Comparaison Between Virtual Reality Hypnosis and Drug Induced Sedation in Veinous Access Device Implantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- successful implantation of a veinous access device
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
drug intervention
drug induced sedation
Intervention: drug intervention (Drug)
digital sedation
hypnosis induced by a virtual reality device
Intervention: Sedakit (R) using hypnosis induced by the virtual reality device (Device)
Outcomes
Primary Outcomes
successful implantation of a veinous access device
Time Frame: immediately after surgery
we evaluate if the veinous access was implanted successfully with digital or drug sedation
Secondary Outcomes
- patient comfort(during the surgery)
- feeling lenght(immediately after the surgery)
- implantation lenght(during the surgery)
- post operative anxiety using the hamilton anxiety scale(2 days after the surgery)