Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions
Primary Purpose
Anxiety Postoperative, Pain, Postoperative, Vascular Access Site Pain
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
OnComfort autohypnosis
Treatment as usual, without the OnComfort autohypnosis system
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Postoperative focused on measuring Anxiety, Pain, Virtual reality, Virtual reality autohypnosis, Hypnosis, Non-pharmacological approaches
Eligibility Criteria
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
Sites / Locations
- CHUV
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Autohypnosis
Control
Arm Description
Use of virtual reality with head mounted display
Treatment as usual
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Adverse events
Device deficiencies
Serious adverse events
Amputation, mesenteric or renal ischemia, and death
Full Information
NCT ID
NCT04561596
First Posted
September 9, 2020
Last Updated
September 27, 2022
Sponsor
Salah D. Qanadli, MD, PhD
1. Study Identification
Unique Protocol Identification Number
NCT04561596
Brief Title
Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions
Official Title
Virtually Augmented Self Hypnosis: Randomized Controlled Trial in Peripheral Vascular Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
October 5, 2020 (Actual)
Study Completion Date
August 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Salah D. Qanadli, MD, PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of our study is to compare patients anxiety and pain during percutaneous vascular interventions with and without virtual reality autohypnosis.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Postoperative, Pain, Postoperative, Vascular Access Site Pain
Keywords
Anxiety, Pain, Virtual reality, Virtual reality autohypnosis, Hypnosis, Non-pharmacological approaches
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autohypnosis
Arm Type
Experimental
Arm Description
Use of virtual reality with head mounted display
Arm Title
Control
Arm Type
Other
Arm Description
Treatment as usual
Intervention Type
Device
Intervention Name(s)
OnComfort autohypnosis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual, without the OnComfort autohypnosis system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Per procedural anxiety.
Description
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.
Time Frame
Day 1 (Immediately after the peripheral vascular intervention)
Secondary Outcome Measure Information:
Title
Per procedural pain.
Description
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.
Time Frame
Day 1 (Immediately after the peripheral vascular intervention)
Title
Remembered per procedural anxiety.
Description
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.
Time Frame
3 months
Title
Remembered per procedural pain.
Description
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.
Time Frame
3 months
Title
Adverse events
Description
Device deficiencies
Time Frame
Day 1
Title
Serious adverse events
Description
Amputation, mesenteric or renal ischemia, and death
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salah Dine Qanadli, Prof. MD PhD
Organizational Affiliation
Unil, CHUV
Official's Role
Study Director
Facility Information:
Facility Name
CHUV
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35196310
Citation
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.
Results Reference
derived
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Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions
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