Oncology
Conditions
Keywords
central veinous catheter, virtual reality induced hypnosis
Brief summary
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
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.
Interventions
DEVICESedakit (R) using hypnosis induced by the virtual reality device
we use the virtual reality device and no medication during the surgery
using sufentanyl 5mg intravenously during the surgery
Sponsors
Centre Hospitalier Regional de Huy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
the participation in one of the 2 arms is determined randomly just before the implantation
Intervention model description
1 arm with anaesthetic drugs vs hypnosis induced by virtual reality
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* need for a venous device implantation
Exclusion criteria
* need for a general anaesthesia * unability to give oral consent * under 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| successful implantation of a veinous access device | immediately after surgery | we evaluate if the veinous access was implanted successfully with digital or drug sedation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient comfort | during the surgery | we evaluate if the patient needed additional pain killers during the procedure |
| implantation lenght | during the surgery | we evaluate the length of the implantation in minutes with the drug or digital sedation |
| feeling lenght | immediately after the surgery | we evaluate the length of the implantation felt by the patient using drug or digital sedation |
| post operative anxiety using the hamilton anxiety scale | 2 days after the surgery | we do a post operative test to evaluate the level of anxiety after the procedure |
Countries
Belgium
Outcome results
None listed