Comparaison Between Digital and Drug Induced Sedation in Veinous Access Device Implantation
NCT ID: NCT05815056
Last Updated: 2023-04-18
Study Results
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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COMPLETED
NA
20 participants
INTERVENTIONAL
2022-03-01
2022-08-25
Brief Summary
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• 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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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drug intervention
drug induced sedation
drug intervention
using sufentanyl 5mg intravenously during the surgery
digital sedation
hypnosis induced by a virtual reality device
Sedakit (R) using hypnosis induced by the virtual reality 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
drug intervention
using sufentanyl 5mg intravenously during the surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* unability to give oral consent
* under 18 years
18 Years
ALL
No
Sponsors
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Centre Hospitalier Regional de Huy
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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2022 PAC RV vs sed med
Identifier Type: -
Identifier Source: org_study_id
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