Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions

Study Overview
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Brief Summary
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The aim of our study is to compare patients anxiety and pain during percutaneous vascular interventions with and without virtual reality autohypnosis.

Detailed Description
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The participants in the control group will be treated under local anesthesia, following the usual care protocols. The participants in the experimental group will be treated under the same conditions, except that they will experience virtual reality autohypnosis during the intervention.

Official Title
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Virtually Augmented Self Hypnosis: Randomized Controlled Trial in Peripheral Vascular Interventions

Conditions
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Anxiety Postoperative, Pain, Postoperative, Vascular Access Site Pain

Intervention / Treatment
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* Device: OnComfort autohypnosis
* Other: Treatment as usual, without the OnComfort autohypnosis system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent as documented by signature > 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: No French language comprehension, deaf or visually impaired patient 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autohypnosis<br>Use of virtual reality with head mounted display | Device: OnComfort autohypnosis<br>* 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.<br>|
| Other: Control<br>Treatment as usual | Other: Treatment as usual, without the OnComfort autohypnosis system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per procedural anxiety. | Per procedural anxiety, measured by the Spielberger Anxiety State Inventory in French (Gauthier and Bouchard, 1993). The Spielberger Anxiety State Inventory is a self questionnaire of 20 items, each item scores from 1 to 4. The result of the test is the sum of the 20 items, therefore the result ranges from 20 to 80. A high score is related to a high level of anxiety at the moment of the test. | Day 1 (Immediately after the peripheral vascular intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per procedural pain. | Per procedural pain, measured by the visual analog pain scale. The visual analog pain scale rates pain from 0 to 10, 0 being the least pain imaginable and 10 the maximal pain imaginable. | Day 1 (Immediately after the peripheral vascular intervention) | 
| Remembered per procedural anxiety. | Remembered per procedural anxiety measured by the Spielberg Anxiety State Inventory in French (Gauthier and Bouchard, 1993). The Spielberger Anxiety State Inventory is a self questionnaire of 20 items, each item scores from 1 to 4. The result of the test is the sum of the 20 items, therefore the result ranges from 20 to 80. A high score is related to a high level of anxiety at the moment of the test. | 3 months | 
| Remembered per procedural pain. | Remembered per procedural pain will be measured by the visual analog pain scale. The visual analog pain scale rates pain from 0 to 10, 0 being the least pain imaginable and 10 the maximal pain imaginable. | 3 months | 
| Adverse events | Device deficiencies | Day 1 | 
| Serious adverse events | Amputation, mesenteric or renal ischemia, and death | Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypnosis, Anxiety, Pain, Virtual reality, Virtual reality autohypnosis, Non-pharmacological approaches