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

Centre Hospitalier Regional de Huy

Status: Completed

Conditions: Oncology

Treatments: Device: Sedakit (R) using hypnosis induced by the virtual reality device; Drug: drug intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05815056

2022 PAC RV vs sed med

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• need for a venous device implantation

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

drug intervention

Active Comparator group

Description:

drug induced sedation

Treatment:

Drug: drug intervention

digital sedation

Experimental group

Description:

hypnosis induced by a virtual reality device

Treatment:

Device: Sedakit (R) using hypnosis induced by the virtual reality device