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

Oncology Clinical Trial

Official title:

Comparaison Between Virtual Reality Hypnosis and Drug Induced Sedation in Veinous Access Device Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05815056
• Other study ID #: 2022 PAC RV vs sed med
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: August 25, 2022

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Regional de Huy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 25, 2022
• Est. primary completion date: August 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• need for a venous device implantation

Exclusion Criteria:

• need for a general anaesthesia

• unability to give oral consent

• under 18 years

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Intervention

Device:
• Sedakit (R) using hypnosis induced by the virtual reality device
we use the virtual reality device and no medication during the surgery

Drug:
• drug intervention
using sufentanyl 5mg intravenously during the surgery

Locations

Country	Name	City	State
Belgium	CHR de Huy	Huy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Regional de Huy

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	patient comfort	we evaluate if the patient needed additional pain killers during the procedure	during the surgery
Secondary	implantation lenght	we evaluate the length of the implantation in minutes with the drug or digital sedation	during the surgery
Secondary	feeling lenght	we evaluate the length of the implantation felt by the patient using drug or digital sedation	immediately after the surgery
Secondary	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