Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions

Not Applicable

Completed

• Conditions: Vascular Access Site Pain; Anxiety Postoperative; Pain, Postoperative
• Interventions: Other: Treatment as usual, without the OnComfort autohypnosis system; Device: OnComfort autohypnosis

• Registration Number: NCT04561596
• Lead Sponsor: Salah D. Qanadli, MD, PhD

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.

Study Timeline

• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-17
• Study Start: 2020-09-23
• Study First Posted: 2020-09-23
• Primary Completion: 2020-10-05
• Study Completion: 2022-08-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Treatment as usual, without the OnComfort autohypnosis system	Treatment as usual
Autohypnosis	OnComfort autohypnosis	Use of virtual reality with head mounted display

Primary Outcome Measures

Name	Time	Method
Per procedural anxiety.	Day 1 (Immediately after the peripheral vascular intervention)	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

Name	Time	Method
Adverse events	Day 1	Device deficiencies
Remembered per procedural anxiety.	3 months	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.
Per procedural pain.	Day 1 (Immediately after the peripheral vascular intervention)	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 pain.	3 months	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.
Serious adverse events	Day 90	Amputation, mesenteric or renal ischemia, and death

Trial Locations

Locations (1)

CHUV; 🇨🇭 Lausanne, Vaud, Switzerland