NCT03711643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

May 7, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2021

Completed
Last Updated

December 23, 2025

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

October 16, 2018

Last Update Submit

December 16, 2025

Conditions

Prostatic Diseases

Keywords

prostatic biopsies echo-guidedPain measurementAnxiety assessment

Outcome Measures

Primary Outcomes (1)

  • Visual analogic Scale

    Measure the pain in the scale from 0 to 10

    at 20 minutes after the removal of the probe

Secondary Outcomes (3)

  • 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

    at 20 minutes after the removal of the probe

  • Percentage of positive response of satisfaction of the operator

    at 20 minutes after the removal of the probe

Study Arms (2)

Optimizing pain management

EXPERIMENTAL

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

Procedure: Periprostatic nerve blockDevice: hypnosis mask

standard pain management

ACTIVE COMPARATOR
Procedure: Periprostatic nerve block

Interventions

Periprostatic nerve blockPROCEDURE

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

Optimizing pain managementstandard pain management
hypnosis maskDEVICE

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.

Optimizing pain management

Eligibility Criteria

Age50 Years - 75 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Claude Huriez, CHU

Lille, France

Location

MeSH Terms

Conditions

Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Philippe Puech, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2018

First Posted

October 18, 2018

Study Start

May 7, 2019

Primary Completion

October 26, 2021

Study Completion

October 26, 2021

Last Updated

December 23, 2025

Record last verified: 2023-02

Locations

FR(1)