Trials / Completed
CompletedNCT03711643
Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- University Hospital, Lille · Academic / Other
- Sex
- Male
- Age
- 50 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-05-07
- Primary completion
- 2021-10-26
- Completion
- 2021-10-26
- First posted
- 2018-10-18
- Last updated
- 2025-12-23
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03711643. Inclusion in this directory is not an endorsement.