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

Not Applicable

Completed

• Conditions: Oncology
• Interventions: Drug: drug intervention; Device: Sedakit (R) using hypnosis induced by the virtual reality device

• Registration Number: NCT05815056
• Lead Sponsor: Centre Hospitalier Regional de Huy

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 Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-08-22
• Study Completion: 2022-08-25
• Study First Submitted: 2023-02-06
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-03
• Last Update Submitted: 2023-04-03
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• need for a venous device implantation

Exclusion Criteria

• need for a general anaesthesia
• unability to give oral consent
• under 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug intervention	drug intervention	drug induced sedation
digital sedation	Sedakit (R) using hypnosis induced by the virtual reality device	hypnosis induced by a virtual reality device

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
patient comfort	during the surgery	we evaluate if the patient needed additional pain killers during the procedure
feeling lenght	immediately after the surgery	we evaluate the length of the implantation felt by the patient using drug or digital sedation
implantation lenght	during the surgery	we evaluate the length of the implantation in minutes with the 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

Trial Locations

Locations (1)

CHR de Huy; 🇧🇪 Huy, Belgium