OncologyNCT05815056
Comparaison Between Digital and Drug Induced Sedation in Veinous Access Device Implantation
A study testing Sedakit (R) using hypnosis induced by the virtual reality device and drug intervention in people with Oncology, run by Centre Hospitalier Regional de Huy at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- Sedakit (R) using hypnosis induced by the virtual reality device and drug intervention
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2022to 25 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- need for a venous device implantation
Who cannot join
- need for a general anaesthesia
- unability to give oral consent
- under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparaison Between Virtual Reality Hypnosis and Drug Induced Sedation in Veinous Access Device Implantation
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.
Read the 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.
- Conditions
- Oncology
- Being tested
- Sedakit (R) using hypnosis induced by the virtual reality device, drug intervention
- Keywords
- central veinous catheter, virtual reality induced hypnosis
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedakit (R) using hypnosis induced by the virtual reality deviceDevice
Also called Oncomfort
we use the virtual reality device and no medication during the surgery
drug interventionDrug
Also called medical sedation
using sufentanyl 5mg intravenously during the surgery
| Study group | Role | What they receive |
|---|---|---|
| drug intervention | Active comparator | drug induced sedation Receives: Drug: drug intervention |
| digital sedation | Experimental | hypnosis induced by a virtual reality device Receives: Device: Sedakit (R) using hypnosis induced by the virtual reality device |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful implantation of a veinous access device
we evaluate if the veinous access was implanted successfully with digital or drug sedation
Measured: immediately after surgery
Secondary outcomes (4)
patient comfort
we evaluate if the patient needed additional pain killers during the procedure
Measured: during the surgery
implantation lenght
we evaluate the length of the implantation in minutes with the drug or digital sedation
Measured: during the surgery
feeling lenght
we evaluate the length of the implantation felt by the patient using drug or digital sedation
Measured: immediately after the surgery
post operative anxiety using the hamilton anxiety scale
we do a post operative test to evaluate the level of anxiety after the procedure
Measured: 2 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Mar 2022
- Primary completion22 Aug 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 arm with anaesthetic drugs vs hypnosis induced by virtual reality
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Regional de Huy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JeanFrancois Maillart, MD, Principal investigator, CHR de Huy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815056
- Sponsor's protocol ID
- 2022 PAC RV vs sed med
- Status last verified
- Apr 2023
- First submitted
- 6 Feb 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: an article will be published with the results. the results will probably be exposed in a future congress.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparaison Between Virtual Reality Hypnosis and Drug Induced Sedation in Veinous Access Device Implantation
- ClinicalTrials.gov ID
- NCT05815056
- Acronym / sponsor ID
- 2022 PAC RV vs sed med
- Conditions
- Oncology
- Keywords
- central veinous catheter, virtual reality induced hypnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Regional de HuyUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1 arm with anaesthetic drugs vs hypnosis induced by virtual reality
| Arm | Type | Receives |
|---|---|---|
| drug intervention | Active comparator | Drug: drug interventiondrug induced sedation |
| digital sedation | Experimental | Device: Sedakit (R) using hypnosis induced by the virtual reality devicehypnosis induced by a virtual reality device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- need for a venous device implantation
Key exclusion criteria (3 listed)
- need for a general anaesthesia
- unability to give oral consent
- under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedakit (R) using hypnosis induced by the virtual reality deviceAlso: Oncomfortwe use the virtual reality device and no medication during the surgery | Device | digital sedation |
| drug interventionAlso: medical sedationusing sufentanyl 5mg intravenously during the surgery | Drug | drug intervention |
Primary outcome
successful implantation of a veinous access device
Time frame: immediately after surgery
we evaluate if the veinous access was implanted successfully with digital or drug sedation
4 secondary outcomes
patient comfort
Time frame: during the surgery
implantation lenght
Time frame: during the surgery
feeling lenght
Time frame: immediately after the surgery
post operative anxiety using the hamilton anxiety scale
Time frame: 2 days after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Yes. an article will be published with the results. the results will probably be exposed in a future congress.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JeanFrancois Maillart, MD principal investigator
CHR de Huy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedakit (R) using hypnosis induced by the virtual reality device and drug intervention in people with Oncology, run by Centre Hospitalier Regional de Huy at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful implantation of a veinous access device (time frame: immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.