Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging (HYPNOTIC)
Primary Purpose
Prostatic Diseases
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Periprostatic nerve block
hypnosis mask
Sponsored by
About this trial
This is an interventional supportive care trial for Prostatic Diseases focused on measuring prostatic biopsies echo-guided, Pain measurement, Anxiety assessment
Eligibility 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
Sites / Locations
- Hôpital Claude Huriez, CHURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Optimizing pain management
standard pain management
Arm Description
An experimental group receive a standard pain management and benefit the hypnotic mask (Hypnos pro).
Outcomes
Primary Outcome Measures
Visual analogic Scale
Measure the pain in the scale from 0 to 10
Secondary Outcome Measures
State-Trait Anxiety Inventory ou STAI forme Y-A
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).
Percentage of positive response of satisfaction of the operator
The question is: In your opinion, has the gesture been made optimally? (Yes/ No).
Full Information
NCT ID
NCT03711643
First Posted
October 16, 2018
Last Updated
September 10, 2020
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT03711643
Brief Title
Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging
Acronym
HYPNOTIC
Official Title
Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Diseases
Keywords
prostatic biopsies echo-guided, Pain measurement, Anxiety assessment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
172 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Optimizing pain management
Arm Type
Experimental
Arm Description
An experimental group receive a standard pain management and benefit the hypnotic mask (Hypnos pro).
Arm Title
standard pain management
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Periprostatic nerve block
Intervention Description
4 injections of 2 cc of lidocaine for a Periprostatic nerve block
Intervention Type
Device
Intervention Name(s)
hypnosis mask
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analogic Scale
Description
Measure the pain in the scale from 0 to 10
Time Frame
at 20 minutes after the removal of the probe
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory ou STAI forme Y-A
Time Frame
Baseline, at 20 minutes after the removal of the probe
Title
Percentage of positive response of satisfaction of the patient
Description
The question is: Would you do prostate biopsy punctures under the same conditions in a month? (Yes: effective method, No: ineffective method).
Time Frame
at 20 minutes after the removal of the probe
Title
Percentage of positive response of satisfaction of the operator
Description
The question is: In your opinion, has the gesture been made optimally? (Yes/ No).
Time Frame
at 20 minutes after the removal of the probe
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Puech, MD,PhD
Phone
03 20 44 59 54
Ext
+33
Email
philippe.puech@chru-lille.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Brigitte Cortes_Demailly, MD,PhD
Email
brigitte.demailly@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Puech, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Claude Huriez, CHU
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Puech, MD,PhD
12. IPD Sharing Statement
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Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging
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