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

Prostatic Diseases Clinical Trial

— HYPNOTIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03711643
• Other study ID #: 2017_84
• Secondary ID: 2018-A01673-52
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2019
• Est. completion date: December 2021

Study information

• Verified date: September 2020
• Source: University Hospital, Lille
• Contact: Philippe Puech, MD,PhD
• Phone: 03 20 44 59 54
• Email: philippe.puech[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Claude Huriez, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogic Scale	Measure the pain in the scale from 0 to 10	at 20 minutes after the removal of the probe
Secondary	State-Trait Anxiety Inventory ou STAI forme Y-A		Baseline, at 20 minutes after the removal of the probe
Secondary	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
Secondary	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