An interventional study of OnComfort autohypnosis and Treatment as usual, without the OnComfort autohypnosis system in Anxiety Postoperative, Pain, Postoperative and Vascular Access Site Pain, sponsored by Salah D. Qanadli, MD, PhD. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-30.
Sponsored by Salah D. Qanadli, MD, PhD · Not applicable, Interventional, and Treatment
The aim of our study is to compare patients anxiety and pain during percutaneous vascular interventions with and without virtual reality autohypnosis.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 100 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →This is the only study on the registry with Salah D. Qanadli, MD, PhD as lead sponsor.
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Exclusion Criteria:
Use of virtual reality with head mounted display
Device: OnComfort autohypnosis
Treatment as usual
Other: Treatment as usual, without the OnComfort autohypnosis system
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.
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.
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.
Time frame: Day 1 (Immediately after the peripheral vascular intervention)
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Adverse events
Device deficiencies
Time frame: Day 1
Serious adverse events
Amputation, mesenteric or renal ischemia, and death
Time frame: Day 90
Plan to share: No
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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