numbers: 2017_84; 2018-A01673-52 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No