Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04561596
• Other study ID #: 2020-00728
• Status: Completed
• Phase: N/A
• Start date: September 23, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 31, 2022
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Postoperative
• Pain, Postoperative
• Vascular Access Site Pain

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Salah D. Qanadli, MD, PhD

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	Adverse events	Device deficiencies	Day 1
Secondary	Serious adverse events	Amputation, mesenteric or renal ischemia, and death	Day 90