NCT05815056

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Centre Hospitalier Regional de Huy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oncology

Interventions

Type	Name	Description
DEVICE	Sedakit (R) using hypnosis induced by the virtual reality device	we use the virtual reality device and no medication during the surgery
DRUG	drug intervention	using sufentanyl 5mg intravenously during the surgery

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-08-22
• Completion: 2022-08-25
• First posted: 2023-04-18
• Last updated: 2023-04-18

Locations

1 site across 1 country: Belgium