Comparaison Between Digital and Drug Induced Sedation in Veinous Access Device Implantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparaison Between Virtual Reality Hypnosis and Drug Induced Sedation in Veinous Access Device Implantation

Conditions
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Oncology

Intervention / Treatment
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* Device: Sedakit (R) using hypnosis induced by the virtual reality device
* Drug: drug intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: need for a venous device implantation Exclusion Criteria: need for a general anaesthesia unability to give oral consent under 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1 arm with anaesthetic drugs vs hypnosis induced by virtual reality
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: drug intervention<br>drug induced sedation | Drug: drug intervention<br>* using sufentanyl 5mg intravenously during the surgery<br>* Other names: medical sedation;|
| Experimental: digital sedation<br>hypnosis induced by a virtual reality device | Device: Sedakit (R) using hypnosis induced by the virtual reality device<br>* we use the virtual reality device and no medication during the surgery<br>* Other names: Oncomfort;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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central veinous catheter, virtual reality induced hypnosis