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

Sponsor
Centre Hospitalier Regional de Huy (Other)
Overall Status
Completed
CT.gov ID
NCT05815056
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
5.8
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Sedakit (R) using hypnosis induced by the virtual reality device
  • Drug: drug intervention
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1 arm with anaesthetic drugs vs hypnosis induced by virtual reality1 arm with anaesthetic drugs vs hypnosis induced by virtual reality
Masking:
None (Open Label)
Masking Description:
the participation in one of the 2 arms is determined randomly just before the implantation
Primary Purpose:
Treatment
Official Title:
Comparaison Between Virtual Reality Hypnosis and Drug Induced Sedation in Veinous Access Device Implantation
Actual Study Start Date :
Mar 1, 2022
Actual Primary Completion Date :
Aug 22, 2022
Actual Study Completion Date :
Aug 25, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. patient comfort [during the surgery]

      we evaluate if the patient needed additional pain killers during the procedure

    2. implantation lenght [during the surgery]

      we evaluate the length of the implantation in minutes with the drug or digital sedation

    3. feeling lenght [immediately after the surgery]

      we evaluate the length of the implantation felt by the patient using drug or digital sedation

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • need for a venous device implantation
    Exclusion Criteria:

    • need for a general anaesthesia

    • unability to give oral consent

    • under 18 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHR de Huy Huy Belgium 4500

    Sponsors and Collaborators

    • Centre Hospitalier Regional de Huy

    Investigators

    • Principal Investigator: JeanFrancois Maillart, MD, CHR de Huy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Regional de Huy
    ClinicalTrials.gov Identifier:
    NCT05815056
    Other Study ID Numbers:
    • 2022 PAC RV vs sed med
    First Posted:
    Apr 18, 2023
    Last Update Posted:
    Apr 18, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Regional de Huy
    central veinous catheter
    virtual reality induced hypnosis
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Apr 18, 2023