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

NCT ID: NCT05815056

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-08-25

Brief Summary

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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

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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.

Conditions

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Oncology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1 arm with anaesthetic drugs vs hypnosis induced by virtual reality
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

the participation in one of the 2 arms is determined randomly just before the implantation

Study Groups

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drug intervention

drug induced sedation

Group Type ACTIVE_COMPARATOR

drug intervention

Intervention Type DRUG

using sufentanyl 5mg intravenously during the surgery

digital sedation

hypnosis induced by a virtual reality device

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DEVICE

drug intervention

using sufentanyl 5mg intravenously during the surgery

Intervention Type DRUG

Other Intervention Names

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Oncomfort medical sedation

Eligibility Criteria

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Inclusion Criteria

* need for a venous device implantation

Exclusion Criteria

* need for a general anaesthesia
* unability to give oral consent
* under 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Regional de Huy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JeanFrancois Maillart, MD

Role: PRINCIPAL_INVESTIGATOR

CHR de Huy

Locations

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CHR de Huy

Huy, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2022 PAC RV vs sed med

Identifier Type: -

Identifier Source: org_study_id

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