Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions
NCT ID: NCT04561596
Last Updated: 2022-09-30
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
100 participants
INTERVENTIONAL
2020-09-23
2022-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Healthy Volunteer Undergoing Painful Stimuli With and Without Hypnosis and Virtual Reality
NCT04107558
Virtual Reality Use for Peri-Procedural Analgesia and Anxiolysis
NCT04218396
Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery
NCT07013695
Virtual Sedation During Elective Procedures in the Cathlab
NCT06171620
Patient Receptiveness to Using Virtual Reality
NCT03528668
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The participants in the experimental group will be treated under the same conditions, except that they will experience virtual reality autohypnosis during the intervention.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Autohypnosis
Use of virtual reality with head mounted display
OnComfort autohypnosis
Participant arrive in our day care clinic and is prepared as any other patient in interventional radiology. The investigator will collect the signed informed consent form and proceed to randomization.
The participant will then fill the pre and post-operative anxiety and pain questionnaire.
The percutaneous vascular procedure will be performed as usual except for the virtual reality mask and autohypnosis software that will run during the whole intervention.
Pain and anxiolytic medication are provided if needed during the intervention. Immediately after the intervention, the participant will fill the post-operative anxiety and pain questionnaire. The participant will be instructed to report anxiety and pain felt during the intervention.
A clinical visit at 3 month is conducted as part of the standard clinical protocol. The participant will fill a 3rd questionnaire about the remembered anxiety and pain during the intervention.
Control
Treatment as usual
Treatment as usual, without the OnComfort autohypnosis system
The Participant arrive in our day care clinic and is prepared as any other patient in interventional radiology. The investigator will collect the signed informed consent form and proceed to randomization.
The participant will then fill the pre and post-operative anxiety and pain questionnaire.
The percutaneous vascular procedure will be performed as usual. Pain and anxiolytic medication are provided if needed during the intervention. Immediately after the intervention, the participant will fill the post-operative anxiety and pain questionnaire. The participant will be instructed to report anxiety and pain felt during the intervention.
A clinical visit at 3 month is conducted as part of the standard clinical protocol. The participant will fill a 3rd questionnaire about the remembered anxiety and pain during the intervention.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OnComfort autohypnosis
Participant arrive in our day care clinic and is prepared as any other patient in interventional radiology. The investigator will collect the signed informed consent form and proceed to randomization.
The participant will then fill the pre and post-operative anxiety and pain questionnaire.
The percutaneous vascular procedure will be performed as usual except for the virtual reality mask and autohypnosis software that will run during the whole intervention.
Pain and anxiolytic medication are provided if needed during the intervention. Immediately after the intervention, the participant will fill the post-operative anxiety and pain questionnaire. The participant will be instructed to report anxiety and pain felt during the intervention.
A clinical visit at 3 month is conducted as part of the standard clinical protocol. The participant will fill a 3rd questionnaire about the remembered anxiety and pain during the intervention.
Treatment as usual, without the OnComfort autohypnosis system
The Participant arrive in our day care clinic and is prepared as any other patient in interventional radiology. The investigator will collect the signed informed consent form and proceed to randomization.
The participant will then fill the pre and post-operative anxiety and pain questionnaire.
The percutaneous vascular procedure will be performed as usual. Pain and anxiolytic medication are provided if needed during the intervention. Immediately after the intervention, the participant will fill the post-operative anxiety and pain questionnaire. The participant will be instructed to report anxiety and pain felt during the intervention.
A clinical visit at 3 month is conducted as part of the standard clinical protocol. The participant will fill a 3rd questionnaire about the remembered anxiety and pain during the intervention.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* \> 18 years
* Any indication for a percutaneous vascular interventional with a single vascular access (angiography, phlebography, arterial intervention, venous intervention) planned to be done under local anesthesia
Exclusion Criteria
* Inability to sign informed consent
* Need of sedative medication
* History of motion sickness
* History of psychiatric disease such as paranoia, schizophrenia, deep water phobia and dementia
* Patient does not tolerate the virtual reality mask during the pre operative visit at Day 1
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Salah D. Qanadli, MD, PhD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Salah D. Qanadli, MD, PhD
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Salah Dine Qanadli, Prof. MD PhD
Role: STUDY_DIRECTOR
Unil, CHUV
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHUV
Lausanne, Canton of Vaud, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gullo G, Rotzinger DC, Colin A, Frossard P, Gudmundsson L, Jouannic AM, Qanadli SD. Virtually Augmented Self-Hypnosis in Peripheral Vascular Intervention: A Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2023 Jun;46(6):786-793. doi: 10.1007/s00270-023-03394-1. Epub 2023 Mar 21.
Qanadli SD, Gudmundsson L, Gullo G, Ponti A, Saltiel S, Jouannic AM, Faouzi M, Rotzinger DC. Virtually Augmented Self-Hypnosis applied to endovascular interventions (VA-HYPO): Randomized Controlled Trial Protocol. PLoS One. 2022 Feb 23;17(2):e0263002. doi: 10.1371/journal.pone.0263002. eCollection 2022.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-00728
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.