MedDataX Logo

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

NCT ID: NCT03711643

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-07

Study Completion Date

2021-10-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostatic Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

prostatic biopsies echo-guided Pain measurement Anxiety assessment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Optimizing pain management

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

Group Type EXPERIMENTAL

Periprostatic nerve block

Intervention Type PROCEDURE

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

hypnosis mask

Intervention Type 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.

standard pain management

Group Type ACTIVE_COMPARATOR

Periprostatic nerve block

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Periprostatic nerve block

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

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philippe Puech, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Claude Huriez, CHU

Lille, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-A01673-52

Identifier Type: OTHER

Identifier Source: secondary_id

2017_84

Identifier Type: -

Identifier Source: org_study_id