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

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.

Study Overview

• Status: Completed
• Conditions: Oncology
• Intervention / Treatment: Drug: drug intervention; Device: Sedakit (R) using hypnosis induced by the virtual reality device

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Huy, Belgium, 4500
    • CHR de Huy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• need for a venous device implantation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: drug intervention; drug induced sedation	Drug: drug intervention; using sufentanyl 5mg intravenously during the surgery; Other Names: medical sedation
Experimental: digital sedation; hypnosis induced by a virtual reality device	Device: Sedakit (R) using hypnosis induced by the virtual reality device; we use the virtual reality device and no medication during the surgery; Other Names: Oncomfort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient comfort	we evaluate if the patient needed additional pain killers during the procedure	during the surgery
implantation lenght	we evaluate the length of the implantation in minutes with the drug or digital sedation	during the surgery
feeling lenght	we evaluate the length of the implantation felt by the patient using drug or digital sedation	immediately after the surgery
post operative anxiety using the hamilton anxiety scale	we do a post operative test to evaluate the level of anxiety after the procedure	2 days after the surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Regional de Huy
• Investigators: Principal Investigator: JeanFrancois Maillart, MD, CHR de Huy

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): August 22, 2022
• Study Completion (Actual): August 25, 2022

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: central veinous catheter; virtual reality induced hypnosis
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2022 PAC RV vs sed med

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: an article will be published with the results. the results will probably be exposed in a future congress.
• IPD Sharing Time Frame: the data will be available after the official publication for one year
• IPD Sharing Access Criteria: official asking and scientific interest in this study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No