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The goal of this clinical trial is to compare in patients who need an implantation of a veinous access device the sedation with anesthesiologic drugs and with hypnosis using virtual reality material. The main question it aims to answer is:
• is hypnosis using virtual reality as safe and powerfull than usual anesthesiologic drugs.
Participants will complete a preoperative and postoperative questionnaire. They will be contacted by phone pre and postoperatively.
If there is a comparison group: Researchers will compare drug induced sedation and hypnosis induced by virtual reality to see if they are similar in efficacy and sides effects.
This study has two arms. All patients has the same preparation to surgery. They had lorazepam 2.5 mg 30 minutes before the surgery. In operative theater, they are randomly chosen between anesthetic protocol (sufentanyl 5mg intravenous) or digital sedation (Sedakit(R) ) with hypnosis induced by virtual reality.
Patients complete an anxiety test (hamilton scale) 2 days before the surgery and 2 days after the surgery. They are called by an external psychiatrist 1 day before the surgery and 3 days after to evaluate the anxiety link to the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| drug intervention | Active Comparator | drug induced sedation |
|
| digital sedation | Experimental | hypnosis induced by a virtual reality device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedakit (R) using hypnosis induced by the virtual reality device | Device | we use the virtual reality device and no medication during the surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| successful implantation of a veinous access device | we evaluate if the veinous access was implanted successfully with digital or drug sedation | immediately after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| patient comfort | we evaluate if the patient needed additional pain killers during the procedure | during the surgery |
| implantation lenght | we evaluate the length of the implantation in minutes with the drug or digital sedation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JeanFrancois Maillart, MD | CHR de Huy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR de Huy | Huy | 4500 | Belgium |
an article will be published with the results. the results will probably be exposed in a future congress.
the data will be available after the official publication for one year
official asking and scientific interest in this study.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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1 arm with anaesthetic drugs vs hypnosis induced by virtual reality
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the participation in one of the 2 arms is determined randomly just before the implantation
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| drug intervention | Drug | using sufentanyl 5mg intravenously during the surgery |
|
|
| during the surgery |
| feeling lenght | we evaluate the length of the implantation felt by the patient using drug or digital sedation | immediately after the surgery |
| post operative anxiety using the hamilton anxiety scale | we do a post operative test to evaluate the level of anxiety after the procedure | 2 days after the surgery |