Prostatic DiseasesHYPNOTICNCT03711643
Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging
A study testing Periprostatic nerve block and hypnosis mask in people with Prostatic Diseases, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostatic Diseases
- What is being tested?
- Periprostatic nerve block and hypnosis mask
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2019to 26 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Prostatic Diseases
- Being tested
- Periprostatic nerve block, hypnosis mask
- Keywords
- prostatic biopsies echo-guided, Pain measurement, Anxiety assessment
- Medical subject headings
- Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periprostatic nerve blockProcedure or surgery
4 injections of 2 cc of lidocaine for a Periprostatic nerve block
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.
| Study group | Role | What they receive |
|---|---|---|
| Optimizing pain management | Experimental | An experimental group receive a standard pain management and benefit the hypnotic mask (Hypnos pro). Receives: Procedure: Periprostatic nerve block; Device: hypnosis mask |
| standard pain management | Active comparator | Not described Receives: Procedure: Periprostatic nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogic Scale
Measure the pain in the scale from 0 to 10
Measured: at 20 minutes after the removal of the probe
Secondary outcomes (3)
State-Trait Anxiety Inventory ou STAI forme Y-A
Measured: 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).
Measured: 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).
Measured: at 20 minutes after the removal of the probe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start7 May 2019
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Puech, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711643
- Sponsor's protocol ID
- 2017_84
- Other IDs
- 2018-A01673-52
- Acronym
- HYPNOTIC
- Status last verified
- Feb 2023
- First submitted
- 16 Oct 2018
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging
- ClinicalTrials.gov ID
- NCT03711643
- Acronym / sponsor ID
- HYPNOTIC / 2017_84
- Conditions
- Prostatic Diseases
- Keywords
- prostatic biopsies echo-guided, Pain measurement, Anxiety assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimizing pain management | Experimental | Procedure: Periprostatic nerve block, Device: hypnosis maskAn experimental group receive a standard pain management and benefit the hypnotic mask (Hypnos pro). |
| standard pain management | Active comparator | Procedure: Periprostatic nerve block |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periprostatic nerve block4 injections of 2 cc of lidocaine for a Periprostatic nerve block | Procedure or surgery | Optimizing pain management, standard pain management |
| hypnosis maskThe 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. | Device | Optimizing pain management |
Primary outcome
Visual analogic Scale
Time frame: at 20 minutes after the removal of the probe
Measure the pain in the scale from 0 to 10
3 secondary outcomes
State-Trait Anxiety Inventory ou STAI forme Y-A
Time frame: Baseline, at 20 minutes after the removal of the probe
Percentage of positive response of satisfaction of the patient
Time frame: at 20 minutes after the removal of the probe
Percentage of positive response of satisfaction of the operator
Time frame: at 20 minutes after the removal of the probe
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Puech, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periprostatic nerve block and hypnosis mask in people with Prostatic Diseases, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogic Scale (time frame: at 20 minutes after the removal of the probe). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.