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

NCT05815056 | Completed

• 1 other identifier: 2022 PAC RV vs sed med
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology

Keywords

central veinous catheter; virtual reality induced hypnosis

Outcome Measures

Primary Outcomes (1)

• successful implantation of a veinous access device

  we evaluate if the veinous access was implanted successfully with digital or drug sedation

  immediately after surgery

Secondary Outcomes (4)

• patient comfort

  during the surgery

• implantation lenght

  during the surgery

• feeling lenght

  immediately after the surgery

• post operative anxiety using the hamilton anxiety scale

  2 days after the surgery

Study Arms (2)

drug intervention

ACTIVE COMPARATOR

drug induced sedation

Drug: drug intervention

digital sedation

EXPERIMENTAL

hypnosis induced by a virtual reality device

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

Interventions

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

we use the virtual reality device and no medication during the surgery

Also known as: Oncomfort

digital sedation

drug intervention DRUG

using sufentanyl 5mg intravenously during the surgery

Also known as: medical sedation

drug intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• need for a venous device implantation

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Regional de Huy: lead

Study Sites (1)

CHR de Huy

Huy, 4500, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• JeanFrancois Maillart, MD

  CHR de Huy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: the participation in one of the 2 arms is determined randomly just before the implantation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1 arm with anaesthetic drugs vs hypnosis induced by virtual reality

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: April 18, 2023
• Study Start: March 1, 2022
• Primary Completion: August 22, 2022
• Study Completion: August 25, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: the data will be available after the official publication for one year
• Access Criteria: official asking and scientific interest in this study.

Locations

BE (1)