Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05815056
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2023-02-06
Brief Title:
Comparaison Between Digital and Drug Induced Sedation in Veinous Access Device Implantation
Sponsor:
Centre Hospitalier Regional de Huy
Organization:
Centre Hospitalier Regional de Huy
Study Overview
Official Title:
Comparaison Between Virtual Reality Hypnosis and Drug Induced Sedation in Veinous Access Device Implantation
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
This study has two arms All patients has the same preparation to surgery They had lorazepam 25 mg 30 minutes before the surgery In operative theater they are randomly chosen between anesthetic protocol sufentanyl 5mg intravenous or digital sedation SedakitR 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None